ANDA 217543, held by Pharmazone. Famotidine.
As of Nov 15, 2026, ANDA 217543 (Famotidine), held by Pharmazone, was first approved by FDA on Mar 8, 2023, with 0 approved supplements 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 |
|---|---|---|---|
| Mar 8, 2023 | Original application | Approved | None posted |
| Famotidine10MG · tablet;oral | Famotidine | OTC |
| Famotidine20MG · tablet;oral | Famotidine | 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
