Treats active duodenal ulcer. ANDA 75742, held by Dr Reddys Labs Ltd. Ranitidine Hydrochloride.
As of Nov 15, 2026, ANDA 75742 (Ranitidine Hydrochloride), held by Dr Reddys Labs Ltd, was first approved by FDA on Nov 29, 2000, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Ranitidine is indicated in: 1. 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. 2. 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. 3.The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis). 4. Short-term treatment of active, benign gastric ulcer.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 29, 2000 | Original application | Approved |
| Ranitidine HydrochlorideEQ 150MG BASE · capsule;oral | Ranitidine Hydrochloride | Rx |
| Ranitidine HydrochlorideEQ 300MG BASE · capsule;oral | Ranitidine Hydrochloride | Rx |
| Apr 18, 2001 | Supplement 1Manufacturing | Approved | None posted |
| Nov 29, 2000 | 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
