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LABELS · a4f97750-d5aa-8236-e053-2995a90a1854

KENALOG-40

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
2020-05-06
Captured
2026-09-09T23:37:54.830918+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. INDICATIONS AND USAGE Intramuscular Where oral therapy is not feasible, injectable corticosteroid therapy, including Kenalog-40 Injection (triamcinolone acetonide injectable suspension, USP) are indicated for intramuscular use 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, perennial or seasonal allergic rhinitis, 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 and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous system: Acute exacerbations of multiple sclerosis; 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. Intra-Articular The intra-articular or soft tissue administration of Kenalog-40 Injection are 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.
Full extracted label fields
application numbers
  1. NDA014901
boxed warning exact
    brand names
    1. KENALOG-40
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0bc9c75f-963c-40b0-995b-dfcbd50371a5
    generic names
    1. TRIAMCINOLONE ACETONIDE
    id
    a4f97750-d5aa-8236-e053-2995a90a1854
    indications and usage exact
    1. INDICATIONS AND USAGE Intramuscular Where oral therapy is not feasible, injectable corticosteroid therapy, including Kenalog-40 Injection (triamcinolone acetonide injectable suspension, USP) are indicated for intramuscular use 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, perennial or seasonal allergic rhinitis, 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 and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous system: Acute exacerbations of multiple sclerosis; 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. Intra-Articular The intra-articular or soft tissue administration of Kenalog-40 Injection are 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.
    indications and usage tables exact
      is original packager
        manufacturer names
        1. Asclemed USA, Inc.
        matched search terms
        1. cancer
        2. lymphomas
        3. tumor
        package ndcs
        1. 76420-085-01
        product ndcs
        1. 76420-085
        product types
        1. HUMAN PRESCRIPTION DRUG
        recent major changes exact
          record type
          complete_spl_indications_section_candidate
          routes
          1. INTRA-ARTICULAR
          2. INTRAMUSCULAR
          rxcuis
          1. 1085754
          2. 1085756
          source batch
          file
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          meta
          disclaimer
          Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
          last updated
          2026-09-09
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          url
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          source url
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          spl effective date
          2020-05-06
          spl effective time
          20200506
          spl set id
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          spl version
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          substance names
          1. TRIAMCINOLONE ACETONIDE
          uniis
          1. F446C597KA
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          Drugs@FDA application source records
          1. application number
            NDA014901
            payload
            all indexed label documents
            1. Appl No
              014901
              Application Docs Date
              2006-11-22 00:00:00
              Application Docs ID
              10850
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              34
              Submission Type
              SUPPL
            2. Appl No
              014901
              Application Docs Date
              2010-02-04 00:00:00
              Application Docs ID
              10851
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              37
              Submission Type
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            3. Appl No
              014901
              Application Docs Date
              2014-07-09 00:00:00
              Application Docs ID
              10852
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              42
              Submission Type
              SUPPL
            4. Appl No
              014901
              Application Docs Date
              2011-06-16 00:00:00
              Application Docs ID
              33127
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              38
              Submission Type
              SUPPL
            5. Appl No
              014901
              Application Docs Date
              2011-07-18 00:00:00
              Application Docs ID
              33128
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              39
              Submission Type
              SUPPL
            6. Appl No
              014901
              Application Docs Date
              2018-04-01 00:00:00
              Application Docs ID
              53573
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              44
              Submission Type
              SUPPL
            7. Appl No
              014901
              Application Docs Date
              2018-06-28 00:00:00
              Application Docs ID
              54712
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              45
              Submission Type
              SUPPL
            8. Appl No
              014901
              Application Docs Date
              2020-05-19 00:00:00
              Application Docs ID
              63087
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              47
              Submission Type
              SUPPL
            9. Appl No
              014901
              Application Docs Date
              2024-06-06 00:00:00
              Application Docs ID
              78680
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              54
              Submission Type
              SUPPL
            10. Appl No
              014901
              Application Docs Date
              2024-11-18 00:00:00
              Application Docs ID
              80226
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              55
              Submission Type
              SUPPL
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            1. Appl No
              014901
              Review Priority
              N/A
              Submission Class Code ID
              4
              Submission No
              55
              Submission Status
              AP
              Submission Status Date
              2024-08-09 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            2. Appl No
              014901
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              54
              Submission Status
              AP
              Submission Status Date
              2024-06-05 00:00:00
              Submission Type
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              Submissions Public Notes
            3. Appl No
              014901
              Review Priority
              STANDARD
              Submission Class Code ID
              4
              Submission No
              47
              Submission Status
              AP
              Submission Status Date
              2019-04-12 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            4. Appl No
              014901
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              45
              Submission Status
              AP
              Submission Status Date
              2018-06-22 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            5. Appl No
              014901
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              44
              Submission Status
              AP
              Submission Status Date
              2018-03-29 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            6. Appl No
              014901
              Review Priority
              STANDARD
              Submission Class Code ID
              4
              Submission No
              43
              Submission Status
              AP
              Submission Status Date
              2015-10-26 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            7. Appl No
              014901
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              42
              Submission Status
              AP
              Submission Status Date
              2014-07-03 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            8. Appl No
              014901
              Review Priority
              UNKNOWN
              Submission Class Code ID
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              Submission No
              39
              Submission Status
              AP
              Submission Status Date
              2011-07-15 00:00:00
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              Submissions Public Notes
            9. Appl No
              014901
              Review Priority
              UNKNOWN
              Submission Class Code ID
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              Submission No
              38
              Submission Status
              AP
              Submission Status Date
              2011-06-16 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            10. Appl No
              014901
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              37
              Submission Status
              AP
              Submission Status Date
              2010-01-28 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            11. Appl No
              014901
              Review Priority
              STANDARD
              Submission Class Code ID
              4
              Submission No
              35
              Submission Status
              AP
              Submission Status Date
              2001-01-05 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            12. Appl No
              014901
              Review Priority
              STANDARD
              Submission Class Code ID
              3
              Submission No
              34
              Submission Status
              AP
              Submission Status Date
              2006-11-20 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            application number
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            approval interpretation
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            current indication status
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            has approved submission record
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            latest approved submission date
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            1. Appl No
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              Application Docs Date
              2024-11-18 00:00:00
              Application Docs ID
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              Application Docs Title
              0
              Application Docs Type ID
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              Submission No
              55
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            Appl No
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            Sponsor Name
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            openfda application present
            true
            products
            1. Active Ingredient
              TRIAMCINOLONE ACETONIDE
              Appl No
              014901
              Drug Name
              KENALOG-40
              Form
              INJECTABLE;INJECTION
              Product No
              001
              Reference Drug
              1
              Reference Standard
              1
              Strength
              40MG/ML
              marketing status
              1. Prescription
            2. Active Ingredient
              TRIAMCINOLONE ACETONIDE
              Appl No
              014901
              Drug Name
              KENALOG-80
              Form
              INJECTABLE;INJECTION
              Product No
              002
              Reference Drug
              1
              Reference Standard
              1
              Strength
              80MG/ML
              marketing status
              1. Prescription

          Source passages and status connections

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

          Passage 1 · indication intro context
          application numbers
          1. NDA014901
          brand names
          1. KENALOG-40
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          INDICATIONS AND USAGE Intramuscular Where oral therapy is not feasible, injectable corticosteroid therapy, including Kenalog-40 Injection (triamcinolone acetonide injectable suspension, USP) are indicated for intramuscular use 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, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or
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                INDICATIONS AND USAGE Intramuscular Where oral therapy is not feasible, injectable corticosteroid therapy, including Kenalog-40 Injection (triamcinolone acetonide injectable suspension, USP) are indicated for intramuscular use 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, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions.
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                ate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, 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
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                      Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome).
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                      ickness, 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 and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, Diamo
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                                                                    ar 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
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                                                                          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. Intra-Articular The intra-articular or soft tissue administration of Kenalog-40 Injection are indicated as adjunc
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                                                                                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).
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                                                                                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. Intra-Articular The intra-articular or soft tissue administration of Kenalog-40 Injection are indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode
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                                                                                      For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.
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                                                                                      oid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus. Intra-Articular The intra-articular or soft tissue administration of Kenalog-40 Injection are 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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                                                                                            Preserved source evidence · Not medical advice