Treats active duodenal ulcer. ANDA 75591, held by Baxter Hlthcare. Famotidine.
As of Nov 15, 2026, ANDA 75591 (Famotidine Preservative Free In Plastic Container), held by Baxter Hlthcare, was first approved by FDA on May 10, 2001, with 3 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Famotidine Injection is supplied as a premixed solution in GALAXY plastic containers and 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 |
|---|---|---|---|
| May 10, 2001 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Famotidine Preservative Free In Plastic Container0.4MG/ML · injectable;injection | Famotidine | Rx |
| Aug 20, 2024 | Supplement 12Labeling · Standard review | Approved | None posted |
| Apr 6, 2015 | Supplement 7Labeling · Standard review | Approved | None posted |
| Jan 6, 2011 | Supplement 3Labeling | Approved | None posted |
| May 10, 2001 | Original application | Approved |
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
