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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091664
Company: LUPIN LTD

Products on ANDA 091664

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB3	No	No
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB3	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091664

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/19/2013	ORIG-1	Approval	Not Applicable		Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/091664Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/091664Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/05/2019	SUPPL-6	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
09/05/2019	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 091664

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/19/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/091664Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 091664

METFORMIN HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL; 500MG
TE Code = AB3

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GLUMETZA	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB3	021748	SANTARUS INC
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	203755	ACTAVIS LABS FL INC
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	213962	AJANTA PHARMA LTD
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	213356	APOTEX
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	212969	GLENMARK PHARMS LTD
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	213344	GRANULES
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	091664	LUPIN LTD
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	212448	MICRO LABS
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	212681	PRINSTON INC
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	215629	RK PHARMA
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	213334	SCIEGEN PHARMS INC
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	202917	SUN PHARM

TABLET, EXTENDED RELEASE;ORAL; 1GM
TE Code = AB3

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GLUMETZA	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB3	021748	SANTARUS INC
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	203755	ACTAVIS LABS FL INC
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	213962	AJANTA PHARMA LTD
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	213356	APOTEX
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	212969	GLENMARK PHARMS LTD
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	213344	GRANULES
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	091664	LUPIN LTD
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	211163	MACLEODS PHARMS LTD
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	212448	MICRO LABS
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	212681	PRINSTON INC
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	215629	RK PHARMA
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	213334	SCIEGEN PHARMS INC
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	202917	SUN PHARM

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