Treats active duodenal ulcer. ANDA 74329, held by Chartwell Molecules. Cimetidine.
As of Nov 14, 2026, ANDA 74329 (Cimetidine), held by Chartwell Molecules, was first approved by FDA on May 17, 1994, with 6 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 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 |
|---|---|---|---|
| May 17, 1994 | Original application | Approved | None posted |
| Cimetidine800MG · tablet;oral | Cimetidine | Rx |
| Cimetidine200MG · tablet;oral | Cimetidine | Rx |
| Cimetidine300MG · tablet;oral | Cimetidine | Rx |
| Cimetidine400MG · tablet;oral | Cimetidine | Rx |
| Jul 23, 1999 | Supplement 5Manufacturing | Approved | None posted |
| Jul 23, 1999 | Supplement 6Manufacturing | Approved | None posted |
| May 8, 1996 | Supplement 4Labeling | Approved | None posted |
| Feb 17, 1995 | Supplement 3Manufacturing | Approved | None posted |
| Dec 19, 1994 | Supplement 1Manufacturing | Approved | None posted |
| Dec 19, 1994 | Supplement 2Manufacturing | Approved | None posted |
| May 17, 1994 | 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
