Controls severe or incapacitating allergic conditions. ANDA 207550, held by Amneal. Triamcinolone Acetonide.
As of Nov 15, 2026, ANDA 207550 (Triamcinolone Acetonide), held by Amneal, was first approved by FDA on Dec 11, 2017, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Intramuscular Where oral therapy is not feasible, injectable corticosteroid therapy, including triamcinolone acetonide injectable suspension is 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 |
|---|---|---|---|
| Dec 11, 2017 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Triamcinolone Acetonide40MG/ML · injectable;injection | Triamcinolone Acetonide | Rx |
| Oct 3, 2019 | Supplement 3Labeling · Standard review | Approved | None posted |
| Dec 11, 2017 | Original application | Approved |
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
