ANDA 77749, held by Strides Pharma Intl. Diazepam.
As of Nov 13, 2026, ANDA 77749 (Diazepam), held by Strides Pharma Intl, was first approved by FDA on Mar 31, 2006, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 31, 2006 | Original application | Approved | None posted |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 1, 2015 | Supplement 6Labeling · Standard review | Approved | None posted |
| Jan 14, 2009 | Supplement 1Labeling | Approved | None posted |
| Mar 31, 2006 | Original application | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
