Treats active duodenal ulcer. ANDA 77824, held by Amneal Pharms Ny. Ranitidine Hydrochloride.
As of Nov 15, 2026, ANDA 77824 (Ranitidine Hydrochloride), held by Amneal Pharms Ny, was first approved by FDA on Oct 13, 2006, with 3 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Ranitidine Tablets, USP are indicated in: Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative studies have been carried out for periods of longer than 1 year. The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis). Short-term treatment of active, benign gastric ulcer.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 13, 2006 | Original application | Approved | None posted |
| Ranitidine HydrochlorideEQ 150MG BASE · tablet;oral | Ranitidine Hydrochloride | Discontinued |
| Ranitidine HydrochlorideEQ 300MG BASE · tablet;oral | Ranitidine Hydrochloride | Discontinued |
| Feb 7, 2017 | Supplement 16Manufacturing | Approved | None posted |
| Apr 30, 2010 | Supplement 5Labeling | Approved | None posted |
| Mar 20, 2008 | Supplement 1Manufacturing | Approved | None posted |
| Oct 13, 2006 | 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
