ANDA 76322, held by Epic Pharma LLC. Famotidine.
As of Nov 15, 2026, ANDA 76322 (Famotidine Preservative Free (Pharmacy Bulk)), held by Epic Pharma LLC, was first approved by FDA on Nov 27, 2002, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 27, 2002 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Famotidine Preservative Free (Pharmacy Bulk)10MG/ML · injectable;injection | Famotidine | Discontinued |
| Sep 25, 2020 | Supplement 11Labeling · Standard review | Approved | None posted |
| Nov 27, 2002 | 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
