ANDA 218773, held by Dr Reddys. Triamcinolone Acetonide.
As of Nov 15, 2026, ANDA 218773 (Triamcinolone Acetonide), held by Dr Reddys, was first approved by FDA on Mar 12, 2025, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE The intra-articular or soft tissue administration of triamcinolone acetonide injectable suspension 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 12, 2025 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Triamcinolone Acetonide10MG/ML · injectable;injection | Triamcinolone Acetonide | Rx |
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
