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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076894
Company: COREPHARMA

Products on ANDA 076894

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 076894

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/31/2005	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/076894_ORIGINAL APPROVAL_PACKAGE.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/06/2013	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
09/28/2010	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
04/10/2008	SUPPL-4		Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/076894_S004_TORSEMIDE TABS.pdf
05/09/2008	SUPPL-3		Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/076894_S003_TORSEMIDE TABS.pdf
11/07/2007	SUPPL-2		Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/076894_S002_TORSEMIDE TABS.pdf
10/03/2007	SUPPL-1	Manufacturing (CMC)	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/076894_S001_TORSEMIDE TABS.pdf

Therapeutic Equivalents for ANDA 076894

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	COREPHARMA
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	COREPHARMA
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	COREPHARMA
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	COREPHARMA
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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