Orange Book product · Generic (ANDA)
ROSIGLITAZONE MALEATE AND GLIMEPIRIDE
GLIMEPIRIDE; ROSIGLITAZONE MALEATE
Generic (ANDA)ANDA 078709DISCN TEVA PHARMS USA
At a glance
Apr 01, 2016
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 01, 2016
10 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
GLIMEPIRIDE; ROSIGLITAZONE MALEATE
Strength
1MG;4MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 078709
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of GLIMEPIRIDE; ROSIGLITAZONE MALEATE
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.
