ANDA 218344, held by Epic Pharma LLC. Famotidine.
As of Nov 15, 2026, ANDA 218344 (Famotidine), held by Epic Pharma LLC, was first approved by FDA on Oct 16, 2024, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 16, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Famotidine40MG/5ML ยท for suspension;oral | Famotidine | Rx |
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
