ANDA 40276, held by Actavis Elizabeth. Phentermine Hydrochloride.
As of Nov 15, 2026, ANDA 40276 (Phentermine Hydrochloride), held by Actavis Elizabeth, was first approved by FDA on Nov 25, 1998, with 4 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 25, 1998 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Phentermine Hydrochloride37.5MG · tablet;oral | Phentermine Hydrochloride | Discontinued |
| May 31, 2017 | Supplement 16Labeling · Standard review | Approved | None posted |
| Nov 4, 2015 | Supplement 15Labeling · Standard review | Approved | None posted |
| Nov 2, 2001 | Supplement 2Manufacturing | Approved | None posted |
| Apr 4, 2001 | Supplement 1Manufacturing | Approved | None posted |
| Nov 25, 1998 | 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
