ANDA 207740, held by Dr Reddys. Omeprazole.
As of Nov 15, 2026, ANDA 207740 (Omeprazole), held by Dr Reddys, was first approved by FDA on Nov 5, 2018, with 1 approved supplement and 0 published complete response letters.
Use(s) treats frequent heartburn (occurs 2 or more days a week) not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 5, 2018 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Omeprazole20MG · tablet, delayed release;oral | Omeprazole | OTC |
| Apr 29, 2026 | Supplement 9Manufacturing | Approved | None posted |
| Nov 5, 2018 | Original application | Approved |
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
