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LABELS · 869689dc-4bf0-4665-9e64-a603bf2ddf62

KENALOG-10

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
2024-08-26
Captured
2026-09-09T23:37:54.830918+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. INDICATIONS AND USAGE The intra-articular or soft tissue administration of KENALOG-10 Injection (triamcinolone acetonide injectable suspension, USP) 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. The intralesional administration of KENALOG-10 Injection is indicated for 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.KENALOG-10 Injection may also be useful in cystic tumors of an aponeurosis or tendon (ganglia).
Full extracted label fields
application numbers
  1. NDA012041
boxed warning exact
    brand names
    1. KENALOG-10
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ec04ecbb-2896-3feb-85fd-a64aba93b289
    generic names
    1. TRIAMCINOLONE ACETONIDE
    id
    869689dc-4bf0-4665-9e64-a603bf2ddf62
    indications and usage exact
    1. INDICATIONS AND USAGE The intra-articular or soft tissue administration of KENALOG-10 Injection (triamcinolone acetonide injectable suspension, USP) 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. The intralesional administration of KENALOG-10 Injection is indicated for 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.KENALOG-10 Injection may also be useful in cystic tumors of an aponeurosis or tendon (ganglia).
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. E.R. Squibb & Sons, L.L.C.
      matched search terms
      1. tumors
      package ndcs
      1. 0003-0494-20
      product ndcs
      1. 0003-0494
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. INTRA-ARTICULAR
        2. INTRALESIONAL
        rxcuis
        1. 1085750
        2. 1085752
        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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        limit
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        skip
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        total
        830
        sha256
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        url
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        source url
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        spl effective date
        2024-08-26
        spl effective time
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        substance names
        1. TRIAMCINOLONE ACETONIDE
        uniis
        1. F446C597KA
        verification flags
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        Drugs@FDA application source records
        1. application number
          NDA012041
          payload
          all indexed label documents
          1. Appl No
            012041
            Application Docs Date
            2011-06-16 00:00:00
            Application Docs ID
            10791
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            38
            Submission Type
            SUPPL
          2. Appl No
            012041
            Application Docs Date
            2006-11-22 00:00:00
            Application Docs ID
            33068
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            33
            Submission Type
            SUPPL
          3. Appl No
            012041
            Application Docs Date
            2010-02-04 00:00:00
            Application Docs ID
            33069
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            36
            Submission Type
            SUPPL
          4. Appl No
            012041
            Application Docs Date
            2011-07-18 00:00:00
            Application Docs ID
            33070
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            39
            Submission Type
            SUPPL
          5. Appl No
            012041
            Application Docs Date
            2014-07-09 00:00:00
            Application Docs ID
            33071
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            42
            Submission Type
            SUPPL
          6. Appl No
            012041
            Application Docs Date
            2018-04-01 00:00:00
            Application Docs ID
            53572
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            44
            Submission Type
            SUPPL
          7. Appl No
            012041
            Application Docs Date
            2018-06-29 00:00:00
            Application Docs ID
            54731
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            45
            Submission Type
            SUPPL
          8. Appl No
            012041
            Application Docs Date
            2024-06-06 00:00:00
            Application Docs ID
            78676
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            51
            Submission Type
            SUPPL
          9. Appl No
            012041
            Application Docs Date
            2024-09-24 00:00:00
            Application Docs ID
            79707
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            52
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            012041
            Review Priority
            N/A
            Submission Class Code ID
            4
            Submission No
            52
            Submission Status
            AP
            Submission Status Date
            2024-08-14 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          2. Appl No
            012041
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            51
            Submission Status
            AP
            Submission Status Date
            2024-06-05 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            012041
            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
          4. Appl No
            012041
            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
          5. Appl No
            012041
            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
          6. Appl No
            012041
            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
          7. Appl No
            012041
            Review Priority
            UNKNOWN
            Submission Class Code ID
            3
            Submission No
            39
            Submission Status
            AP
            Submission Status Date
            2011-07-15 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          8. Appl No
            012041
            Review Priority
            UNKNOWN
            Submission Class Code ID
            3
            Submission No
            38
            Submission Status
            AP
            Submission Status Date
            2011-06-16 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          9. Appl No
            012041
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            36
            Submission Status
            AP
            Submission Status Date
            2010-01-28 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          10. Appl No
            012041
            Review Priority
            STANDARD
            Submission Class Code ID
            4
            Submission No
            34
            Submission Status
            AP
            Submission Status Date
            2001-06-15 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          11. Appl No
            012041
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            33
            Submission Status
            AP
            Submission Status Date
            2006-11-20 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          12. Appl No
            012041
            Review Priority
            STANDARD
            Submission Class Code ID
            4
            Submission No
            32
            Submission Status
            AP
            Submission Status Date
            1998-02-03 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA012041
          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
          2024-08-14
          latest label selection rule
          max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
          latest posted label documents
          1. Appl No
            012041
            Application Docs Date
            2024-09-24 00:00:00
            Application Docs ID
            79707
            Application Docs Title
            0
            Application Docs Type ID
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            Submission No
            52
            Submission Type
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          official application record
          Appl No
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          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          APOTHECON
          openfda application present
          true
          products
          1. Active Ingredient
            TRIAMCINOLONE ACETONIDE
            Appl No
            012041
            Drug Name
            KENALOG-10
            Form
            INJECTABLE;INJECTION
            Product No
            001
            Reference Drug
            1
            Reference Standard
            0
            Strength
            10MG/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 · positive indication candidate
        application numbers
        1. NDA012041
        brand names
        1. KENALOG-10
        classification reasons
        1. explicit_positive_indication_predicate
        2. no_tumor_directed_keyword_in_positive_statement
        clinical review status
        pending
        content role
        positive_indication_candidate
        context span
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        627
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        true
        exact text
        INDICATIONS AND USAGE The intra-articular or soft tissue administration of KENALOG-10 Injection (triamcinolone acetonide injectable suspension, USP) 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. The intralesional administration of KENALOG-10 Injection is indicated for alopecia areata; discoid lupus erythematosus; keloids; localized hypertrophic, infiltrated, inflammatory lesions of granuloma
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              INDICATIONS AND USAGE The intra-articular or soft tissue administration of KENALOG-10 Injection (triamcinolone acetonide injectable suspension, USP) 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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              Source null
              approval pathway
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              biomarker and test
              Source null
              disease stage
              Source null
              limitations
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              tumor histology
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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. The intralesional administration of KENALOG-10 Injection is indicated for 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.KENALOG-10 Injection may also be useful in cystic tumors of an aponeurosis or tendon (ganglia).
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                    The intralesional administration of KENALOG-10 Injection is indicated for 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.KENALOG-10 Injection may also be useful in cystic tumors of an aponeurosis or tendon (ganglia).
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                    limitations
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                    use intent
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                    Preserved source evidence · Not medical advice