ANDA 202808, held by Actavis Labs Fl Inc. Dutasteride.
As of Nov 15, 2026, ANDA 202808 (Dutasteride), held by Actavis Labs Fl Inc, 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
