LABELS · 09faf8e7-1a0f-4db3-94b0-090d7a6791e5

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: 2025-10-27
Captured: 2026-09-09T23:37:39.774134+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 erythroderma, 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, nonsuppurative 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 ophthalmia, temporal arteritis, uveitis and 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=e8209047-c1e6-4081-a6d3-c603d9ee4f14

generic names

METHYLPREDNISOLONE ACETATE

09faf8e7-1a0f-4db3-94b0-090d7a6791e5

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 erythroderma, 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, nonsuppurative 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 ophthalmia, temporal arteritis, uveitis and 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

50090-1823-0

product ndcs

50090-1823

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

INTRALESIONAL
INTRAMUSCULAR
INTRASYNOVIAL
SOFT TISSUE

rxcuis

1358617
1358619

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00000.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: 09faf8e7-1a0f-4db3-94b0-090d7a6791e5
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 853cdeb3f552bca79ce6ec739155b94532a79ae63bf779bde5231228b6824ac1
start: 0

current approval status

not_reconciled

duplicate text group

dup-09e3cfc7a621dcaec149

extraction review status

automated_candidate_pending_source_review

generic names

METHYLPREDNISOLONE ACETATE

ind-span-d8f8bef861d470493f62

label id

09faf8e7-1a0f-4db3-94b0-090d7a6791e5

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 24
end exclusive: true
exact text: INDICATIONS AND USAGE A.
label id: 09faf8e7-1a0f-4db3-94b0-090d7a6791e5
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 853cdeb3f552bca79ce6ec739155b94532a79ae63bf779bde5231228b6824ac1
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%2209faf8e7-1a0f-4db3-94b0-090d7a6791e5%22

spl effective date

2025-10-27

spl set id

e8209047-c1e6-4081-a6d3-c603d9ee4f14

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: 770
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 erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders: Primary o
label id: 09faf8e7-1a0f-4db3-94b0-090d7a6791e5
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 853cdeb3f552bca79ce6ec739155b94532a79ae63bf779bde5231228b6824ac1
start: 0

current approval status

not_reconciled

duplicate text group

dup-3ef7adbaf58ba226b32a

extraction review status

automated_candidate_pending_source_review

generic names

METHYLPREDNISOLONE ACETATE

ind-span-0d5ff9bf00b356592e4d

label id

09faf8e7-1a0f-4db3-94b0-090d7a6791e5

positive predicate support span

end: 306
end exclusive: true
exact text: is indicated
label id: 09faf8e7-1a0f-4db3-94b0-090d7a6791e5
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 853cdeb3f552bca79ce6ec739155b94532a79ae63bf779bde5231228b6824ac1
start: 294

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 570
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: 09faf8e7-1a0f-4db3-94b0-090d7a6791e5
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 853cdeb3f552bca79ce6ec739155b94532a79ae63bf779bde5231228b6824ac1
start: 25

source url

https://api.fda.gov/drug/label.json?search=id%3A%2209faf8e7-1a0f-4db3-94b0-090d7a6791e5%22

spl effective date

2025-10-27

spl set id

e8209047-c1e6-4081-a6d3-c603d9ee4f14

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: 939
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 erythroderma, 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 a
label id: 09faf8e7-1a0f-4db3-94b0-090d7a6791e5
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 853cdeb3f552bca79ce6ec739155b94532a79ae63bf779bde5231228b6824ac1
start: 371

current approval status

not_reconciled

duplicate text group

dup-8cf851544c877f3822fe

extraction review status

automated_candidate_pending_source_review

generic names

METHYLPREDNISOLONE ACETATE

ind-span-647d82f1a6db765ff0de

label id

09faf8e7-1a0f-4db3-94b0-090d7a6791e5

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 739
end exclusive: true
exact text: Dermatologic Diseases : Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome).
label id: 09faf8e7-1a0f-4db3-94b0-090d7a6791e5
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 853cdeb3f552bca79ce6ec739155b94532a79ae63bf779bde5231228b6824ac1
start: 571

source url

https://api.fda.gov/drug/label.json?search=id%3A%2209faf8e7-1a0f-4db3-94b0-090d7a6791e5%22

spl effective date

2025-10-27

spl set id

e8209047-c1e6-4081-a6d3-c603d9ee4f14

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: 1323
end exclusive: true
exact text: ckness, transfusion reactions. Dermatologic Diseases : Bullous dermatitis herpetiformis, exfoliative erythroderma, 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, nonsuppurative 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) hemo
label id: 09faf8e7-1a0f-4db3-94b0-090d7a6791e5
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 853cdeb3f552bca79ce6ec739155b94532a79ae63bf779bde5231228b6824ac1
start: 540

current approval status

not_reconciled

duplicate text group

dup-3384afbf1e9dbad64cf8

extraction review status

automated_candidate_pending_source_review

generic names

METHYLPREDNISOLONE ACETATE

ind-span-a8555388ef6b47d85241

label id

09faf8e7-1a0f-4db3-94b0-090d7a6791e5

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 1123
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, nonsuppurative thyroiditis.
label id: 09faf8e7-1a0f-4db3-94b0-090d7a6791e5
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 853cdeb3f552bca79ce6ec739155b94532a79ae63bf779bde5231228b6824ac1
start: 740

source url

https://api.fda.gov/drug/label.json?search=id%3A%2209faf8e7-1a0f-4db3-94b0-090d7a6791e5%22

spl effective date

2025-10-27

spl set id

e8209047-c1e6-4081-a6d3-c603d9ee4f14

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: ticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative 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: 09faf8e7-1a0f-4db3-94b0-090d7a6791e5
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 853cdeb3f552bca79ce6ec739155b94532a79ae63bf779bde5231228b6824ac1
start: 924

current approval status

not_reconciled

duplicate text group

dup-70ae2971cf7b20833564

extraction review status

automated_candidate_pending_source_review

generic names

METHYLPREDNISOLONE ACETATE

ind-span-46b0e9d2eb13c6171cb6

label id

09faf8e7-1a0f-4db3-94b0-090d7a6791e5

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

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: 09faf8e7-1a0f-4db3-94b0-090d7a6791e5
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 853cdeb3f552bca79ce6ec739155b94532a79ae63bf779bde5231228b6824ac1
start: 1124

source url

https://api.fda.gov/drug/label.json?search=id%3A%2209faf8e7-1a0f-4db3-94b0-090d7a6791e5%22

spl effective date

2025-10-27

spl set id

e8209047-c1e6-4081-a6d3-c603d9ee4f14

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: 1672
end exclusive: true
exact text: sociated with cancer, nonsuppurative 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 chemoth
label id: 09faf8e7-1a0f-4db3-94b0-090d7a6791e5
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 853cdeb3f552bca79ce6ec739155b94532a79ae63bf779bde5231228b6824ac1
start: 1074

current approval status

not_reconciled

duplicate text group

dup-f1ffb86af2e18f36d4ad

extraction review status

automated_candidate_pending_source_review

generic names

METHYLPREDNISOLONE ACETATE

ind-span-42f0d73de7eb9edc7860

label id

09faf8e7-1a0f-4db3-94b0-090d7a6791e5

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 1472
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: 09faf8e7-1a0f-4db3-94b0-090d7a6791e5
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 853cdeb3f552bca79ce6ec739155b94532a79ae63bf779bde5231228b6824ac1
start: 1274

source url

https://api.fda.gov/drug/label.json?search=id%3A%2209faf8e7-1a0f-4db3-94b0-090d7a6791e5%22

spl effective date

2025-10-27

spl set id

e8209047-c1e6-4081-a6d3-c603d9ee4f14

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: 1878
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: Sympath
label id: 09faf8e7-1a0f-4db3-94b0-090d7a6791e5
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 853cdeb3f552bca79ce6ec739155b94532a79ae63bf779bde5231228b6824ac1
start: 1273

current approval status

not_reconciled

duplicate text group

dup-f6ab2e7ac886cf17564b

extraction review status

automated_candidate_pending_source_review

generic names

METHYLPREDNISOLONE ACETATE

ind-span-f323b8d7ad7781da387a

label id

09faf8e7-1a0f-4db3-94b0-090d7a6791e5

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 1678
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: 09faf8e7-1a0f-4db3-94b0-090d7a6791e5
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 853cdeb3f552bca79ce6ec739155b94532a79ae63bf779bde5231228b6824ac1
start: 1473

source url

https://api.fda.gov/drug/label.json?search=id%3A%2209faf8e7-1a0f-4db3-94b0-090d7a6791e5%22

spl effective date

2025-10-27

spl set id

e8209047-c1e6-4081-a6d3-c603d9ee4f14

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: 1953
end exclusive: true
exact text: laneous: 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 ophthalmia, temporal arteritis, uveitis and ocular inflammatory condit
label id: 09faf8e7-1a0f-4db3-94b0-090d7a6791e5
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 853cdeb3f552bca79ce6ec739155b94532a79ae63bf779bde5231228b6824ac1
start: 1479

current approval status

not_reconciled

duplicate text group

dup-2047520a0c3ebd33edb7

extraction review status

automated_candidate_pending_source_review

generic names

METHYLPREDNISOLONE ACETATE

ind-span-852d0df0b13b5c846cad

label id

09faf8e7-1a0f-4db3-94b0-090d7a6791e5

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 1753
end exclusive: true
exact text: Neoplastic Diseases: For palliative management of leukemias and lymphomas.
label id: 09faf8e7-1a0f-4db3-94b0-090d7a6791e5
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 853cdeb3f552bca79ce6ec739155b94532a79ae63bf779bde5231228b6824ac1
start: 1679

source url

https://api.fda.gov/drug/label.json?search=id%3A%2209faf8e7-1a0f-4db3-94b0-090d7a6791e5%22

spl effective date

2025-10-27

spl set id

e8209047-c1e6-4081-a6d3-c603d9ee4f14

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: 2049
end exclusive: true
exact text: 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 ophthalmia, temporal arteritis, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal Diseases: To induce diuresis or remission of
label id: 09faf8e7-1a0f-4db3-94b0-090d7a6791e5
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 853cdeb3f552bca79ce6ec739155b94532a79ae63bf779bde5231228b6824ac1
start: 1554

current approval status

not_reconciled

duplicate text group

dup-c9d27f1c999f426c196d

extraction review status

automated_candidate_pending_source_review

generic names

METHYLPREDNISOLONE ACETATE

ind-span-ed414c36ede8ee3b97ad

label id

09faf8e7-1a0f-4db3-94b0-090d7a6791e5

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
1848
end exclusive
true
exact text
metastatic brain tumor or craniotomy
label id
09faf8e7-1a0f-4db3-94b0-090d7a6791e5
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
853cdeb3f552bca79ce6ec739155b94532a79ae63bf779bde5231228b6824ac1
start
1812
context exact
Nervous System: Cerebral edema associated with primary or metastatic brain tumor or craniotomy.
kind
stage_or_setting
polarity
not_inferred
span
end
1848
end exclusive
true
exact text
metastatic brain tumor or craniotomy
label id
09faf8e7-1a0f-4db3-94b0-090d7a6791e5
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
853cdeb3f552bca79ce6ec739155b94532a79ae63bf779bde5231228b6824ac1
start
1812

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 1849
end exclusive: true
exact text: Nervous System: Cerebral edema associated with primary or metastatic brain tumor or craniotomy.
label id: 09faf8e7-1a0f-4db3-94b0-090d7a6791e5
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 853cdeb3f552bca79ce6ec739155b94532a79ae63bf779bde5231228b6824ac1
start: 1754

source url

https://api.fda.gov/drug/label.json?search=id%3A%2209faf8e7-1a0f-4db3-94b0-090d7a6791e5%22

spl effective date

2025-10-27

spl set id

e8209047-c1e6-4081-a6d3-c603d9ee4f14

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: 2198
end exclusive: true
exact text: ntituberculous 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 ophthalmia, temporal arteritis, uveitis and 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 pul
label id: 09faf8e7-1a0f-4db3-94b0-090d7a6791e5
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 853cdeb3f552bca79ce6ec739155b94532a79ae63bf779bde5231228b6824ac1
start: 1650

current approval status

not_reconciled

duplicate text group

dup-720c31d815c361130a99

extraction review status

automated_candidate_pending_source_review

generic names

METHYLPREDNISOLONE ACETATE

ind-span-41e6a4a31945716e8674

label id

09faf8e7-1a0f-4db3-94b0-090d7a6791e5

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 1998
end exclusive: true
exact text: Ophthalmic Diseases: Sympathetic ophthalmia, temporal arteritis, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids.
label id: 09faf8e7-1a0f-4db3-94b0-090d7a6791e5
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 853cdeb3f552bca79ce6ec739155b94532a79ae63bf779bde5231228b6824ac1
start: 1850

source url

https://api.fda.gov/drug/label.json?search=id%3A%2209faf8e7-1a0f-4db3-94b0-090d7a6791e5%22

spl effective date

2025-10-27

spl set id

e8209047-c1e6-4081-a6d3-c603d9ee4f14

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: 2331
end exclusive: true
exact text: h primary or metastatic brain tumor or craniotomy. Ophthalmic Diseases: Sympathetic ophthalmia, temporal arteritis, uveitis and 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, symptom
label id: 09faf8e7-1a0f-4db3-94b0-090d7a6791e5
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 853cdeb3f552bca79ce6ec739155b94532a79ae63bf779bde5231228b6824ac1
start: 1799

current approval status

not_reconciled

duplicate text group

dup-9432f1f63df1763571ba

extraction review status

automated_candidate_pending_source_review

generic names

METHYLPREDNISOLONE ACETATE

ind-span-67a293da7073b7f86212

label id

09faf8e7-1a0f-4db3-94b0-090d7a6791e5

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 2131
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: 09faf8e7-1a0f-4db3-94b0-090d7a6791e5
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 853cdeb3f552bca79ce6ec739155b94532a79ae63bf779bde5231228b6824ac1
start: 1999

source url

https://api.fda.gov/drug/label.json?search=id%3A%2209faf8e7-1a0f-4db3-94b0-090d7a6791e5%22

spl effective date

2025-10-27

spl set id

e8209047-c1e6-4081-a6d3-c603d9ee4f14

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: 2548
end exclusive: true
exact text: r 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 spo
label id: 09faf8e7-1a0f-4db3-94b0-090d7a6791e5
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 853cdeb3f552bca79ce6ec739155b94532a79ae63bf779bde5231228b6824ac1
start: 1932

current approval status

not_reconciled

duplicate text group

dup-e645662e91cfe68f597d

extraction review status

automated_candidate_pending_source_review

generic names

METHYLPREDNISOLONE ACETATE

ind-span-9a6aeb4a1cd61f03a5ce

label id

09faf8e7-1a0f-4db3-94b0-090d7a6791e5

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 2348
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: 09faf8e7-1a0f-4db3-94b0-090d7a6791e5
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 853cdeb3f552bca79ce6ec739155b94532a79ae63bf779bde5231228b6824ac1
start: 2132

source url

https://api.fda.gov/drug/label.json?search=id%3A%2209faf8e7-1a0f-4db3-94b0-090d7a6791e5%22

spl effective date

2025-10-27

spl set id

e8209047-c1e6-4081-a6d3-c603d9ee4f14

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: 2899
end exclusive: true
exact text: ses: 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: 09faf8e7-1a0f-4db3-94b0-090d7a6791e5
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 853cdeb3f552bca79ce6ec739155b94532a79ae63bf779bde5231228b6824ac1
start: 2149

current approval status

not_reconciled

duplicate text group

dup-fe7890402a4f7ed7916c

extraction review status

automated_candidate_pending_source_review

generic names

METHYLPREDNISOLONE ACETATE

ind-span-90ca888c377f31d55106

label id

09faf8e7-1a0f-4db3-94b0-090d7a6791e5

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 2699
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: 09faf8e7-1a0f-4db3-94b0-090d7a6791e5
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 853cdeb3f552bca79ce6ec739155b94532a79ae63bf779bde5231228b6824ac1
start: 2349

source url

https://api.fda.gov/drug/label.json?search=id%3A%2209faf8e7-1a0f-4db3-94b0-090d7a6791e5%22

spl effective date

2025-10-27

spl set id

e8209047-c1e6-4081-a6d3-c603d9ee4f14

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: 2985
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: 09faf8e7-1a0f-4db3-94b0-090d7a6791e5
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 853cdeb3f552bca79ce6ec739155b94532a79ae63bf779bde5231228b6824ac1
start: 2500

current approval status

not_reconciled

duplicate text group

dup-5654cca9c77ee4f7c775

extraction review status

automated_candidate_pending_source_review

generic names

METHYLPREDNISOLONE ACETATE

ind-span-3df5cf87fa6fe56ffe27

label id

09faf8e7-1a0f-4db3-94b0-090d7a6791e5

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 2785
end exclusive: true
exact text: For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.
label id: 09faf8e7-1a0f-4db3-94b0-090d7a6791e5
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 853cdeb3f552bca79ce6ec739155b94532a79ae63bf779bde5231228b6824ac1
start: 2700

source url

https://api.fda.gov/drug/label.json?search=id%3A%2209faf8e7-1a0f-4db3-94b0-090d7a6791e5%22

spl effective date

2025-10-27

spl set id

e8209047-c1e6-4081-a6d3-c603d9ee4f14

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: 2988
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: 09faf8e7-1a0f-4db3-94b0-090d7a6791e5
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 853cdeb3f552bca79ce6ec739155b94532a79ae63bf779bde5231228b6824ac1
start: 2586

current approval status

not_reconciled

duplicate text group

dup-f93c95d98fcb28ba3298

extraction review status

automated_candidate_pending_source_review

generic names

METHYLPREDNISOLONE ACETATE

ind-span-01308aa1e0d8881807ab

label id

09faf8e7-1a0f-4db3-94b0-090d7a6791e5

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 2788
end exclusive: true
exact text: B.
label id: 09faf8e7-1a0f-4db3-94b0-090d7a6791e5
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 853cdeb3f552bca79ce6ec739155b94532a79ae63bf779bde5231228b6824ac1
start: 2786

source url

https://api.fda.gov/drug/label.json?search=id%3A%2209faf8e7-1a0f-4db3-94b0-090d7a6791e5%22

spl effective date

2025-10-27

spl set id

e8209047-c1e6-4081-a6d3-c603d9ee4f14

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: 3345
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
label id: 09faf8e7-1a0f-4db3-94b0-090d7a6791e5
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 853cdeb3f552bca79ce6ec739155b94532a79ae63bf779bde5231228b6824ac1
start: 2589

current approval status

not_reconciled

duplicate text group

dup-2b79cf8786203cefcb4a

extraction review status

automated_candidate_pending_source_review

generic names

METHYLPREDNISOLONE ACETATE

ind-span-0e697e9af0f1dcfe5715

label id

09faf8e7-1a0f-4db3-94b0-090d7a6791e5

positive predicate support span

end: 2879
end exclusive: true
exact text: is indicated
label id: 09faf8e7-1a0f-4db3-94b0-090d7a6791e5
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 853cdeb3f552bca79ce6ec739155b94532a79ae63bf779bde5231228b6824ac1
start: 2867

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 3145
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: 09faf8e7-1a0f-4db3-94b0-090d7a6791e5
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 853cdeb3f552bca79ce6ec739155b94532a79ae63bf779bde5231228b6824ac1
start: 2789

source url

https://api.fda.gov/drug/label.json?search=id%3A%2209faf8e7-1a0f-4db3-94b0-090d7a6791e5%22

spl effective date

2025-10-27

spl set id

e8209047-c1e6-4081-a6d3-c603d9ee4f14

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: 3348
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
label id: 09faf8e7-1a0f-4db3-94b0-090d7a6791e5
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 853cdeb3f552bca79ce6ec739155b94532a79ae63bf779bde5231228b6824ac1
start: 2946

current approval status

not_reconciled

duplicate text group

dup-b0ff41cebcf32914aea2

extraction review status

automated_candidate_pending_source_review

generic names

METHYLPREDNISOLONE ACETATE

ind-span-d70ad9d177107b1152f8

label id

09faf8e7-1a0f-4db3-94b0-090d7a6791e5

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 3148
end exclusive: true
exact text: C.
label id: 09faf8e7-1a0f-4db3-94b0-090d7a6791e5
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 853cdeb3f552bca79ce6ec739155b94532a79ae63bf779bde5231228b6824ac1
start: 3146

source url

https://api.fda.gov/drug/label.json?search=id%3A%2209faf8e7-1a0f-4db3-94b0-090d7a6791e5%22

spl effective date

2025-10-27

spl set id

e8209047-c1e6-4081-a6d3-c603d9ee4f14

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: 3572
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: 09faf8e7-1a0f-4db3-94b0-090d7a6791e5
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 853cdeb3f552bca79ce6ec739155b94532a79ae63bf779bde5231228b6824ac1
start: 2949

current approval status

not_reconciled

duplicate text group

dup-f3f96efd80789a457416

extraction review status

automated_candidate_pending_source_review

generic names

METHYLPREDNISOLONE ACETATE

ind-span-e3a4b1d6f194535757aa

label id

09faf8e7-1a0f-4db3-94b0-090d7a6791e5

positive predicate support span

end: 3206
end exclusive: true
exact text: is indicated
label id: 09faf8e7-1a0f-4db3-94b0-090d7a6791e5
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 853cdeb3f552bca79ce6ec739155b94532a79ae63bf779bde5231228b6824ac1
start: 3194

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 3485
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: 09faf8e7-1a0f-4db3-94b0-090d7a6791e5
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 853cdeb3f552bca79ce6ec739155b94532a79ae63bf779bde5231228b6824ac1
start: 3149

source url

https://api.fda.gov/drug/label.json?search=id%3A%2209faf8e7-1a0f-4db3-94b0-090d7a6791e5%22

spl effective date

2025-10-27

spl set id

e8209047-c1e6-4081-a6d3-c603d9ee4f14

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: 3572
end exclusive: true
exact text: 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: 09faf8e7-1a0f-4db3-94b0-090d7a6791e5
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 853cdeb3f552bca79ce6ec739155b94532a79ae63bf779bde5231228b6824ac1
start: 3286

current approval status

not_reconciled

duplicate text group

dup-c5ee27c4c78934679917

extraction review status

automated_candidate_pending_source_review

generic names

METHYLPREDNISOLONE ACETATE

ind-span-98fd69bc7e61aacaa8a6

label id

09faf8e7-1a0f-4db3-94b0-090d7a6791e5

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07

source defined aliases

source span

end: 3572
end exclusive: true
exact text: DEPO-MEDROL also may be useful in cystic tumors of an aponeurosis or tendon (ganglia).
label id: 09faf8e7-1a0f-4db3-94b0-090d7a6791e5
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 853cdeb3f552bca79ce6ec739155b94532a79ae63bf779bde5231228b6824ac1
start: 3486

source url

https://api.fda.gov/drug/label.json?search=id%3A%2209faf8e7-1a0f-4db3-94b0-090d7a6791e5%22

spl effective date

2025-10-27

spl set id

e8209047-c1e6-4081-a6d3-c603d9ee4f14

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