ANDA 88317, held by Abraxis Pharm. Nandrolone Decanoate.
As of Nov 15, 2026, ANDA 88317 (Nandrolone Decanoate), held by Abraxis Pharm, was first approved by FDA on Oct 14, 1983, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 14, 1983 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nandrolone Decanoate200MG/ML ยท injectable;injection | Nandrolone Decanoate | Discontinued |
| Feb 4, 1991 | Supplement 14Labeling | Approved | None posted |
| Feb 18, 1988 | Supplement 10Labeling | Approved | None posted |
| Oct 14, 1983 | 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
