ANDA 70894, held by Duramed Pharms Barr. Diazepam.
As of Nov 13, 2026, ANDA 70894 (Diazepam), held by Duramed Pharms Barr, was first approved by FDA on Aug 27, 1986, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 27, 1986 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Diazepam2MG ยท tablet;oral | Diazepam | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 10, 1989 | Supplement 4Labeling | Approved | None posted |
| Aug 19, 1988 | Supplement 3Labeling | Approved | None posted |
| Aug 27, 1986 | 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
