FDA Orange Book · active-ingredient family
Metformin hydrochloride; rosiglitazone maleate
Metformin hydrochloride; rosiglitazone maleate is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:AVANDAMET · NDA 021410
1
Brand (NDA)
1
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AVANDAMETRLD×5 | SB PHARMCO | NDA 021410 | — | Aug 25, 2003 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE×5 | TEVA | ANDA 077337 | — | May 07, 2014 |
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.
Metformin hydrochloride; rosiglitazone maleate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
