Orange Book product · Brand (NDA)
GLUCOVANCE
GLYBURIDE; METFORMIN HYDROCHLORIDE
At a glance
Jul 31, 2000
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 31, 2000
26 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
GLYBURIDE; METFORMIN HYDROCHLORIDE
Strength
1.25MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 021178
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 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 076716 · ACTAVIS ELIZABETH
- 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.
