Orange Book product · Brand (NDA)
METAGLIP
GLIPIZIDE; METFORMIN HYDROCHLORIDE
At a glance
Oct 21, 2002
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 21, 2002
24 yr ago
Today
Pharmaceutical detail
Active ingredient
GLIPIZIDE; METFORMIN HYDROCHLORIDE
Strength
2.5MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 021460
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.
- 2011GLIPIZIDE AND METFORMIN HYDROCHLORIDEGeneric (ANDA)
ANDA 078905 · ZYDUS PHARMS USA INC
- 2010GLIPIZIDE AND METFORMIN HYDROCHLORIDEGeneric (ANDA)
ANDA 078728 · HERITAGE
- 2008GLIPIZIDE AND METFORMIN HYDROCHLORIDEGeneric (ANDA)
ANDA 077620 · SUN PHARM INDS INC
- 2007GLIPIZIDE AND METFORMIN HYDROCHLORIDEGeneric (ANDA)
ANDA 078083 · NOVITIUM PHARMA
- 2005GLIPIZIDE AND METFORMIN HYDROCHLORIDEGeneric (ANDA)
ANDA 077270 · TEVA PHARMS
- 2005GLIPIZIDE AND METFORMIN HYDROCHLORIDEGeneric (ANDA)
ANDA 077507 · EPIC PHARMA LLC
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.
