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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 079234
Company: HETERO LABS LTD III

Products on ANDA 079234

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TORSEMIDE	TORSEMIDE	5MG	TABLET;ORAL	Prescription	AB	No	No
TORSEMIDE	TORSEMIDE	10MG	TABLET;ORAL	Prescription	AB	No	No
TORSEMIDE	TORSEMIDE	20MG	TABLET;ORAL	Prescription	AB	No	No
TORSEMIDE	TORSEMIDE	100MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 079234

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/27/2009	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
01/07/2013	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
09/26/2012	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 079234

TORSEMIDE

TABLET;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TORSEMIDE	TORSEMIDE	5MG	TABLET;ORAL	Prescription	No	AB	078249	AUROBINDO PHARMA
TORSEMIDE	TORSEMIDE	5MG	TABLET;ORAL	Prescription	No	AB	076894	HERITAGE
TORSEMIDE	TORSEMIDE	5MG	TABLET;ORAL	Prescription	No	AB	079234	HETERO LABS LTD III
TORSEMIDE	TORSEMIDE	5MG	TABLET;ORAL	Prescription	No	AB	076943	HIKMA
TORSEMIDE	TORSEMIDE	5MG	TABLET;ORAL	Prescription	No	AB	076346	PLIVA PHARM IND
TORSEMIDE	TORSEMIDE	5MG	TABLET;ORAL	Prescription	No	AB	076226	STRIDES PHARMA
TORSEMIDE	TORSEMIDE	5MG	TABLET;ORAL	Prescription	No	AB	090613	STRIDES PHARMA

TABLET;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TORSEMIDE	TORSEMIDE	10MG	TABLET;ORAL	Prescription	No	AB	078249	AUROBINDO PHARMA
TORSEMIDE	TORSEMIDE	10MG	TABLET;ORAL	Prescription	No	AB	076894	HERITAGE
TORSEMIDE	TORSEMIDE	10MG	TABLET;ORAL	Prescription	No	AB	079234	HETERO LABS LTD III
TORSEMIDE	TORSEMIDE	10MG	TABLET;ORAL	Prescription	No	AB	076943	HIKMA
TORSEMIDE	TORSEMIDE	10MG	TABLET;ORAL	Prescription	No	AB	076346	PLIVA PHARM IND
TORSEMIDE	TORSEMIDE	10MG	TABLET;ORAL	Prescription	No	AB	076226	STRIDES PHARMA
TORSEMIDE	TORSEMIDE	10MG	TABLET;ORAL	Prescription	No	AB	090613	STRIDES PHARMA

TABLET;ORAL; 20MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TORSEMIDE	TORSEMIDE	20MG	TABLET;ORAL	Prescription	No	AB	078249	AUROBINDO PHARMA
TORSEMIDE	TORSEMIDE	20MG	TABLET;ORAL	Prescription	No	AB	076894	HERITAGE
TORSEMIDE	TORSEMIDE	20MG	TABLET;ORAL	Prescription	No	AB	079234	HETERO LABS LTD III
TORSEMIDE	TORSEMIDE	20MG	TABLET;ORAL	Prescription	No	AB	076943	HIKMA
TORSEMIDE	TORSEMIDE	20MG	TABLET;ORAL	Prescription	No	AB	076346	PLIVA PHARM IND
TORSEMIDE	TORSEMIDE	20MG	TABLET;ORAL	Prescription	No	AB	076226	STRIDES PHARMA
TORSEMIDE	TORSEMIDE	20MG	TABLET;ORAL	Prescription	No	AB	090613	STRIDES PHARMA

TABLET;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TORSEMIDE	TORSEMIDE	100MG	TABLET;ORAL	Prescription	No	AB	078249	AUROBINDO PHARMA
TORSEMIDE	TORSEMIDE	100MG	TABLET;ORAL	Prescription	No	AB	076894	HERITAGE
TORSEMIDE	TORSEMIDE	100MG	TABLET;ORAL	Prescription	No	AB	079234	HETERO LABS LTD III
TORSEMIDE	TORSEMIDE	100MG	TABLET;ORAL	Prescription	No	AB	076346	PLIVA PHARM IND
TORSEMIDE	TORSEMIDE	100MG	TABLET;ORAL	Prescription	No	AB	076226	STRIDES PHARMA
TORSEMIDE	TORSEMIDE	100MG	TABLET;ORAL	Prescription	No	AB	090613	STRIDES PHARMA

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