ANDA 65477, held by Zydus Pharms USA Inc. Mycophenolate Mofetil.
As of Nov 14, 2026, ANDA 65477 (Mycophenolate Mofetil), held by Zydus Pharms USA Inc, was first approved by FDA on May 4, 2009, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 4, 2009 | 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
