Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074388
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GLYBURIDE GLYBURIDE 1.25MG TABLET;ORAL Prescription AB1 No No
GLYBURIDE GLYBURIDE 2.5MG TABLET;ORAL Prescription AB1 No No
GLYBURIDE GLYBURIDE 5MG TABLET;ORAL Prescription AB1 No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/29/1995 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/03/2015 SUPPL-46 Labeling-Package Insert

Label is not available on this site.

01/16/2015 SUPPL-43 Labeling-Package Insert

Label is not available on this site.

01/23/2014 SUPPL-41 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

09/23/2010 SUPPL-37 Labeling-Package Insert

Label is not available on this site.

06/23/2010 SUPPL-36 Labeling-Package Insert

Label is not available on this site.

12/11/2014 SUPPL-35 Labeling-Container/Carton Labels

Label is not available on this site.

05/01/2009 SUPPL-32 Labeling

Label is not available on this site.

09/11/2012 SUPPL-31 Labeling

Label is not available on this site.

01/23/2014 SUPPL-30 Labeling

Label is not available on this site.

01/15/2009 SUPPL-29 Labeling

Label is not available on this site.

02/26/2002 SUPPL-17 Manufacturing (CMC)-Facility

Label is not available on this site.

07/18/2001 SUPPL-16 Manufacturing (CMC)-Facility

Label is not available on this site.

01/20/2000 SUPPL-15 Labeling

Label is not available on this site.

06/26/2000 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

06/26/2000 SUPPL-13 Manufacturing (CMC)-Facility

Label is not available on this site.

03/23/1999 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/04/1999 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/02/1998 SUPPL-7 Labeling

Label is not available on this site.

06/08/1998 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/02/1998 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/15/1997 SUPPL-4 Labeling

Label is not available on this site.

02/02/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/27/1998 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/27/1998 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

GLYBURIDE

TABLET;ORAL; 1.25MG
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GLYBURIDE GLYBURIDE 1.25MG TABLET;ORAL Prescription No AB1 077537 AUROBINDO PHARMA
GLYBURIDE GLYBURIDE 1.25MG TABLET;ORAL Prescription No AB1 203379 CADILA PHARMS LTD
GLYBURIDE GLYBURIDE 1.25MG TABLET;ORAL Prescription No AB1 076257 EPIC PHARMA LLC
GLYBURIDE GLYBURIDE 1.25MG TABLET;ORAL Prescription No AB1 090937 HERITAGE PHARMS INC
GLYBURIDE GLYBURIDE 1.25MG TABLET;ORAL Prescription No AB1 206483 ORIENT PHARMA CO LTD
GLYBURIDE GLYBURIDE 1.25MG TABLET;ORAL Prescription No AB1 203581 PHARMADAX INC
GLYBURIDE GLYBURIDE 1.25MG TABLET;ORAL Prescription No AB1 074388 TEVA
GLYBURIDE GLYBURIDE 1.25mg TABLET;ORAL Prescription No AB1 206749 ZYDUS PHARMS

TABLET;ORAL; 2.5MG
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GLYBURIDE GLYBURIDE 2.5MG TABLET;ORAL Prescription No AB1 077537 AUROBINDO PHARMA
GLYBURIDE GLYBURIDE 2.5MG TABLET;ORAL Prescription No AB1 203379 CADILA PHARMS LTD
GLYBURIDE GLYBURIDE 2.5MG TABLET;ORAL Prescription No AB1 076257 EPIC PHARMA LLC
GLYBURIDE GLYBURIDE 2.5MG TABLET;ORAL Prescription No AB1 090937 HERITAGE PHARMS INC
GLYBURIDE GLYBURIDE 2.5MG TABLET;ORAL Prescription No AB1 206483 ORIENT PHARMA CO LTD
GLYBURIDE GLYBURIDE 2.5MG TABLET;ORAL Prescription No AB1 203581 PHARMADAX INC
GLYBURIDE GLYBURIDE 2.5MG TABLET;ORAL Prescription No AB1 074388 TEVA
GLYBURIDE GLYBURIDE 2.5mg TABLET;ORAL Prescription No AB1 206749 ZYDUS PHARMS

TABLET;ORAL; 5MG
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GLYBURIDE GLYBURIDE 5MG TABLET;ORAL Prescription No AB1 077537 AUROBINDO PHARMA
GLYBURIDE GLYBURIDE 5MG TABLET;ORAL Prescription No AB1 203379 CADILA PHARMS LTD
GLYBURIDE GLYBURIDE 5MG TABLET;ORAL Prescription No AB1 076257 EPIC PHARMA LLC
GLYBURIDE GLYBURIDE 5MG TABLET;ORAL Prescription No AB1 090937 HERITAGE PHARMS INC
GLYBURIDE GLYBURIDE 5MG TABLET;ORAL Prescription No AB1 206483 ORIENT PHARMA CO LTD
GLYBURIDE GLYBURIDE 5MG TABLET;ORAL Prescription No AB1 203581 PHARMADAX INC
GLYBURIDE GLYBURIDE 5MG TABLET;ORAL Prescription No AB1 074388 TEVA
GLYBURIDE GLYBURIDE 5MG TABLET;ORAL Prescription No AB1 206749 ZYDUS PHARMS

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