ANDA 218003, held by Contract Pharmacal. Famotidine.
As of Nov 15, 2026, ANDA 218003 (Famotidine), held by Contract Pharmacal, was first approved by FDA on May 28, 2024, 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 |
|---|---|---|---|
| May 28, 2024 | 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
