ANDA 74100, held by Chartwell Rx. Cimetidine.
As of Nov 14, 2026, ANDA 74100 (Cimetidine), held by Chartwell Rx, was first approved by FDA on Jan 31, 1995, with 16 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 31, 1995 | Original application | Approved | None posted |
| Cimetidine200MG · tablet;oral | Cimetidine | Discontinued |
| Cimetidine300MG · tablet;oral | Cimetidine | Discontinued |
| Cimetidine400MG · tablet;oral | Cimetidine | Discontinued |
| Cimetidine800MG · tablet;oral | Cimetidine | Discontinued |
| Apr 19, 2002 | Supplement 18Manufacturing | Approved | None posted |
| Dec 13, 2001 | Supplement 12Manufacturing | Approved | None posted |
| Dec 13, 2001 | Supplement 13Manufacturing | Approved | None posted |
| Dec 13, 2001 | Supplement 14Labeling | Approved | None posted |
| Dec 13, 2001 | Supplement 15Manufacturing | Approved | None posted |
| Jul 5, 2001 | Supplement 10Manufacturing | Approved | None posted |
| May 9, 2001 | Supplement 17Manufacturing | Approved | None posted |
| Apr 4, 2001 | Supplement 11Manufacturing | Approved | None posted |
| Nov 28, 2000 | Supplement 9Manufacturing | Approved | None posted |
| Jun 29, 2000 | Supplement 8Manufacturing | Approved | None posted |
| May 4, 1999 | Supplement 4Manufacturing | Approved | None posted |
| May 4, 1999 | Supplement 5Labeling | Approved | None posted |
| Jan 14, 1999 | Supplement 6Manufacturing | Approved | None posted |
| Sep 24, 1997 | Supplement 3Manufacturing | Approved | None posted |
| Aug 19, 1996 | Supplement 1Manufacturing | Approved | None posted |
| Aug 19, 1996 | Supplement 2Manufacturing | Approved | None posted |
| Jan 31, 1995 | 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
