Orange Book product · Brand (NDA)
MICRONASE
GLYBURIDE
At a glance
May 01, 1984
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 01, 1984
42 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
GLYBURIDE
Strength
1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 017498
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.
- 1992GLYBURIDE (MICRONIZED)Brand (NDA)
NDA 020055 · SANOFI AVENTIS US
- 1992GLYNASEBrand (NDA)
NDA 020051 · PFIZER
- 1984DIABETABrand (NDA)
NDA 017532 · SANOFI AVENTIS US
- 2019GLYBURIDEGeneric (ANDA)
ANDA 206483 · ORIENT PHARMA CO LTD
- 2019GLYBURIDEGeneric (ANDA)
ANDA 203379 · CADILA PHARMS 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.
