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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201677
Company: LUPIN LTD

Products on ANDA 201677

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VALSARTAN	VALSARTAN	40MG	TABLET;ORAL	Prescription	AB	No	No
VALSARTAN	VALSARTAN	80MG	TABLET;ORAL	Prescription	AB	No	No
VALSARTAN	VALSARTAN	160MG	TABLET;ORAL	Prescription	AB	No	No
VALSARTAN	VALSARTAN	320MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 201677

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/05/2015	ORIG-1	Approval	Not Applicable			Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/03/2019	SUPPL-4	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
09/03/2019	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
11/20/2015	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 201677

VALSARTAN

TABLET;ORAL; 40MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIOVAN	VALSARTAN	40MG	TABLET;ORAL	Prescription	Yes	AB	021283	NOVARTIS
VALSARTAN	VALSARTAN	40MG	TABLET;ORAL	Prescription	No	AB	091367	ALEMBIC
VALSARTAN	VALSARTAN	40MG	TABLET;ORAL	Prescription	No	AB	205536	ALKEM LABS LTD
VALSARTAN	VALSARTAN	40MG	TABLET;ORAL	Prescription	No	AB	204011	AMNEAL PHARMS
VALSARTAN	VALSARTAN	40MG	TABLET;ORAL	Prescription	No	AB	202223	AUROBINDO PHARMA LTD
VALSARTAN	VALSARTAN	40MG	TABLET;ORAL	Prescription	No	AB	201618	DR REDDYS
VALSARTAN	VALSARTAN	40MG	TABLET;ORAL	Prescription	No	AB	203311	HETERO LABS LTD V
VALSARTAN	VALSARTAN	40MG	TABLET;ORAL	Prescription	No	AB	203536	JUBILANT GENERICS
VALSARTAN	VALSARTAN	40MG	TABLET;ORAL	Prescription	No	AB	201677	LUPIN LTD
VALSARTAN	VALSARTAN	40MG	TABLET;ORAL	Prescription	No	AB	202696	MACLEODS PHARMS LTD
VALSARTAN	VALSARTAN	40MG	TABLET;ORAL	Prescription	No	AB	090866	MYLAN
VALSARTAN	VALSARTAN	40MG	TABLET;ORAL	Prescription	No	AB	077492	OHM LABS INC
VALSARTAN	VALSARTAN	40MG	TABLET;ORAL	Prescription	No	AB	204821	PRINSTON INC
VALSARTAN	VALSARTAN	40MG	TABLET;ORAL	Prescription	No	AB	204038	SCIEGEN PHARMS
VALSARTAN	VALSARTAN	40MG	TABLET;ORAL	Prescription	No	AB	205347	SQUARE PHARMS PLC
VALSARTAN	VALSARTAN	40MG	TABLET;ORAL	Prescription	No	AB	218991	ZYDUS LIFESCIENCES

TABLET;ORAL; 80MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIOVAN	VALSARTAN	80MG	TABLET;ORAL	Prescription	Yes	AB	021283	NOVARTIS
VALSARTAN	VALSARTAN	80MG	TABLET;ORAL	Prescription	No	AB	091367	ALEMBIC
VALSARTAN	VALSARTAN	80MG	TABLET;ORAL	Prescription	No	AB	205536	ALKEM LABS LTD
VALSARTAN	VALSARTAN	80MG	TABLET;ORAL	Prescription	No	AB	204011	AMNEAL PHARMS
VALSARTAN	VALSARTAN	80MG	TABLET;ORAL	Prescription	No	AB	202223	AUROBINDO PHARMA LTD
VALSARTAN	VALSARTAN	80MG	TABLET;ORAL	Prescription	No	AB	201618	DR REDDYS
VALSARTAN	VALSARTAN	80MG	TABLET;ORAL	Prescription	No	AB	203311	HETERO LABS LTD V
VALSARTAN	VALSARTAN	80MG	TABLET;ORAL	Prescription	No	AB	203536	JUBILANT GENERICS
VALSARTAN	VALSARTAN	80MG	TABLET;ORAL	Prescription	No	AB	201677	LUPIN LTD
VALSARTAN	VALSARTAN	80MG	TABLET;ORAL	Prescription	No	AB	202696	MACLEODS PHARMS LTD
VALSARTAN	VALSARTAN	80MG	TABLET;ORAL	Prescription	No	AB	090866	MYLAN
VALSARTAN	VALSARTAN	80MG	TABLET;ORAL	Prescription	No	AB	077492	OHM LABS INC
VALSARTAN	VALSARTAN	80MG	TABLET;ORAL	Prescription	No	AB	204821	PRINSTON INC
VALSARTAN	VALSARTAN	80MG	TABLET;ORAL	Prescription	No	AB	204038	SCIEGEN PHARMS
VALSARTAN	VALSARTAN	80MG	TABLET;ORAL	Prescription	No	AB	205347	SQUARE PHARMS PLC
VALSARTAN	VALSARTAN	80MG	TABLET;ORAL	Prescription	No	AB	218991	ZYDUS LIFESCIENCES

TABLET;ORAL; 160MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIOVAN	VALSARTAN	160MG	TABLET;ORAL	Prescription	Yes	AB	021283	NOVARTIS
VALSARTAN	VALSARTAN	160MG	TABLET;ORAL	Prescription	No	AB	091367	ALEMBIC
VALSARTAN	VALSARTAN	160MG	TABLET;ORAL	Prescription	No	AB	205536	ALKEM LABS LTD
VALSARTAN	VALSARTAN	160MG	TABLET;ORAL	Prescription	No	AB	204011	AMNEAL PHARMS
VALSARTAN	VALSARTAN	160MG	TABLET;ORAL	Prescription	No	AB	202223	AUROBINDO PHARMA LTD
VALSARTAN	VALSARTAN	160MG	TABLET;ORAL	Prescription	No	AB	201618	DR REDDYS
VALSARTAN	VALSARTAN	160MG	TABLET;ORAL	Prescription	No	AB	203311	HETERO LABS LTD V
VALSARTAN	VALSARTAN	160MG	TABLET;ORAL	Prescription	No	AB	203536	JUBILANT GENERICS
VALSARTAN	VALSARTAN	160MG	TABLET;ORAL	Prescription	No	AB	201677	LUPIN LTD
VALSARTAN	VALSARTAN	160MG	TABLET;ORAL	Prescription	No	AB	202696	MACLEODS PHARMS LTD
VALSARTAN	VALSARTAN	160MG	TABLET;ORAL	Prescription	No	AB	090866	MYLAN
VALSARTAN	VALSARTAN	160MG	TABLET;ORAL	Prescription	No	AB	077492	OHM LABS INC
VALSARTAN	VALSARTAN	160MG	TABLET;ORAL	Prescription	No	AB	204821	PRINSTON INC
VALSARTAN	VALSARTAN	160MG	TABLET;ORAL	Prescription	No	AB	204038	SCIEGEN PHARMS
VALSARTAN	VALSARTAN	160MG	TABLET;ORAL	Prescription	No	AB	205347	SQUARE PHARMS PLC
VALSARTAN	VALSARTAN	160MG	TABLET;ORAL	Prescription	No	AB	218991	ZYDUS LIFESCIENCES

TABLET;ORAL; 320MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIOVAN	VALSARTAN	320MG	TABLET;ORAL	Prescription	Yes	AB	021283	NOVARTIS
VALSARTAN	VALSARTAN	320MG	TABLET;ORAL	Prescription	No	AB	091367	ALEMBIC
VALSARTAN	VALSARTAN	320MG	TABLET;ORAL	Prescription	No	AB	205536	ALKEM LABS LTD
VALSARTAN	VALSARTAN	320MG	TABLET;ORAL	Prescription	No	AB	204011	AMNEAL PHARMS
VALSARTAN	VALSARTAN	320MG	TABLET;ORAL	Prescription	No	AB	202223	AUROBINDO PHARMA LTD
VALSARTAN	VALSARTAN	320MG	TABLET;ORAL	Prescription	No	AB	201618	DR REDDYS
VALSARTAN	VALSARTAN	320MG	TABLET;ORAL	Prescription	No	AB	203311	HETERO LABS LTD V
VALSARTAN	VALSARTAN	320MG	TABLET;ORAL	Prescription	No	AB	203536	JUBILANT GENERICS
VALSARTAN	VALSARTAN	320MG	TABLET;ORAL	Prescription	No	AB	201677	LUPIN LTD
VALSARTAN	VALSARTAN	320MG	TABLET;ORAL	Prescription	No	AB	202696	MACLEODS PHARMS LTD
VALSARTAN	VALSARTAN	320MG	TABLET;ORAL	Prescription	No	AB	090866	MYLAN
VALSARTAN	VALSARTAN	320MG	TABLET;ORAL	Prescription	No	AB	077492	OHM LABS INC
VALSARTAN	VALSARTAN	320MG	TABLET;ORAL	Prescription	No	AB	204821	PRINSTON INC
VALSARTAN	VALSARTAN	320MG	TABLET;ORAL	Prescription	No	AB	204038	SCIEGEN PHARMS
VALSARTAN	VALSARTAN	320MG	TABLET;ORAL	Prescription	No	AB	205347	SQUARE PHARMS PLC
VALSARTAN	VALSARTAN	320MG	TABLET;ORAL	Prescription	No	AB	218991	ZYDUS LIFESCIENCES

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