ANDA 216030, held by Ascent Pharms Inc. Famotidine.
As of Nov 15, 2026, ANDA 216030 (Famotidine), held by Ascent Pharms Inc, was first approved by FDA on Nov 3, 2021, 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 |
|---|---|---|---|
| Nov 3, 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
