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FDA Orange Book · active-ingredient family

Glyburide

Glyburide is approved as 4 brand and 15 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:GLYNASE · NDA 020051

4

Brand (NDA)

15

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
GLYNASERLD×4PFIZERNDA 020051—Mar 04, 1992
DIABETARLD×3SANOFI AVENTIS USNDA 017532AB2May 01, 1984
MICRONASERLD×3PFIZERNDA 017498—May 01, 1984
GLYBURIDE (MICRONIZED)×3SANOFI AVENTIS USNDA 020055—Apr 17, 1992

Generic (ANDA) products (15)

ProductApplicantApplicationTEApproved
GLYBURIDE×3ORIENT PHARMA CO LTDANDA 206483AB1Feb 22, 2019
GLYBURIDE×3CADILA PHARMS LTDANDA 203379AB1Jan 04, 2019
GLYBURIDE×3ZYDUS PHARMSANDA 206749AB1May 10, 2016
GLYBURIDE×3CHARTWELL RXANDA 203581—Apr 14, 2016
GLYBURIDE×3IMPAX LABS INCANDA 206079AB2Sep 30, 2015
GLYBURIDE×3HERITAGEANDA 090937AB1Feb 28, 2011
GLYBURIDE×3AUROBINDO PHARMAANDA 077537—Oct 18, 2007
GLYBURIDE (MICRONIZED)×3HIKMAANDA 075890—Jul 31, 2003
GLYBURIDE×3ACTAVIS ELIZABETHANDA 075947—Nov 14, 2002
GLYBURIDE×3EPIC PHARMA LLCANDA 076257AB1Jun 27, 2002
GLYBURIDE (MICRONIZED)×4TEVAANDA 074686—Apr 20, 1999
GLYBURIDE (MICRONIZED)×3NATCO PHARMAANDA 074792—Jun 26, 1998
GLYBURIDE (MICRONIZED)×2CHARTWELL RXANDA 075174—Jun 22, 1998
GLYBURIDE (MICRONIZED)×4STRIDES PHARMA INTLANDA 074591—Dec 22, 1997
GLYBURIDE×3TEVAANDA 074388AB1Aug 29, 1995

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.

Glyburide — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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