ANDA 91315, held by Dr Reddys Labs Ltd. Mycophenolate Mofetil.
As of Nov 14, 2026, ANDA 91315 (Mycophenolate Mofetil), held by Dr Reddys Labs Ltd, was first approved by FDA on Oct 27, 2011, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 27, 2011 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Mycophenolate Mofetil250MG ยท capsule;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
