Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076943
Company: HIKMA
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/01/2005 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/076943_ORIGINAL APPROVAL_PACKAGE.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/26/2012 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

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

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