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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077078
Company: CADILA

Products on ANDA 077078

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 077078

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/21/2005	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
10/31/2008	SUPPL-3	Labeling		Label is not available on this site.
01/28/2008	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 077078

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	077078	CADILA
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	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

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