ANDA 218035, held by Dr Reddys. Prednisone.
As of Nov 14, 2026, ANDA 218035 (Prednisone), held by Dr Reddys, was first approved by FDA on Jun 26, 2026, 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 |
|---|---|---|---|
| Jun 26, 2026 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Prednisone5MG · 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
