LABELS · 3cb9b45d-cbb7-4812-a239-ba572781666b

DEPO-MEDROL

Open original source → · Download preserved record

Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date: 2025-11-06
Captured: 2026-09-09T23:37:44.904352+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

INDICATIONS AND USAGE A. For Intramuscular Administration When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intramuscular use of DEPO-MEDROL Sterile Aqueous Suspension is indicated as follows: Allergic States : Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic Diseases : Bullous dermatitis herpetiformis, exfoliative dermatitis, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders : Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsupportive thyroiditis. Gastrointestinal Diseases : To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic Disorders : Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), pure red cell aplasia, select cases of secondary thrombocytopenia. Miscellaneous : Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic Diseases : For palliative management of: leukemias and lymphomas. Nervous System : Cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic Diseases : Sympathetic opthalmia, temporal arteritis, uveitis, ocular inflammatory conditions unresponsive to topical corticosteroids. Renal Diseases : To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus. Respiratory Diseases : Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic Disorders : As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus. B. For Intra-articular Or Soft Tissue Administration (see WARNINGS ) DEPO-MEDROL is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis. C. For Intralesional Administration DEPO-MEDROL is indicated for intralesional use in alopecia areata, discoid lupus erythematosus; keloids, localized hypertrophic, infiltrated inflammatory lesions of granuloma annulare, lichen planus, lichen simplex chronicus (neurodermatitis) and psoriatic plaques; necrobiosis lipoidica diabeticorum. DEPO-MEDROL also may be useful in cystic tumors of an aponeurosis or tendon (ganglia).

Full extracted label fields

application numbers

NDA011757

boxed warning exact

brand names

DEPO-MEDROL

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cb457bef-8823-4f3c-987b-eb0922494c46

generic names

METHYLPREDNISOLONE ACETATE

3cb9b45d-cbb7-4812-a239-ba572781666b

indications and usage exact

INDICATIONS AND USAGE A. For Intramuscular Administration When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intramuscular use of DEPO-MEDROL Sterile Aqueous Suspension is indicated as follows: Allergic States : Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic Diseases : Bullous dermatitis herpetiformis, exfoliative dermatitis, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders : Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsupportive thyroiditis. Gastrointestinal Diseases : To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic Disorders : Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), pure red cell aplasia, select cases of secondary thrombocytopenia. Miscellaneous : Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic Diseases : For palliative management of: leukemias and lymphomas. Nervous System : Cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic Diseases : Sympathetic opthalmia, temporal arteritis, uveitis, ocular inflammatory conditions unresponsive to topical corticosteroids. Renal Diseases : To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus. Respiratory Diseases : Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic Disorders : As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus. B. For Intra-articular Or Soft Tissue Administration (see WARNINGS ) DEPO-MEDROL is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis. C. For Intralesional Administration DEPO-MEDROL is indicated for intralesional use in alopecia areata, discoid lupus erythematosus; keloids, localized hypertrophic, infiltrated inflammatory lesions of granuloma annulare, lichen planus, lichen simplex chronicus (neurodermatitis) and psoriatic plaques; necrobiosis lipoidica diabeticorum. DEPO-MEDROL also may be useful in cystic tumors of an aponeurosis or tendon (ganglia).

indications and usage tables exact

is original packager

manufacturer names

A-S Medication Solutions

matched search terms

cancer
lymphomas
tumor
tumors

package ndcs

50090-2098-0

product ndcs

50090-2098

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

INTRA-ARTICULAR
INTRALESIONAL
INTRAMUSCULAR
SOFT TISSUE

rxcuis

1743779
1743781

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00200.json

Source passages and status connections

Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

Passage 1 · unclassified context

application numbers

NDA011757

brand names

DEPO-MEDROL

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 224
end exclusive: true
exact text: INDICATIONS AND USAGE A. For Intramuscular Administration When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condi
label id: 3cb9b45d-cbb7-4812-a239-ba572781666b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b2ed8b1eb43ec95b05b72f6f1ed6778577d88469016d33c5f129b63a8968be83
start: 0

current approval status

not_reconciled

duplicate text group

dup-4acbaae211b48c5f78ec

extraction review status

automated_candidate_pending_source_review

generic names

METHYLPREDNISOLONE ACETATE

ind-span-3c1d63c1a63ca1a1e26b

label id

3cb9b45d-cbb7-4812-a239-ba572781666b

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 24
end exclusive: true
exact text: INDICATIONS AND USAGE A.
label id: 3cb9b45d-cbb7-4812-a239-ba572781666b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b2ed8b1eb43ec95b05b72f6f1ed6778577d88469016d33c5f129b63a8968be83
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%223cb9b45d-cbb7-4812-a239-ba572781666b%22

spl effective date

2025-11-06

spl set id

cb457bef-8823-4f3c-987b-eb0922494c46

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 2 · positive indication candidate

application numbers

NDA011757

brand names

DEPO-MEDROL

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 771
end exclusive: true
exact text: INDICATIONS AND USAGE A. For Intramuscular Administration When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intramuscular use of DEPO-MEDROL Sterile Aqueous Suspension is indicated as follows: Allergic States : Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic Diseases : Bullous dermatitis herpetiformis, exfoliative dermatitis, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders : Primary or
label id: 3cb9b45d-cbb7-4812-a239-ba572781666b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b2ed8b1eb43ec95b05b72f6f1ed6778577d88469016d33c5f129b63a8968be83
start: 0

current approval status

not_reconciled

duplicate text group

dup-b6d1eed14c624d9b6031

extraction review status

automated_candidate_pending_source_review

generic names

METHYLPREDNISOLONE ACETATE

ind-span-b2cb62693d7c6b776d2a

label id

3cb9b45d-cbb7-4812-a239-ba572781666b

positive predicate support span

end: 306
end exclusive: true
exact text: is indicated
label id: 3cb9b45d-cbb7-4812-a239-ba572781666b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b2ed8b1eb43ec95b05b72f6f1ed6778577d88469016d33c5f129b63a8968be83
start: 294

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 571
end exclusive: true
exact text: For Intramuscular Administration When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intramuscular use of DEPO-MEDROL Sterile Aqueous Suspension is indicated as follows: Allergic States : Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions.
label id: 3cb9b45d-cbb7-4812-a239-ba572781666b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b2ed8b1eb43ec95b05b72f6f1ed6778577d88469016d33c5f129b63a8968be83
start: 25

source url

https://api.fda.gov/drug/label.json?search=id%3A%223cb9b45d-cbb7-4812-a239-ba572781666b%22

spl effective date

2025-11-06

spl set id

cb457bef-8823-4f3c-987b-eb0922494c46

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

non_oncology_or_unclear_candidate

Passage 3 · unclassified context

application numbers

NDA011757

brand names

DEPO-MEDROL

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 938
end exclusive: true
exact text: allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic Diseases : Bullous dermatitis herpetiformis, exfoliative dermatitis, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders : Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where
label id: 3cb9b45d-cbb7-4812-a239-ba572781666b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b2ed8b1eb43ec95b05b72f6f1ed6778577d88469016d33c5f129b63a8968be83
start: 372

current approval status

not_reconciled

duplicate text group

dup-c06d857a11fc3ec5dccb

extraction review status

automated_candidate_pending_source_review

generic names

METHYLPREDNISOLONE ACETATE

ind-span-ea29cd083dc23131ca83

label id

3cb9b45d-cbb7-4812-a239-ba572781666b

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 738
end exclusive: true
exact text: Dermatologic Diseases : Bullous dermatitis herpetiformis, exfoliative dermatitis, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome).
label id: 3cb9b45d-cbb7-4812-a239-ba572781666b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b2ed8b1eb43ec95b05b72f6f1ed6778577d88469016d33c5f129b63a8968be83
start: 572

source url

https://api.fda.gov/drug/label.json?search=id%3A%223cb9b45d-cbb7-4812-a239-ba572781666b%22

spl effective date

2025-11-06

spl set id

cb457bef-8823-4f3c-987b-eb0922494c46

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 4 · unclassified context

application numbers

NDA011757

brand names

DEPO-MEDROL

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1322
end exclusive: true
exact text: sickness, transfusion reactions. Dermatologic Diseases : Bullous dermatitis herpetiformis, exfoliative dermatitis, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders : Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsupportive thyroiditis. Gastrointestinal Diseases : To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic Disorders : Acquired (autoimmune) he
label id: 3cb9b45d-cbb7-4812-a239-ba572781666b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b2ed8b1eb43ec95b05b72f6f1ed6778577d88469016d33c5f129b63a8968be83
start: 539

current approval status

not_reconciled

duplicate text group

dup-596b3ee7022104d49a1c

extraction review status

automated_candidate_pending_source_review

generic names

METHYLPREDNISOLONE ACETATE

ind-span-286acb052b4559f74604

label id

3cb9b45d-cbb7-4812-a239-ba572781666b

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 1122
end exclusive: true
exact text: Endocrine Disorders : Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsupportive thyroiditis.
label id: 3cb9b45d-cbb7-4812-a239-ba572781666b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b2ed8b1eb43ec95b05b72f6f1ed6778577d88469016d33c5f129b63a8968be83
start: 739

source url

https://api.fda.gov/drug/label.json?search=id%3A%223cb9b45d-cbb7-4812-a239-ba572781666b%22

spl effective date

2025-11-06

spl set id

cb457bef-8823-4f3c-987b-eb0922494c46

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 5 · unclassified context

application numbers

NDA011757

brand names

DEPO-MEDROL

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1473
end exclusive: true
exact text: rticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsupportive thyroiditis. Gastrointestinal Diseases : To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic Disorders : Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), pure red cell aplasia, select cases of secondary thrombocytopenia.
label id: 3cb9b45d-cbb7-4812-a239-ba572781666b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b2ed8b1eb43ec95b05b72f6f1ed6778577d88469016d33c5f129b63a8968be83
start: 923

current approval status

not_reconciled

duplicate text group

dup-81e0ebe1ac688390e74c

extraction review status

automated_candidate_pending_source_review

generic names

METHYLPREDNISOLONE ACETATE

ind-span-b0516b6fc7e4f43e0d57

label id

3cb9b45d-cbb7-4812-a239-ba572781666b

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 1273
end exclusive: true
exact text: Gastrointestinal Diseases : To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis.
label id: 3cb9b45d-cbb7-4812-a239-ba572781666b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b2ed8b1eb43ec95b05b72f6f1ed6778577d88469016d33c5f129b63a8968be83
start: 1123

source url

https://api.fda.gov/drug/label.json?search=id%3A%223cb9b45d-cbb7-4812-a239-ba572781666b%22

spl effective date

2025-11-06

spl set id

cb457bef-8823-4f3c-987b-eb0922494c46

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 6 · unclassified context

application numbers

NDA011757

brand names

DEPO-MEDROL

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1673
end exclusive: true
exact text: sociated with cancer, nonsupportive thyroiditis. Gastrointestinal Diseases : To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic Disorders : Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), pure red cell aplasia, select cases of secondary thrombocytopenia. Miscellaneous : Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemot
label id: 3cb9b45d-cbb7-4812-a239-ba572781666b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b2ed8b1eb43ec95b05b72f6f1ed6778577d88469016d33c5f129b63a8968be83
start: 1074

current approval status

not_reconciled

duplicate text group

dup-f239cdf27ca3cee04221

extraction review status

automated_candidate_pending_source_review

generic names

METHYLPREDNISOLONE ACETATE

ind-span-62297fde96e548b3d7b5

label id

3cb9b45d-cbb7-4812-a239-ba572781666b

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 1473
end exclusive: true
exact text: Hematologic Disorders : Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), pure red cell aplasia, select cases of secondary thrombocytopenia.
label id: 3cb9b45d-cbb7-4812-a239-ba572781666b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b2ed8b1eb43ec95b05b72f6f1ed6778577d88469016d33c5f129b63a8968be83
start: 1274

source url

https://api.fda.gov/drug/label.json?search=id%3A%223cb9b45d-cbb7-4812-a239-ba572781666b%22

spl effective date

2025-11-06

spl set id

cb457bef-8823-4f3c-987b-eb0922494c46

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 7 · unclassified context

application numbers

NDA011757

brand names

DEPO-MEDROL

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1880
end exclusive: true
exact text: Hematologic Disorders : Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), pure red cell aplasia, select cases of secondary thrombocytopenia. Miscellaneous : Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic Diseases : For palliative management of: leukemias and lymphomas. Nervous System : Cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic Diseases : Sym
label id: 3cb9b45d-cbb7-4812-a239-ba572781666b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b2ed8b1eb43ec95b05b72f6f1ed6778577d88469016d33c5f129b63a8968be83
start: 1274

current approval status

not_reconciled

duplicate text group

dup-395fdb68af3d5f23452a

extraction review status

automated_candidate_pending_source_review

generic names

METHYLPREDNISOLONE ACETATE

ind-span-e7340f5d5b52e61b3c83

label id

3cb9b45d-cbb7-4812-a239-ba572781666b

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 1680
end exclusive: true
exact text: Miscellaneous : Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy.
label id: 3cb9b45d-cbb7-4812-a239-ba572781666b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b2ed8b1eb43ec95b05b72f6f1ed6778577d88469016d33c5f129b63a8968be83
start: 1474

source url

https://api.fda.gov/drug/label.json?search=id%3A%223cb9b45d-cbb7-4812-a239-ba572781666b%22

spl effective date

2025-11-06

spl set id

cb457bef-8823-4f3c-987b-eb0922494c46

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 8 · unclassified context

application numbers

NDA011757

brand names

DEPO-MEDROL

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1957
end exclusive: true
exact text: aneous : Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic Diseases : For palliative management of: leukemias and lymphomas. Nervous System : Cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic Diseases : Sympathetic opthalmia, temporal arteritis, uveitis, ocular inflammatory conditio
label id: 3cb9b45d-cbb7-4812-a239-ba572781666b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b2ed8b1eb43ec95b05b72f6f1ed6778577d88469016d33c5f129b63a8968be83
start: 1481

current approval status

not_reconciled

duplicate text group

dup-4b2825e7c5e080113521

extraction review status

automated_candidate_pending_source_review

generic names

METHYLPREDNISOLONE ACETATE

ind-span-9df32f4537ca9e87f8bc

label id

3cb9b45d-cbb7-4812-a239-ba572781666b

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 1757
end exclusive: true
exact text: Neoplastic Diseases : For palliative management of: leukemias and lymphomas.
label id: 3cb9b45d-cbb7-4812-a239-ba572781666b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b2ed8b1eb43ec95b05b72f6f1ed6778577d88469016d33c5f129b63a8968be83
start: 1681

source url

https://api.fda.gov/drug/label.json?search=id%3A%223cb9b45d-cbb7-4812-a239-ba572781666b%22

spl effective date

2025-11-06

spl set id

cb457bef-8823-4f3c-987b-eb0922494c46

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 9 · unclassified context

application numbers

NDA011757

brand names

DEPO-MEDROL

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 2054
end exclusive: true
exact text: eningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic Diseases : For palliative management of: leukemias and lymphomas. Nervous System : Cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic Diseases : Sympathetic opthalmia, temporal arteritis, uveitis, ocular inflammatory conditions unresponsive to topical corticosteroids. Renal Diseases : To induce diuresis or remission of p
label id: 3cb9b45d-cbb7-4812-a239-ba572781666b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b2ed8b1eb43ec95b05b72f6f1ed6778577d88469016d33c5f129b63a8968be83
start: 1558

current approval status

not_reconciled

duplicate text group

dup-1c761f918ecd50747748

extraction review status

automated_candidate_pending_source_review

generic names

METHYLPREDNISOLONE ACETATE

ind-span-62ba4d1df9e93b72ce64

label id

3cb9b45d-cbb7-4812-a239-ba572781666b

positive predicate support span

Source null

qualifier mentions

context exact
Nervous System : Cerebral edema associated with primary or metastatic brain tumor or craniotomy.
kind
biomarker
polarity
not_inferred
span
end
1853
end exclusive
true
exact text
metastatic brain tumor or craniotomy
label id
3cb9b45d-cbb7-4812-a239-ba572781666b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
b2ed8b1eb43ec95b05b72f6f1ed6778577d88469016d33c5f129b63a8968be83
start
1817
context exact
Nervous System : Cerebral edema associated with primary or metastatic brain tumor or craniotomy.
kind
stage_or_setting
polarity
not_inferred
span
end
1853
end exclusive
true
exact text
metastatic brain tumor or craniotomy
label id
3cb9b45d-cbb7-4812-a239-ba572781666b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
b2ed8b1eb43ec95b05b72f6f1ed6778577d88469016d33c5f129b63a8968be83
start
1817

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 1854
end exclusive: true
exact text: Nervous System : Cerebral edema associated with primary or metastatic brain tumor or craniotomy.
label id: 3cb9b45d-cbb7-4812-a239-ba572781666b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b2ed8b1eb43ec95b05b72f6f1ed6778577d88469016d33c5f129b63a8968be83
start: 1758

source url

https://api.fda.gov/drug/label.json?search=id%3A%223cb9b45d-cbb7-4812-a239-ba572781666b%22

spl effective date

2025-11-06

spl set id

cb457bef-8823-4f3c-987b-eb0922494c46

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 10 · unclassified context

application numbers

NDA011757

brand names

DEPO-MEDROL

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 2200
end exclusive: true
exact text: tuberculous chemotherapy. Neoplastic Diseases : For palliative management of: leukemias and lymphomas. Nervous System : Cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic Diseases : Sympathetic opthalmia, temporal arteritis, uveitis, ocular inflammatory conditions unresponsive to topical corticosteroids. Renal Diseases : To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus. Respiratory Diseases : Berylliosis, fulminating or disseminated p
label id: 3cb9b45d-cbb7-4812-a239-ba572781666b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b2ed8b1eb43ec95b05b72f6f1ed6778577d88469016d33c5f129b63a8968be83
start: 1655

current approval status

not_reconciled

duplicate text group

dup-9589b908a5f3f2009642

extraction review status

automated_candidate_pending_source_review

generic names

METHYLPREDNISOLONE ACETATE

ind-span-9b771c1a2b2d5def7bb6

label id

3cb9b45d-cbb7-4812-a239-ba572781666b

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 2000
end exclusive: true
exact text: Ophthalmic Diseases : Sympathetic opthalmia, temporal arteritis, uveitis, ocular inflammatory conditions unresponsive to topical corticosteroids.
label id: 3cb9b45d-cbb7-4812-a239-ba572781666b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b2ed8b1eb43ec95b05b72f6f1ed6778577d88469016d33c5f129b63a8968be83
start: 1855

source url

https://api.fda.gov/drug/label.json?search=id%3A%223cb9b45d-cbb7-4812-a239-ba572781666b%22

spl effective date

2025-11-06

spl set id

cb457bef-8823-4f3c-987b-eb0922494c46

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 11 · unclassified context

application numbers

NDA011757

brand names

DEPO-MEDROL

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 2334
end exclusive: true
exact text: with primary or metastatic brain tumor or craniotomy. Ophthalmic Diseases : Sympathetic opthalmia, temporal arteritis, uveitis, ocular inflammatory conditions unresponsive to topical corticosteroids. Renal Diseases : To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus. Respiratory Diseases : Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, sympto
label id: 3cb9b45d-cbb7-4812-a239-ba572781666b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b2ed8b1eb43ec95b05b72f6f1ed6778577d88469016d33c5f129b63a8968be83
start: 1801

current approval status

not_reconciled

duplicate text group

dup-8d4b91b7e129a6de3220

extraction review status

automated_candidate_pending_source_review

generic names

METHYLPREDNISOLONE ACETATE

ind-span-830ad65e5e4d468b38c8

label id

3cb9b45d-cbb7-4812-a239-ba572781666b

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 2134
end exclusive: true
exact text: Renal Diseases : To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus.
label id: 3cb9b45d-cbb7-4812-a239-ba572781666b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b2ed8b1eb43ec95b05b72f6f1ed6778577d88469016d33c5f129b63a8968be83
start: 2001

source url

https://api.fda.gov/drug/label.json?search=id%3A%223cb9b45d-cbb7-4812-a239-ba572781666b%22

spl effective date

2025-11-06

spl set id

cb457bef-8823-4f3c-987b-eb0922494c46

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 12 · unclassified context

application numbers

NDA011757

brand names

DEPO-MEDROL

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 2552
end exclusive: true
exact text: inflammatory conditions unresponsive to topical corticosteroids. Renal Diseases : To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus. Respiratory Diseases : Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic Disorders : As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing sp
label id: 3cb9b45d-cbb7-4812-a239-ba572781666b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b2ed8b1eb43ec95b05b72f6f1ed6778577d88469016d33c5f129b63a8968be83
start: 1935

current approval status

not_reconciled

duplicate text group

dup-c1f7163146c77993aa71

extraction review status

automated_candidate_pending_source_review

generic names

METHYLPREDNISOLONE ACETATE

ind-span-c805e6e76717c6d6c868

label id

3cb9b45d-cbb7-4812-a239-ba572781666b

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 2352
end exclusive: true
exact text: Respiratory Diseases : Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis.
label id: 3cb9b45d-cbb7-4812-a239-ba572781666b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b2ed8b1eb43ec95b05b72f6f1ed6778577d88469016d33c5f129b63a8968be83
start: 2135

source url

https://api.fda.gov/drug/label.json?search=id%3A%223cb9b45d-cbb7-4812-a239-ba572781666b%22

spl effective date

2025-11-06

spl set id

cb457bef-8823-4f3c-987b-eb0922494c46

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 13 · unclassified context

application numbers

NDA011757

brand names

DEPO-MEDROL

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 2904
end exclusive: true
exact text: es : Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic Disorders : As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus. B. For Intra-articular Or Soft Tissue Administration (see WARNINGS ) DEPO-MEDROL is indicated as adjunctive thera
label id: 3cb9b45d-cbb7-4812-a239-ba572781666b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b2ed8b1eb43ec95b05b72f6f1ed6778577d88469016d33c5f129b63a8968be83
start: 2153

current approval status

not_reconciled

duplicate text group

dup-03166f516ea4752dd630

extraction review status

automated_candidate_pending_source_review

generic names

METHYLPREDNISOLONE ACETATE

ind-span-78328c8792cc5017c49f

label id

3cb9b45d-cbb7-4812-a239-ba572781666b

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 2704
end exclusive: true
exact text: Rheumatic Disorders : As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy).
label id: 3cb9b45d-cbb7-4812-a239-ba572781666b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b2ed8b1eb43ec95b05b72f6f1ed6778577d88469016d33c5f129b63a8968be83
start: 2353

source url

https://api.fda.gov/drug/label.json?search=id%3A%223cb9b45d-cbb7-4812-a239-ba572781666b%22

spl effective date

2025-11-06

spl set id

cb457bef-8823-4f3c-987b-eb0922494c46

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 14 · unclassified context

application numbers

NDA011757

brand names

DEPO-MEDROL

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 2990
end exclusive: true
exact text: hritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus. B. For Intra-articular Or Soft Tissue Administration (see WARNINGS ) DEPO-MEDROL is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerb
label id: 3cb9b45d-cbb7-4812-a239-ba572781666b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b2ed8b1eb43ec95b05b72f6f1ed6778577d88469016d33c5f129b63a8968be83
start: 2505

current approval status

not_reconciled

duplicate text group

dup-c902ff46fdfe06c321ab

extraction review status

automated_candidate_pending_source_review

generic names

METHYLPREDNISOLONE ACETATE

ind-span-2e8c8eb27cd7c3094f88

label id

3cb9b45d-cbb7-4812-a239-ba572781666b

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 2790
end exclusive: true
exact text: For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.
label id: 3cb9b45d-cbb7-4812-a239-ba572781666b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b2ed8b1eb43ec95b05b72f6f1ed6778577d88469016d33c5f129b63a8968be83
start: 2705

source url

https://api.fda.gov/drug/label.json?search=id%3A%223cb9b45d-cbb7-4812-a239-ba572781666b%22

spl effective date

2025-11-06

spl set id

cb457bef-8823-4f3c-987b-eb0922494c46

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 15 · unclassified context

application numbers

NDA011757

brand names

DEPO-MEDROL

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 2993
end exclusive: true
exact text: oid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus. B. For Intra-articular Or Soft Tissue Administration (see WARNINGS ) DEPO-MEDROL is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbati
label id: 3cb9b45d-cbb7-4812-a239-ba572781666b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b2ed8b1eb43ec95b05b72f6f1ed6778577d88469016d33c5f129b63a8968be83
start: 2591

current approval status

not_reconciled

duplicate text group

dup-c598622df14ba3fc13ce

extraction review status

automated_candidate_pending_source_review

generic names

METHYLPREDNISOLONE ACETATE

ind-span-f96ab908923f697ea33d

label id

3cb9b45d-cbb7-4812-a239-ba572781666b

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 2793
end exclusive: true
exact text: B.
label id: 3cb9b45d-cbb7-4812-a239-ba572781666b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b2ed8b1eb43ec95b05b72f6f1ed6778577d88469016d33c5f129b63a8968be83
start: 2791

source url

https://api.fda.gov/drug/label.json?search=id%3A%223cb9b45d-cbb7-4812-a239-ba572781666b%22

spl effective date

2025-11-06

spl set id

cb457bef-8823-4f3c-987b-eb0922494c46

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 16 · positive indication candidate

application numbers

NDA011757

brand names

DEPO-MEDROL

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement
positive_statement_also_contains_qualification_review_required

clinical review status

pending

content role

positive_indication_candidate

context span

end: 3350
end exclusive: true
exact text: arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus. B. For Intra-articular Or Soft Tissue Administration (see WARNINGS ) DEPO-MEDROL is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis. C. For Intralesional Administration DEPO-MEDROL is indicated for intralesional use in alopecia areata, discoid lupus erythematosus; keloids, localized hypertrophic, infiltrated inflammatory lesions o
label id: 3cb9b45d-cbb7-4812-a239-ba572781666b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b2ed8b1eb43ec95b05b72f6f1ed6778577d88469016d33c5f129b63a8968be83
start: 2594

current approval status

not_reconciled

duplicate text group

dup-cc993ad7932f9fea834c

extraction review status

automated_candidate_pending_source_review

generic names

METHYLPREDNISOLONE ACETATE

ind-span-adb61568b55d6cd2fffc

label id

3cb9b45d-cbb7-4812-a239-ba572781666b

positive predicate support span

end: 2884
end exclusive: true
exact text: is indicated
label id: 3cb9b45d-cbb7-4812-a239-ba572781666b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b2ed8b1eb43ec95b05b72f6f1ed6778577d88469016d33c5f129b63a8968be83
start: 2872

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 3150
end exclusive: true
exact text: For Intra-articular Or Soft Tissue Administration (see WARNINGS ) DEPO-MEDROL is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis.
label id: 3cb9b45d-cbb7-4812-a239-ba572781666b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b2ed8b1eb43ec95b05b72f6f1ed6778577d88469016d33c5f129b63a8968be83
start: 2794

source url

https://api.fda.gov/drug/label.json?search=id%3A%223cb9b45d-cbb7-4812-a239-ba572781666b%22

spl effective date

2025-11-06

spl set id

cb457bef-8823-4f3c-987b-eb0922494c46

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

non_oncology_or_unclear_candidate

Passage 17 · unclassified context

application numbers

NDA011757

brand names

DEPO-MEDROL

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 3353
end exclusive: true
exact text: atient over an acute episode or exacerbation) in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis. C. For Intralesional Administration DEPO-MEDROL is indicated for intralesional use in alopecia areata, discoid lupus erythematosus; keloids, localized hypertrophic, infiltrated inflammatory lesions of g
label id: 3cb9b45d-cbb7-4812-a239-ba572781666b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b2ed8b1eb43ec95b05b72f6f1ed6778577d88469016d33c5f129b63a8968be83
start: 2951

current approval status

not_reconciled

duplicate text group

dup-b6be46126d7f5c0dc895

extraction review status

automated_candidate_pending_source_review

generic names

METHYLPREDNISOLONE ACETATE

ind-span-770ebfeaa3975e91b433

label id

3cb9b45d-cbb7-4812-a239-ba572781666b

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 3153
end exclusive: true
exact text: C.
label id: 3cb9b45d-cbb7-4812-a239-ba572781666b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b2ed8b1eb43ec95b05b72f6f1ed6778577d88469016d33c5f129b63a8968be83
start: 3151

source url

https://api.fda.gov/drug/label.json?search=id%3A%223cb9b45d-cbb7-4812-a239-ba572781666b%22

spl effective date

2025-11-06

spl set id

cb457bef-8823-4f3c-987b-eb0922494c46

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 18 · positive indication candidate

application numbers

NDA011757

brand names

DEPO-MEDROL

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 3575
end exclusive: true
exact text: ent over an acute episode or exacerbation) in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis. C. For Intralesional Administration DEPO-MEDROL is indicated for intralesional use in alopecia areata, discoid lupus erythematosus; keloids, localized hypertrophic, infiltrated inflammatory lesions of granuloma annulare, lichen planus, lichen simplex chronicus (neurodermatitis) and psoriatic plaques; necrobiosis lipoidica diabeticorum. DEPO-MEDROL also may be useful in cystic tumors of an aponeurosis or tendon (ganglia).
label id: 3cb9b45d-cbb7-4812-a239-ba572781666b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b2ed8b1eb43ec95b05b72f6f1ed6778577d88469016d33c5f129b63a8968be83
start: 2954

current approval status

not_reconciled

duplicate text group

dup-290af6251ae728a2bdf9

extraction review status

automated_candidate_pending_source_review

generic names

METHYLPREDNISOLONE ACETATE

ind-span-6a8e3e8e88a9b03a98c3

label id

3cb9b45d-cbb7-4812-a239-ba572781666b

positive predicate support span

end: 3211
end exclusive: true
exact text: is indicated
label id: 3cb9b45d-cbb7-4812-a239-ba572781666b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b2ed8b1eb43ec95b05b72f6f1ed6778577d88469016d33c5f129b63a8968be83
start: 3199

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 3488
end exclusive: true
exact text: For Intralesional Administration DEPO-MEDROL is indicated for intralesional use in alopecia areata, discoid lupus erythematosus; keloids, localized hypertrophic, infiltrated inflammatory lesions of granuloma annulare, lichen planus, lichen simplex chronicus (neurodermatitis) and psoriatic plaques; necrobiosis lipoidica diabeticorum.
label id: 3cb9b45d-cbb7-4812-a239-ba572781666b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b2ed8b1eb43ec95b05b72f6f1ed6778577d88469016d33c5f129b63a8968be83
start: 3154

source url

https://api.fda.gov/drug/label.json?search=id%3A%223cb9b45d-cbb7-4812-a239-ba572781666b%22

spl effective date

2025-11-06

spl set id

cb457bef-8823-4f3c-987b-eb0922494c46

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

non_oncology_or_unclear_candidate

Passage 19 · unclassified context

application numbers

NDA011757

brand names

DEPO-MEDROL

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 3575
end exclusive: true
exact text: s, localized hypertrophic, infiltrated inflammatory lesions of granuloma annulare, lichen planus, lichen simplex chronicus (neurodermatitis) and psoriatic plaques; necrobiosis lipoidica diabeticorum. DEPO-MEDROL also may be useful in cystic tumors of an aponeurosis or tendon (ganglia).
label id: 3cb9b45d-cbb7-4812-a239-ba572781666b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b2ed8b1eb43ec95b05b72f6f1ed6778577d88469016d33c5f129b63a8968be83
start: 3289

current approval status

not_reconciled

duplicate text group

dup-04727b1b2cd10c7a363d

extraction review status

automated_candidate_pending_source_review

generic names

METHYLPREDNISOLONE ACETATE

ind-span-5253f9d1431b9c6992a8

label id

3cb9b45d-cbb7-4812-a239-ba572781666b

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 3575
end exclusive: true
exact text: DEPO-MEDROL also may be useful in cystic tumors of an aponeurosis or tendon (ganglia).
label id: 3cb9b45d-cbb7-4812-a239-ba572781666b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b2ed8b1eb43ec95b05b72f6f1ed6778577d88469016d33c5f129b63a8968be83
start: 3489

source url

https://api.fda.gov/drug/label.json?search=id%3A%223cb9b45d-cbb7-4812-a239-ba572781666b%22

spl effective date

2025-11-06

spl set id

cb457bef-8823-4f3c-987b-eb0922494c46

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Preserved source evidence · Not medical advice