FDA Orange Book · active-ingredient family
Glimepiride; rosiglitazone maleate
Glimepiride; 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:AVANDARYL · NDA 021700
1
Brand (NDA)
1
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AVANDARYLRLD×5 | SB PHARMCO | NDA 021700 | — | Nov 23, 2005 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ROSIGLITAZONE MALEATE AND GLIMEPIRIDE×5 | TEVA PHARMS USA | ANDA 078709 | — | Apr 01, 2016 |
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.
Glimepiride; rosiglitazone maleate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
