ANDA 74250, held by Sandoz. Cimetidine.
As of Nov 14, 2026, ANDA 74250 (Cimetidine), held by Sandoz, was first approved by FDA on Jun 29, 1995, with 16 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 29, 1995 | Original application | Approved |
| Cimetidine200MG · tablet;oral | Cimetidine | Discontinued |
| Cimetidine300MG · tablet;oral | Cimetidine | Discontinued |
| Cimetidine400MG · tablet;oral | Cimetidine | Discontinued |
| Cimetidine800MG · tablet;oral | Cimetidine | Discontinued |
| Nov 13, 2002 | Supplement 16Manufacturing | Approved | None posted |
| Nov 17, 2000 | Supplement 14Manufacturing | Approved | None posted |
| Nov 17, 2000 | Supplement 15Labeling | Approved | None posted |
| May 1, 2000 | Supplement 13Manufacturing | Approved | None posted |
| Nov 5, 1998 | Supplement 8Labeling | Approved | None posted |
| Nov 5, 1998 | Supplement 9Manufacturing | Approved | None posted |
| Nov 5, 1998 | Supplement 10Manufacturing | Approved | None posted |
| Nov 5, 1998 | Supplement 11Manufacturing | Approved | None posted |
| Mar 25, 1998 | Supplement 12Labeling | Approved | None posted |
| Feb 10, 1997 | Supplement 6Manufacturing | Approved | None posted |
| Dec 9, 1996 | Supplement 4Manufacturing | Approved | None posted |
| Dec 9, 1996 | Supplement 5Labeling | Approved | None posted |
| Dec 9, 1996 | Supplement 7Manufacturing | Approved | None posted |
| Nov 4, 1996 | Supplement 3Manufacturing | Approved | None posted |
| Dec 15, 1995 | Supplement 1Manufacturing | Approved | None posted |
| Dec 15, 1995 | Supplement 2Manufacturing | Approved | None posted |
| Jun 29, 1995 | 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
