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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076345
Company: IMPAX LABS INC

Products on ANDA 076345

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GLYBURIDE AND METFORMIN HYDROCHLORIDE	GLYBURIDE; METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET;ORAL	Prescription	AB	No	No
GLYBURIDE AND METFORMIN HYDROCHLORIDE	GLYBURIDE; METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET;ORAL	Prescription	AB	No	No
GLYBURIDE AND METFORMIN HYDROCHLORIDE	GLYBURIDE; METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076345

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/18/2004	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76345ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/24/2021	SUPPL-36	Labeling-Package Insert		Label is not available on this site.
06/24/2021	SUPPL-34	Labeling-Package Insert		Label is not available on this site.
04/08/2015	SUPPL-32	Labeling-Package Insert		Label is not available on this site.
09/27/2011	SUPPL-30	Labeling-Package Insert		Label is not available on this site.
04/27/2010	SUPPL-29	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
02/04/2014	SUPPL-26	Labeling		Label is not available on this site.
03/16/2009	SUPPL-23	Labeling		Label is not available on this site.
12/05/2008	SUPPL-22	Labeling		Label is not available on this site.
04/08/2015	SUPPL-19	Labeling		Label is not available on this site.
07/27/2007	SUPPL-16	Labeling		Label is not available on this site.
11/21/2007	SUPPL-13	Labeling		Label is not available on this site.
03/02/2006	SUPPL-7	Labeling		Label is not available on this site.
07/26/2005	SUPPL-5	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076345

GLYBURIDE AND METFORMIN HYDROCHLORIDE

TABLET;ORAL; 1.25MG;250MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GLYBURIDE AND METFORMIN HYDROCHLORIDE	GLYBURIDE; METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET;ORAL	Prescription	No	AB	076716	ACTAVIS ELIZABETH
GLYBURIDE AND METFORMIN HYDROCHLORIDE	GLYBURIDE; METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET;ORAL	Prescription	No	AB	077870	AUROBINDO PHARMA
GLYBURIDE AND METFORMIN HYDROCHLORIDE	GLYBURIDE; METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET;ORAL	Prescription	No	AB	079009	HERITAGE PHARMS
GLYBURIDE AND METFORMIN HYDROCHLORIDE	GLYBURIDE; METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET;ORAL	Prescription	No	AB	076345	IMPAX LABS INC
GLYBURIDE AND METFORMIN HYDROCHLORIDE	GLYBURIDE; METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET;ORAL	Prescription	No	AB	206748	ZYDUS PHARMS

TABLET;ORAL; 2.5MG;500MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GLYBURIDE AND METFORMIN HYDROCHLORIDE	GLYBURIDE; METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET;ORAL	Prescription	No	AB	076716	ACTAVIS ELIZABETH
GLYBURIDE AND METFORMIN HYDROCHLORIDE	GLYBURIDE; METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET;ORAL	Prescription	No	AB	077870	AUROBINDO PHARMA
GLYBURIDE AND METFORMIN HYDROCHLORIDE	GLYBURIDE; METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET;ORAL	Prescription	No	AB	079009	HERITAGE PHARMS
GLYBURIDE AND METFORMIN HYDROCHLORIDE	GLYBURIDE; METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET;ORAL	Prescription	No	AB	076345	IMPAX LABS INC
GLYBURIDE AND METFORMIN HYDROCHLORIDE	GLYBURIDE; METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET;ORAL	Prescription	No	AB	206748	ZYDUS PHARMS

TABLET;ORAL; 5MG;500MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GLYBURIDE AND METFORMIN HYDROCHLORIDE	GLYBURIDE; METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET;ORAL	Prescription	No	AB	076716	ACTAVIS ELIZABETH
GLYBURIDE AND METFORMIN HYDROCHLORIDE	GLYBURIDE; METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET;ORAL	Prescription	No	AB	077870	AUROBINDO PHARMA
GLYBURIDE AND METFORMIN HYDROCHLORIDE	GLYBURIDE; METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET;ORAL	Prescription	No	AB	079009	HERITAGE PHARMS
GLYBURIDE AND METFORMIN HYDROCHLORIDE	GLYBURIDE; METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET;ORAL	Prescription	No	AB	076345	IMPAX LABS INC
GLYBURIDE AND METFORMIN HYDROCHLORIDE	GLYBURIDE; METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET;ORAL	Prescription	No	AB	206748	ZYDUS PHARMS

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