ANDA 202421, held by Ph Health. Dutasteride.
As of Nov 15, 2026, ANDA 202421 (Dutasteride), held by Ph Health, was first approved by FDA on Nov 20, 2015, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 20, 2015 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dutasteride0.5MG ยท capsule;oral | Dutasteride | 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
