ANDA 206342, held by Puracap Labs Blu. Phentermine Hydrochloride.
As of Nov 15, 2026, ANDA 206342 (Phentermine Hydrochloride), held by Puracap Labs Blu, was first approved by FDA on Nov 18, 2016, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 18, 2016 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Phentermine Hydrochloride37.5MG · tablet;oral | Phentermine Hydrochloride | Rx |
| May 31, 2017 | Supplement 1Labeling · Standard review | Approved | None posted |
| Nov 18, 2016 | 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
