FDA Orange Book · active-ingredient family
Leuprolide acetate; norethindrone acetate
Leuprolide acetate; norethindrone acetate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:LUPANETA PACK · NDA 203696
1
Brand (NDA)
0
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LUPANETA PACKRLD×2 | ABBVIE ENDOCRINE | NDA 203696 | — | Dec 14, 2012 |
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.
Leuprolide acetate; norethindrone acetate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
