Orange Book product · Generic (ANDA)
GLYBURIDE AND METFORMIN HYDROCHLORIDE
GLYBURIDE; METFORMIN HYDROCHLORIDE
At a glance
Jun 28, 2005
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 28, 2005
21 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
GLYBURIDE; METFORMIN HYDROCHLORIDE
Strength
1.25MG;250MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 076716
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of GLYBURIDE; METFORMIN HYDROCHLORIDE
- 2000GLUCOVANCEBrand (NDA)
NDA 021178 · BRISTOL MYERS SQUIBB
- 2016GLYBURIDE AND METFORMIN HYDROCHLORIDEGeneric (ANDA)
ANDA 206748 · ZYDUS PHARMS
- 2009GLYBURIDE AND METFORMIN HYDROCHLORIDEGeneric (ANDA)
ANDA 079009 · HERITAGE
- 2007GLYBURIDE AND METFORMIN HYDROCHLORIDEGeneric (ANDA)
ANDA 077870 · AUROBINDO PHARMA
- 2005GLYBURIDE AND METFORMIN HYDROCHLORIDEGeneric (ANDA)
ANDA 076821 · TEVA
- 2004GLYBURIDE AND METFORMIN HYDROCHLORIDEGeneric (ANDA)
ANDA 076731 · IMPAX LABS INC
- 2004GLYBURIDE AND METFORMIN HYDROCHLORIDEGeneric (ANDA)
ANDA 076345 · IMPAX
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.
