ANDA 91252, held by Am Regent. Nandrolone Decanoate.
As of Nov 15, 2026, ANDA 91252 (Nandrolone Decanoate), held by Am Regent, was first approved by FDA on Aug 30, 2010, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 30, 2010 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nandrolone Decanoate200MG/ML ยท injectable;injection | Nandrolone Decanoate | 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
