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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076716
Company: ACTAVIS ELIZABETH

Products on ANDA 076716

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 076716

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/28/2005	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
03/04/2021	SUPPL-36	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
03/04/2021	SUPPL-32	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
03/04/2021	SUPPL-28	Labeling-Patient Package Insert		Label is not available on this site.
09/27/2011	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
08/11/2010	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
01/19/2010	SUPPL-15	Labeling		Label is not available on this site.
01/19/2010	SUPPL-14	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076716

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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