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LABELS · c31f11c2-b581-4f75-b0b4-9b97e80ff68e

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
2026-07-30
Captured
2026-09-09T23:37:58.719708+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=653ec195-0966-478d-be47-6b1ff158e111
    generic names
    1. TRIAMCINOLONE ACETONIDE
    id
    c31f11c2-b581-4f75-b0b4-9b97e80ff68e
    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
        manufacturer names
        1. A-S Medication Solutions
        matched search terms
        1. tumors
        package ndcs
        1. 50090-0295-1
        product ndcs
        1. 50090-0295
        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
          results
          limit
          100
          skip
          600
          total
          830
          sha256
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          url
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          source url
          https://api.fda.gov/drug/label.json?search=id%3A%22c31f11c2-b581-4f75-b0b4-9b97e80ff68e%22
          spl effective date
          2026-07-30
          spl effective time
          20260730
          spl set id
          653ec195-0966-478d-be47-6b1ff158e111
          spl version
          20
          substance names
          1. TRIAMCINOLONE ACETONIDE
          uniis
          1. F446C597KA
          verification flags
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          2. spl_text_not_verified_identical_to_latest_approved_label
          3. individual_indications_not_split_or_reconciled
          4. not_identified_as_original_packager
          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
              2
              Submission No
              52
              Submission Type
              SUPPL
            official application record
            Appl No
            012041
            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
          end
          627
          end exclusive
          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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          duplicate text group
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          generic names
          1. TRIAMCINOLONE ACETONIDE
          id
          ind-span-44e4b576c45fc5b4628e
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          qualifier mentions
            regulatory links
              schema version
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                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.
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                spl set id
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                structured fields status
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                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 2 · positive indication candidate
                application numbers
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                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. 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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                      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
                      tumor_directed_candidate

                      Preserved source evidence · Not medical advice