Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076894
Company: APOTEX INC
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
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

TORSEMIDE

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEMADEX TORSEMIDE 5MG TABLET;ORAL Prescription Yes AB 020136 MYLAN SPECIALITY LP
TORSEMIDE TORSEMIDE 5MG TABLET;ORAL Prescription No AB 076894 APOTEX INC
TORSEMIDE TORSEMIDE 5MG TABLET;ORAL Prescription No AB 078249 AUROBINDO PHARMA
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 076226 PAR PHARM
TORSEMIDE TORSEMIDE 5MG TABLET;ORAL Prescription No AB 076346 PLIVA PHARM IND
TORSEMIDE TORSEMIDE 5MG TABLET;ORAL Prescription No AB 076110 TEVA
TORSEMIDE TORSEMIDE 5MG TABLET;ORAL Prescription No AB 090613 VINTAGE PHARMS

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEMADEX TORSEMIDE 10MG TABLET;ORAL Prescription Yes AB 020136 MYLAN SPECIALITY LP
TORSEMIDE TORSEMIDE 10MG TABLET;ORAL Prescription No AB 076894 APOTEX INC
TORSEMIDE TORSEMIDE 10MG TABLET;ORAL Prescription No AB 078249 AUROBINDO PHARMA
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 076226 PAR PHARM
TORSEMIDE TORSEMIDE 10MG TABLET;ORAL Prescription No AB 076346 PLIVA PHARM IND
TORSEMIDE TORSEMIDE 10MG TABLET;ORAL Prescription No AB 076110 TEVA
TORSEMIDE TORSEMIDE 10MG TABLET;ORAL Prescription No AB 090613 VINTAGE PHARMS

TABLET;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEMADEX TORSEMIDE 20MG TABLET;ORAL Prescription Yes AB 020136 MYLAN SPECIALITY LP
TORSEMIDE TORSEMIDE 20MG TABLET;ORAL Prescription No AB 076894 APOTEX INC
TORSEMIDE TORSEMIDE 20MG TABLET;ORAL Prescription No AB 078249 AUROBINDO PHARMA
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 076226 PAR PHARM
TORSEMIDE TORSEMIDE 20MG TABLET;ORAL Prescription No AB 076346 PLIVA PHARM IND
TORSEMIDE TORSEMIDE 20MG TABLET;ORAL Prescription No AB 076110 TEVA
TORSEMIDE TORSEMIDE 20MG TABLET;ORAL Prescription No AB 090613 VINTAGE PHARMS

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEMADEX TORSEMIDE 100MG TABLET;ORAL Prescription Yes AB 020136 MYLAN SPECIALITY LP
TORSEMIDE TORSEMIDE 100MG TABLET;ORAL Prescription No AB 076894 APOTEX INC
TORSEMIDE TORSEMIDE 100MG TABLET;ORAL Prescription No AB 078249 AUROBINDO PHARMA
TORSEMIDE TORSEMIDE 100MG TABLET;ORAL Prescription No AB 079234 HETERO LABS LTD III
TORSEMIDE TORSEMIDE 100MG TABLET;ORAL Prescription No AB 076226 PAR PHARM
TORSEMIDE TORSEMIDE 100MG TABLET;ORAL Prescription No AB 076346 PLIVA PHARM IND
TORSEMIDE TORSEMIDE 100MG TABLET;ORAL Prescription No AB 076110 TEVA
TORSEMIDE TORSEMIDE 100MG TABLET;ORAL Prescription No AB 090613 VINTAGE PHARMS

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