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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077492
Company: OHM LABS INC

Products on ANDA 077492

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 077492

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/26/2014	ORIG-1	Approval			Label (PDF) Letter (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/077492Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077492Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/077492Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/20/2019	SUPPL-12	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
08/20/2019	SUPPL-11	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
08/20/2019	SUPPL-6	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
12/17/2015	SUPPL-3	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
12/17/2015	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 077492

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/26/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/077492Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 077492

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 INC
VALSARTAN	VALSARTAN	40MG	TABLET;ORAL	Prescription	No	AB	205347	SQUARE PHARMS

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 INC
VALSARTAN	VALSARTAN	80MG	TABLET;ORAL	Prescription	No	AB	205347	SQUARE PHARMS

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 INC
VALSARTAN	VALSARTAN	160MG	TABLET;ORAL	Prescription	No	AB	205347	SQUARE PHARMS

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 INC
VALSARTAN	VALSARTAN	320MG	TABLET;ORAL	Prescription	No	AB	205347	SQUARE PHARMS

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