Controls severe or incapacitating allergic conditions. ANDA 212567, held by Mylan Labs Ltd. Triamcinolone Acetonide.
As of Nov 15, 2026, ANDA 212567 (Triamcinolone Acetonide), held by Mylan Labs Ltd, was first approved by FDA on Nov 2, 2022, 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, USP 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 |
|---|---|---|---|
| Nov 2, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Triamcinolone Acetonide40MG/ML · injectable;injection | Triamcinolone Acetonide | Rx |
| Apr 3, 2025 | Supplement 4Labeling · Standard review | Approved | None posted |
| Nov 2, 2022 | Original application | 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
