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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076257
Company: EPIC PHARMA LLC

Products on ANDA 076257

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076257

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/27/2002	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
04/13/2015	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
04/13/2015	SUPPL-10	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
09/30/2010	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
06/23/2010	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
08/19/2010	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
09/18/2009	SUPPL-4	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076257

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	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
GLYBURIDE	GLYBURIDE	1.25MG	TABLET;ORAL	Prescription	No	AB1	206483	ORIENT PHARMA CO LTD
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	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
GLYBURIDE	GLYBURIDE	2.5MG	TABLET;ORAL	Prescription	No	AB1	206483	ORIENT PHARMA CO LTD
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	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
GLYBURIDE	GLYBURIDE	5MG	TABLET;ORAL	Prescription	No	AB1	206483	ORIENT PHARMA CO LTD
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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