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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077064
Company: ZYDUS PHARMS USA

Products on ANDA 077064

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET;ORAL	Prescription	AB	No	No
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET;ORAL	Prescription	AB	No	No
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077064

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/18/2005	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
04/13/2015	SUPPL-26	Labeling-Package Insert		Label is not available on this site.
12/28/2009	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
05/19/2011	SUPPL-15	Labeling		Label is not available on this site.
08/11/2009	SUPPL-12	Labeling		Label is not available on this site.
01/28/2008	SUPPL-9	Labeling		Label is not available on this site.
04/12/2010	SUPPL-8	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 077064

METFORMIN HYDROCHLORIDE

TABLET;ORAL; 500MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET;ORAL	Prescription	No	AB	091184	ALKEM
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET;ORAL	Prescription	No	AB	077095	AUROBINDO
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET;ORAL	Prescription	No	AB	075972	CHARTWELL
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET;ORAL	Prescription	No	AB	205096	CSPC OUYI
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET;ORAL	Prescription	No	AB	077787	DR REDDYS LABS INC
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET;ORAL	Prescription	No	AB	075965	EPIC PHARMA LLC
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET;ORAL	Prescription	No	AB	090564	GRANULES INDIA
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET;ORAL	Prescription	No	AB	213320	HARMAN FINOCHEM
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET;ORAL	Prescription	No	AB	209882	LAURUS
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET;ORAL	Prescription	No	AB	090888	MARKSANS PHARMA
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET;ORAL	Prescription	No	AB	075973	MYLAN
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET;ORAL	Prescription	No	AB	203769	SCIEGEN PHARMS
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET;ORAL	Prescription	No	AB	076033	SENORES PHARMS
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET;ORAL	Prescription	No	AB	203686	ZYDUS HLTHCARE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET;ORAL	Prescription	No	AB	077064	ZYDUS PHARMS USA

TABLET;ORAL; 850MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET;ORAL	Prescription	No	AB	091184	ALKEM
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET;ORAL	Prescription	No	AB	077095	AUROBINDO
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET;ORAL	Prescription	No	AB	075972	CHARTWELL
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET;ORAL	Prescription	No	AB	205096	CSPC OUYI
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET;ORAL	Prescription	No	AB	077787	DR REDDYS LABS INC
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET;ORAL	Prescription	No	AB	075965	EPIC PHARMA LLC
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET;ORAL	Prescription	No	AB	090564	GRANULES INDIA
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET;ORAL	Prescription	No	AB	213320	HARMAN FINOCHEM
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET;ORAL	Prescription	No	AB	209882	LAURUS
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET;ORAL	Prescription	No	AB	090888	MARKSANS PHARMA
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET;ORAL	Prescription	No	AB	075973	MYLAN
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET;ORAL	Prescription	No	AB	203769	SCIEGEN PHARMS
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET;ORAL	Prescription	No	AB	076033	SENORES PHARMS
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET;ORAL	Prescription	No	AB	203686	ZYDUS HLTHCARE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET;ORAL	Prescription	No	AB	077064	ZYDUS PHARMS USA

TABLET;ORAL; 1GM
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET;ORAL	Prescription	No	AB	091184	ALKEM
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET;ORAL	Prescription	No	AB	077095	AUROBINDO
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET;ORAL	Prescription	No	AB	075972	CHARTWELL
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET;ORAL	Prescription	No	AB	205096	CSPC OUYI
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET;ORAL	Prescription	No	AB	077787	DR REDDYS LABS INC
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET;ORAL	Prescription	No	AB	075965	EPIC PHARMA LLC
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET;ORAL	Prescription	No	AB	090564	GRANULES INDIA
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET;ORAL	Prescription	No	AB	213320	HARMAN FINOCHEM
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET;ORAL	Prescription	No	AB	209882	LAURUS
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET;ORAL	Prescription	No	AB	090888	MARKSANS PHARMA
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET;ORAL	Prescription	No	AB	075973	MYLAN
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET;ORAL	Prescription	No	AB	203769	SCIEGEN PHARMS
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET;ORAL	Prescription	No	AB	076033	SENORES PHARMS
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET;ORAL	Prescription	No	AB	203686	ZYDUS HLTHCARE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET;ORAL	Prescription	No	AB	077064	ZYDUS PHARMS USA

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