Treats active duodenal ulcer. ANDA 218220, held by Bionpharma. Cimetidine.
As of Nov 14, 2026, ANDA 218220 (Cimetidine), held by Bionpharma, was first approved by FDA on Nov 7, 2024, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Cimetidine tablets are indicated in: 1. Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks and there is rarely reason to use cimetidine tablets at full dosage for longer than 6 weeks to 8 weeks (see DOSAGE AND ADMINISTRATION: Duodenal Ulcer ). Concomitant antacids should be given as needed for relief of pain. However, simultaneous administration of cimetidine tablets and antacids is not recommended, since antacids have been reported to interfere with the absorption of cimetidine. 2. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of active ulcer.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 7, 2024 | Original application | Approved | None posted |
| Cimetidine200MG · tablet;oral | Cimetidine | Rx |
| Cimetidine300MG · tablet;oral | Cimetidine | Rx |
| Cimetidine400MG · tablet;oral | Cimetidine | Rx |
| Cimetidine800MG · tablet;oral | Cimetidine | 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
