ANDA 74869, held by Actavis Elizabeth. Clonazepam.
As of Nov 14, 2026, ANDA 74869 (Clonazepam), held by Actavis Elizabeth, was first approved by FDA on Oct 31, 1996, with 15 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 31, 1996 | Original application | Approved | None posted |
| Clonazepam0.5MG · tablet;oral | Clonazepam | Rx |
| Clonazepam1MG · tablet;oral | Clonazepam | Rx |
| Clonazepam2MG · tablet;oral | Clonazepam | Rx |
| Jun 12, 2024 | Supplement 37Labeling · Standard review | Approved | None posted |
| Jun 12, 2024 | Supplement 38Labeling · Standard review | Approved | None posted |
| Jun 12, 2024 | Supplement 42Labeling · Standard review | Approved | None posted |
| Jun 12, 2024 | Supplement 43Labeling · Standard review | Approved | None posted |
| Apr 3, 2013 | Supplement 29Labeling | Approved | None posted |
| Apr 8, 2011 | Supplement 27Labeling | Approved | None posted |
| Oct 15, 2009 | Supplement 25Labeling | Approved | None posted |
| Nov 2, 2001 | Supplement 7Manufacturing | Approved | None posted |
| Oct 5, 2001 | Supplement 8Labeling | Approved | None posted |
| Apr 27, 2001 | Supplement 6Manufacturing | Approved | None posted |
| Aug 25, 2000 | Supplement 5Labeling | Approved | None posted |
| Mar 12, 1999 | Supplement 4Manufacturing | Approved | None posted |
| Nov 24, 1998 | Supplement 3Manufacturing | Approved | None posted |
| Nov 10, 1997 | Supplement 2Labeling | Approved | None posted |
| May 23, 1997 | Supplement 1Manufacturing | Approved | None posted |
| Oct 31, 1996 | 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
