Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077537
Company: AUROBINDO PHARMA

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 No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/18/2007 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
10/06/2015 SUPPL-11 Labeling-Package Insert

Label is not available on this site.
02/25/2015 SUPPL-10 Labeling-Package Insert

Label is not available on this site.
09/28/2012 SUPPL-7 Labeling-Package Insert

Label is not available on this site.
03/20/2009 SUPPL-4 Labeling

Label is not available on this site.
12/31/2008 SUPPL-3 Labeling

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 USA INC

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 USA INC

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 USA INC

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