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LABELS · e4917f75-3e1c-4f3c-803d-d9ec65df06c7

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
2025-12-01
Captured
2026-09-09T23:38:02.384588+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 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
  1. NDA011757
boxed warning exact
    brand names
    1. Depo-Medrol
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bf1b104d-85cb-414d-a366-78068c82c883
    generic names
    1. METHYLPREDNISOLONE ACETATE
    id
    e4917f75-3e1c-4f3c-803d-d9ec65df06c7
    indications and usage exact
    1. 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
      1. true
      manufacturer names
      1. Pharmacia & Upjohn Company LLC
      matched search terms
      1. cancer
      2. lymphomas
      3. tumor
      4. tumors
      package ndcs
      1. 0009-3073-22
      2. 0009-3073-23
      3. 0009-3475-22
      4. 0009-3475-23
      product ndcs
      1. 0009-3073
      2. 0009-3475
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
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        routes
        1. INTRALESIONAL
        2. INTRAMUSCULAR
        3. INTRASYNOVIAL
        4. SOFT TISSUE
        rxcuis
        1. 1743779
        2. 1743781
        3. 1743855
        4. 1743856
        source batch
        file
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        spl effective date
        2025-12-01
        spl effective time
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        substance names
        1. METHYLPREDNISOLONE ACETATE
        uniis
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        verification flags
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        Drugs@FDA application source records
        1. application number
          NDA011757
          payload
          all indexed label documents
          1. Appl No
            011757
            Application Docs Date
            2009-04-16 00:00:00
            Application Docs ID
            10777
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            85
            Submission Type
            SUPPL
          2. Appl No
            011757
            Application Docs Date
            2014-07-09 00:00:00
            Application Docs ID
            10778
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            103
            Submission Type
            SUPPL
          3. Appl No
            011757
            Application Docs Date
            2009-04-16 00:00:00
            Application Docs ID
            33055
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            86
            Submission Type
            SUPPL
          4. Appl No
            011757
            Application Docs Date
            2016-09-09 00:00:00
            Application Docs ID
            45261
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            104
            Submission Type
            SUPPL
          5. Appl No
            011757
            Application Docs Date
            2018-07-25 00:00:00
            Application Docs ID
            54964
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            114
            Submission Type
            SUPPL
          6. Appl No
            011757
            Application Docs Date
            2020-07-29 00:00:00
            Application Docs ID
            64124
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            111
            Submission Type
            SUPPL
          7. Appl No
            011757
            Application Docs Date
            2021-02-16 00:00:00
            Application Docs ID
            66223
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            119
            Submission Type
            SUPPL
          8. Appl No
            011757
            Application Docs Date
            2021-06-04 00:00:00
            Application Docs ID
            67702
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            120
            Submission Type
            SUPPL
          9. Appl No
            011757
            Application Docs Date
            2023-12-21 00:00:00
            Application Docs ID
            77104
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            123
            Submission Type
            SUPPL
          10. Appl No
            011757
            Application Docs Date
            2024-06-06 00:00:00
            Application Docs ID
            78674
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            125
            Submission Type
            SUPPL
          11. Appl No
            011757
            Application Docs Date
            2025-11-07 00:00:00
            Application Docs ID
            84123
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            124
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            011757
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            125
            Submission Status
            AP
            Submission Status Date
            2024-06-05 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          2. Appl No
            011757
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            124
            Submission Status
            AP
            Submission Status Date
            2025-11-04 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            011757
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            123
            Submission Status
            AP
            Submission Status Date
            2023-12-20 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            011757
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            120
            Submission Status
            AP
            Submission Status Date
            2021-05-27 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            011757
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            119
            Submission Status
            AP
            Submission Status Date
            2021-02-11 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          6. Appl No
            011757
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            114
            Submission Status
            AP
            Submission Status Date
            2018-07-24 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          7. Appl No
            011757
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            111
            Submission Status
            AP
            Submission Status Date
            2017-03-15 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          8. Appl No
            011757
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            104
            Submission Status
            AP
            Submission Status Date
            2016-09-08 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          9. Appl No
            011757
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            103
            Submission Status
            AP
            Submission Status Date
            2014-07-03 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          10. Appl No
            011757
            Review Priority
            STANDARD
            Submission Class Code ID
            4
            Submission No
            102
            Submission Status
            AP
            Submission Status Date
            2014-06-09 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          11. Appl No
            011757
            Review Priority
            STANDARD
            Submission Class Code ID
            4
            Submission No
            98
            Submission Status
            AP
            Submission Status Date
            2013-10-11 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          12. Appl No
            011757
            Review Priority
            STANDARD
            Submission Class Code ID
            4
            Submission No
            97
            Submission Status
            AP
            Submission Status Date
            2013-10-07 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA011757
          approval interpretation
          Application linkage and approved submission are not indication-level current approval verification
          current indication status
          not_reconciled
          has approved submission record
          true
          latest approved submission date
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          latest posted label documents
          1. Appl No
            011757
            Application Docs Date
            2025-11-07 00:00:00
            Application Docs ID
            84123
            Application Docs Title
            0
            Application Docs Type ID
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            Submission No
            124
            Submission Type
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          Appl No
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          Appl Public Notes
          Appl Type
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          Sponsor Name
          PFIZER
          openfda application present
          true
          products
          1. Active Ingredient
            METHYLPREDNISOLONE ACETATE
            Appl No
            011757
            Drug Name
            DEPO-MEDROL
            Form
            INJECTABLE;INJECTION
            Product No
            001
            Reference Drug
            1
            Reference Standard
            0
            Strength
            40MG/ML
            marketing status
            1. Prescription
          2. Active Ingredient
            METHYLPREDNISOLONE ACETATE
            Appl No
            011757
            Drug Name
            DEPO-MEDROL
            Form
            INJECTABLE;INJECTION
            Product No
            002
            Reference Drug
            1
            Reference Standard
            1
            Strength
            20MG/ML
            marketing status
            1. Prescription
          3. Active Ingredient
            METHYLPREDNISOLONE ACETATE
            Appl No
            011757
            Drug Name
            DEPO-MEDROL
            Form
            INJECTABLE;INJECTION
            Product No
            004
            Reference Drug
            1
            Reference Standard
            0
            Strength
            80MG/ML
            marketing status
            1. Prescription

        Source passages and status connections

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        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
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              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
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                    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.
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                                                                                                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
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                                                                                                      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.
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                                                                                                      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
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                                                                                                                  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.
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                                                                                                                        Preserved source evidence · Not medical advice