FDA Orange Book · active-ingredient family
Nandrolone decanoate
Nandrolone decanoate is approved as 1 brand and 10 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DECA-DURABOLIN · NDA 013132
1
Brand (NDA)
10
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DECA-DURABOLINRLD×3 | WOODWARD SPECL | NDA 013132 | — | Jun 12, 1986 |
Generic (ANDA) products (10)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NANDROLONE DECANOATE | AM REGENT | ANDA 091252 | — | Aug 30, 2010 | |
| NANDROLONE DECANOATE | WATSON LABS | ANDA 088554 | — | Feb 10, 1986 | |
| NANDROLONE DECANOATE | WATSON LABS | ANDA 086385 | — | Jan 13, 1984 | |
| NANDROLONE DECANOATE | WATSON LABS | ANDA 086598 | — | Jan 13, 1984 | |
| NANDROLONE DECANOATERLD | WATSON LABS | ANDA 088128 | — | Dec 05, 1983 | |
| NANDROLONE DECANOATE | ABRAXIS PHARM | ANDA 088317 | — | Oct 14, 1983 | |
| NANDROLONE DECANOATE | WATSON LABS | ANDA 087598 | — | Oct 06, 1983 | |
| NANDROLONE DECANOATE | WATSON LABS | ANDA 087599 | — | Oct 06, 1983 | |
| NANDROLONE DECANOATE | ABRAXIS PHARM | ANDA 088290 | — | Oct 03, 1983 | |
| NANDROLONE DECANOATE | EPIC PHARMA LLC | ANDA 087519 | — | Sep 28, 1983 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Nandrolone decanoate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
