Treats active duodenal ulcer. ANDA 75616, held by Watson Labs. Nizatidine.
As of Nov 15, 2026, ANDA 75616 (Nizatidine), held by Watson Labs, was first approved by FDA on Jul 9, 2002, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Nizatidine is indicated for up to 8 weeks for the treatment of active duodenal ulcer. In most patients, the ulcer will heal within 4 weeks. Nizatidine is indicated for maintenance therapy for duodenal ulcer patients, at a reduced dosage of 150 mg h.s. after healing of an active duodenal ulcer. The consequences of continuous therapy with nizatidine for longer than 1 year are not known. Nizatidine is indicated for up to 12 weeks for the treatment of endoscopically diagnosed esophagitis, including erosive and ulcerative esophagitis, and associated heartburn due to GERD. Nizatidine is
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 9, 2002 | Original application | Approved |
| Nizatidine150MG · capsule;oral | Nizatidine | Rx |
| Nizatidine300MG · capsule;oral | Nizatidine | 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
