Controls severe or incapacitating allergic conditions. NDA 14901, held by Apothecon. Triamcinolone Acetonide.
As of Nov 14, 2026, NDA 14901 (Kenalog-40, Kenalog-80), held by Apothecon, was first approved by FDA on Feb 1, 1965, with 29 approved supplements and 0 published complete response letters.
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).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 1, 1965 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Kenalog-4040MG/ML · injectable;injection | Triamcinolone Acetonide | RxReference drug |
| Kenalog-8080MG/ML · injectable;injection | Triamcinolone Acetonide | RxReference drug |
| Aug 9, 2024 | Supplement 55Manufacturing | Approved | |
| Jun 5, 2024 | Supplement 54Labeling · Standard review | Approved | |
| Apr 12, 2019 | Supplement 47Manufacturing · Standard review | Approved | |
| Jun 22, 2018 | Supplement 45Labeling · Standard review | Approved | |
| Mar 29, 2018 | Supplement 44Labeling · Standard review | Approved | |
| Oct 26, 2015 | Supplement 43Manufacturing · Standard review | Approved | |
| Jul 3, 2014 | Supplement 42Labeling · Standard review | Approved | |
| Jul 15, 2011 | Supplement 39Labeling | Approved | |
| Jun 16, 2011 | Supplement 38Labeling | Approved | |
| Jan 28, 2010 | Supplement 37Labeling · Standard review | Approved | |
| Nov 20, 2006 | Supplement 34Labeling · Standard review | Approved | |
| Jan 5, 2001 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| May 22, 1996 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Jan 10, 1995 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Mar 28, 1994 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Feb 14, 1992 | Supplement 28Manufacturing · Standard review | Approved | |
| Jul 19, 1991 | Supplement 29Manufacturing · Standard review | Approved | |
| Nov 30, 1987 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Nov 19, 1986 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Dec 4, 1985 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Jun 14, 1985 | Supplement 25Labeling | Approved | None posted |
| Apr 13, 1984 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Jun 30, 1982 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| May 20, 1980 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Aug 21, 1979 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Jul 27, 1979 | Supplement 9Labeling | Approved | |
| Jul 17, 1979 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Apr 7, 1978 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Apr 7, 1978 | Supplement 10Labeling | Approved | |
| Feb 1, 1965 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
