Orange Book product · Generic (ANDA)
GLYBURIDE
GLYBURIDE
At a glance
Jan 04, 2019
Approved
Generic (ANDA)
Application
AB1
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 04, 2019
7 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
GLYBURIDE
Strength
1.25MG
Dosage form
TABLET
Route
ORAL
TE code
AB1
Application
ANDA 203379
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of GLYBURIDE
- 1992GLYBURIDE (MICRONIZED)Brand (NDA)
NDA 020055 · SANOFI AVENTIS US
- 1992GLYNASEBrand (NDA)
NDA 020051 · PFIZER
- 1984DIABETABrand (NDA)
NDA 017532 · SANOFI AVENTIS US
- 1984MICRONASEBrand (NDA)
NDA 017498 · PFIZER
- 2019GLYBURIDEGeneric (ANDA)
ANDA 206483 · ORIENT PHARMA CO LTD
- 2016GLYBURIDEGeneric (ANDA)
ANDA 206749 · ZYDUS PHARMS
- 2016GLYBURIDEGeneric (ANDA)
ANDA 203581 · CHARTWELL RX
- 2015GLYBURIDEGeneric (ANDA)
ANDA 206079 · IMPAX LABS INC
- 2011GLYBURIDEGeneric (ANDA)
ANDA 090937 · HERITAGE
- 2007GLYBURIDEGeneric (ANDA)
ANDA 077537 · AUROBINDO PHARMA
- 2003GLYBURIDE (MICRONIZED)Generic (ANDA)
ANDA 075890 · HIKMA
- 2002GLYBURIDEGeneric (ANDA)
ANDA 075947 · ACTAVIS ELIZABETH
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.
