Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076864
Company: TEVA

Products on ANDA 076864

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076864

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/12/2005	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
03/01/2019	SUPPL-16	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
03/01/2019	SUPPL-15	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
10/22/2010	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
04/27/2010	SUPPL-9	Labeling		Label is not available on this site.
12/13/2011	SUPPL-6	Labeling		Label is not available on this site.
04/18/2007	SUPPL-4	Labeling		Label is not available on this site.
01/03/2007	SUPPL-3	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076864

METFORMIN HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL; 750MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	076869	ACTAVIS LABS FL INC
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	206145	ALKEM LABS LTD
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	078596	AMNEAL PHARMS NY
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	079118	AUROBINDO PHARMA LTD
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	207427	BEXIMCO PHARMS USA
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	078321	CSPC OUYI
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	209313	GRANULES
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	202306	INTELLIPHARMACEUTICS
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	217631	LAURUS
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	206955	MACLEODS PHARMS LTD
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	090295	MARKSANS PHARMA
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	076756	NOSTRUM PHARMS LLC
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	208880	PRINSTON INC
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	077336	SUN PHARM INDS (IN)
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	076864	TEVA
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	213359	UNICHEM
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	211052	YICHANG HUMANWELL
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	077078	ZYDUS LIFESCIENCES