ANDA 78003, held by Cipla. Esomeprazole Magnesium.
As of Nov 15, 2026, ANDA 78003 (Esomeprazole Magnesium), held by Cipla, was first approved by FDA on Jan 26, 2015, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 26, 2015 | Original application | Approved |
| Esomeprazole MagnesiumEQ 20MG BASE · capsule, delayed rel pellets;oral | Esomeprazole Magnesium | Discontinued |
| Esomeprazole MagnesiumEQ 40MG BASE · capsule, delayed rel pellets;oral | Esomeprazole Magnesium | 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
