FDA Orange Book · active-ingredient family
Oxandrolone
Oxandrolone is approved in 5 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
0
Brand (NDA)
5
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Generic (ANDA) products (5)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| OXANDROLONE×2 | ROXANE | ANDA 077249 | — | Jul 10, 2007 | |
| OXANDROLONE×2 | PAR PHARM | ANDA 077827 | — | Jun 22, 2007 | |
| OXANDROLONE | UPSHER SMITH LABS | ANDA 078033 | — | Mar 22, 2007 | |
| OXANDROLONE×2 | SANDOZ | ANDA 076897 | — | Dec 01, 2006 | |
| OXANDROLONE | UPSHER SMITH LABS | ANDA 076761 | — | Dec 01, 2006 |
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.
Oxandrolone — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
