ANDA 40790, held by Sun Pharm Inds Inc. Phentermine Hydrochloride.
As of Nov 15, 2026, ANDA 40790 (Phentermine Hydrochloride), held by Sun Pharm Inds Inc, was first approved by FDA on Aug 21, 2007, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 21, 2007 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Phentermine Hydrochloride37.5MG · tablet;oral | Phentermine Hydrochloride | Discontinued |
| May 31, 2017 | Supplement 7Labeling · Standard review | Approved | None posted |
| Dec 6, 2012 | Supplement 6Labeling · Standard review | Approved | None posted |
| Aug 21, 2007 | 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
