ANDA 77367, held by Dr Reddys Labs Ltd. Famotidine.
As of Nov 15, 2026, ANDA 77367 (Famotidine), held by Dr Reddys Labs Ltd, was first approved by FDA on Sep 25, 2006, with 1 approved supplement and 0 published complete response letters.
Uses relieves heartburn associated with acid indigestion and sour stomach prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 25, 2006 | Original application | Approved | None posted |
| Famotidine20MG · tablet;oral | Famotidine | OTC |
| Famotidine10MG · tablet;oral | Famotidine | OTC |
| Nov 8, 2019 | Supplement 17Labeling · Standard review | Approved | None posted |
| Sep 25, 2006 | Original application | Approved | None posted |
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
