ANDA 219477, held by Dr Reddys. Prednisone.
As of Nov 14, 2026, ANDA 219477 (Prednisone), held by Dr Reddys, was first approved by FDA on Oct 1, 2025, with 0 approved supplements and 0 published complete response letters.
Prednisone delayed-release tablets are indicated in the treatment of the following diseases or conditions: Prednisone delayed-release tablets are a corticosteroid indicated as an anti-inflammatory or immunosuppressive agent for certain allergic, dermatologic, gastrointestinal, hematologic, ophthalmologic, nervous system, renal, respiratory, rheumatologic, specific infectious diseases or conditions and organ transplantation for the treatment of certain endocrine conditions for palliation of certain neoplastic conditions 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 1, 2025 | Original application | Approved | None posted |
| Prednisone1MG · tablet, delayed release;oral | Prednisone | Rx |
| Prednisone2MG · tablet, delayed release;oral | Prednisone | 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
