ANDA 203241, held by Pharmobedient. Dutasteride.
As of Nov 15, 2026, ANDA 203241 (Dutasteride), held by Pharmobedient, was first approved by FDA on Jun 14, 2016, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 14, 2016 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dutasteride0.5MG · capsule;oral | Dutasteride | Discontinued |
| Oct 24, 2024 | Supplement 4Labeling · Standard review | Approved | None posted |
| Jun 14, 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
