ANDA 215766, held by Annora Pharma. Famotidine.
As of Nov 15, 2026, ANDA 215766 (Famotidine), held by Annora Pharma, was first approved by FDA on Nov 8, 2021, with 0 approved supplements and 0 published complete response letters.
relieves heartburn associated with acid indigestion and sour stomach prevents heartburn associated with acid indigestion and sour stomach brough on by eating or drinking certain food and beverages
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 8, 2021 | 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