Orange Book product · Generic (ANDA)
GLYBURIDE AND METFORMIN HYDROCHLORIDE
GLYBURIDE; METFORMIN HYDROCHLORIDE
At a glance
Feb 18, 2004
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 18, 2004
22 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
GLYBURIDE; METFORMIN HYDROCHLORIDE
Strength
1.25MG;250MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 076345
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)
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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 076716 · ACTAVIS ELIZABETH
- 2005GLYBURIDE AND METFORMIN HYDROCHLORIDEGeneric (ANDA)
ANDA 076821 · TEVA
- 2004GLYBURIDE AND METFORMIN HYDROCHLORIDEGeneric (ANDA)
ANDA 076731 · IMPAX LABS INC
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.
