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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078728
Company: HERITAGE PHARMS

Products on ANDA 078728

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078728

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/23/2010	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
04/05/2017	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
04/04/2017	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078728

GLIPIZIDE AND METFORMIN HYDROCHLORIDE

TABLET;ORAL; 2.5MG;250MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GLIPIZIDE AND METFORMIN HYDROCHLORIDE	GLIPIZIDE; METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET;ORAL	Prescription	No	AB	077507	EPIC PHARMA LLC
GLIPIZIDE AND METFORMIN HYDROCHLORIDE	GLIPIZIDE; METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET;ORAL	Prescription	No	AB	078728	HERITAGE PHARMS
GLIPIZIDE AND METFORMIN HYDROCHLORIDE	GLIPIZIDE; METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET;ORAL	Prescription	No	AB	077270	TEVA PHARMS
GLIPIZIDE AND METFORMIN HYDROCHLORIDE	GLIPIZIDE; METFORMIN HYDROCHLORIDE	2.5MG;250MG	TABLET;ORAL	Prescription	No	AB	078905	ZYDUS PHARMS USA INC

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GLIPIZIDE AND METFORMIN HYDROCHLORIDE	GLIPIZIDE; METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET;ORAL	Prescription	No	AB	077507	EPIC PHARMA LLC
GLIPIZIDE AND METFORMIN HYDROCHLORIDE	GLIPIZIDE; METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET;ORAL	Prescription	No	AB	078728	HERITAGE PHARMS
GLIPIZIDE AND METFORMIN HYDROCHLORIDE	GLIPIZIDE; METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET;ORAL	Prescription	No	AB	077270	TEVA PHARMS
GLIPIZIDE AND METFORMIN HYDROCHLORIDE	GLIPIZIDE; METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET;ORAL	Prescription	No	AB	078905	ZYDUS PHARMS USA INC

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GLIPIZIDE AND METFORMIN HYDROCHLORIDE	GLIPIZIDE; METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET;ORAL	Prescription	No	AB	077507	EPIC PHARMA LLC
GLIPIZIDE AND METFORMIN HYDROCHLORIDE	GLIPIZIDE; METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET;ORAL	Prescription	No	AB	078728	HERITAGE PHARMS
GLIPIZIDE AND METFORMIN HYDROCHLORIDE	GLIPIZIDE; METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET;ORAL	Prescription	No	AB	077270	TEVA PHARMS
GLIPIZIDE AND METFORMIN HYDROCHLORIDE	GLIPIZIDE; METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET;ORAL	Prescription	No	AB	078905	ZYDUS PHARMS USA INC

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