ANDA 74424, held by Ivax Sub Teva Pharms. Cimetidine.
As of Nov 14, 2026, ANDA 74424 (Cimetidine), held by Ivax Sub Teva Pharms, was first approved by FDA on Jul 28, 1995, with 14 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 28, 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 |
| Mar 22, 2007 | Supplement 20Labeling | Approved | None posted |
| Jul 29, 2002 | Supplement 15Manufacturing | Approved | None posted |
| Mar 12, 2002 | Supplement 14Manufacturing | Approved | None posted |
| Jan 28, 2000 | Supplement 12Manufacturing | Approved | None posted |
| Jul 8, 1999 | Supplement 11Manufacturing | Approved | None posted |
| Mar 12, 1999 | Supplement 10Manufacturing | Approved | None posted |
| May 26, 1998 | Supplement 9Labeling | Approved | None posted |
| Dec 17, 1996 | Supplement 8Manufacturing | Approved | None posted |
| Dec 17, 1996 | Supplement 7Labeling | Approved | None posted |
| Dec 17, 1996 | Supplement 6Manufacturing | Approved | None posted |
| Dec 17, 1996 | Supplement 4Manufacturing | Approved | None posted |
| Dec 17, 1996 | Supplement 3Manufacturing | Approved | None posted |
| Dec 17, 1996 | Supplement 2Manufacturing | Approved | None posted |
| Feb 13, 1996 | Supplement 1Manufacturing | Approved | None posted |
| Jul 28, 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
