ANDA 90095, held by Barr. Dutasteride.
As of Nov 15, 2026, ANDA 90095 (Dutasteride), held by Barr, was first approved by FDA on Dec 21, 2010, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 21, 2010 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dutasteride0.5MG · capsule;oral | Dutasteride | Rx |
| May 14, 2015 | Supplement 2Labeling · Standard review | Approved | None posted |
| Dec 21, 2010 | Original application | Approved |
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
