ANDA 40497, held by Able. Phentermine Hydrochloride.
As of Nov 15, 2026, ANDA 40497 (Phentermine Hydrochloride), held by Able, was first approved by FDA on Mar 13, 2003, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 13, 2003 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Phentermine Hydrochloride15MG ยท capsule;oral | Phentermine Hydrochloride | Discontinued |
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
