Treats active duodenal ulcer. ANDA 78641, held by Mylan Labs Ltd. Famotidine.
As of Nov 15, 2026, ANDA 78641 (Famotidine), held by Mylan Labs Ltd, was first approved by FDA on Jun 25, 2008, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Famotidine Injection, supplied as a concentrated solution for intravenous injection, is intended for intravenous use only. Famotidine Injection is indicated in some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or as an alternative to the oral dosage forms for short term use in patients who are unable to take oral medication for the following conditions: 1. Short term treatment of active duodenal ulcer. Most adult patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 25, 2008 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Famotidine10MG/ML · injectable;injection | Famotidine | Rx |
| Sep 15, 2020 | Supplement 12Labeling · Standard review | Approved | None posted |
| Jun 25, 2008 | 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
