ANDA 90464, held by Dr Reddys Labs Ltd. Mycophenolate Mofetil.
As of Nov 14, 2026, ANDA 90464 (Mycophenolate Mofetil), held by Dr Reddys Labs Ltd, was first approved by FDA on Sep 13, 2010, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 13, 2010 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Mycophenolate Mofetil500MG ยท tablet;oral | Mycophenolate Mofetil | Discontinued |
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
