ANDA 211732, held by Hetero Labs Ltd Iii. Omeprazole Magnesium.
As of Nov 15, 2026, ANDA 211732 (Omeprazole Magnesium), held by Hetero Labs Ltd Iii, was first approved by FDA on Mar 25, 2020, with 0 approved supplements and 0 published complete response letters.
Use(s)
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 25, 2020 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Omeprazole MagnesiumEQ 20MG BASE · tablet, delayed release;oral | Omeprazole Magnesium | OTC |
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
