Treats active duodenal ulcer. ANDA 211289, held by Vkt Pharma. Ranitidine Hydrochloride.
As of Nov 15, 2026, ANDA 211289 (Ranitidine Hydrochloride), held by Vkt Pharma, was first approved by FDA on Jan 31, 2019, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Ranitidine Tablets 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 ulcers.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 31, 2019 | Original application | Approved | None posted |
| Ranitidine HydrochlorideEQ 150MG BASE · tablet;oral | Ranitidine Hydrochloride | Rx |
| Ranitidine HydrochlorideEQ 300MG BASE · tablet;oral | Ranitidine Hydrochloride | Rx |
| Aug 7, 2019 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Jan 31, 2019 | 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
