Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020136
Company: MYLAN SPECIALITY LP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEMADEX TORSEMIDE 5MG TABLET;ORAL Prescription AB Yes No
DEMADEX TORSEMIDE 10MG TABLET;ORAL Prescription AB Yes No
DEMADEX TORSEMIDE 20MG TABLET;ORAL Prescription AB Yes Yes
DEMADEX TORSEMIDE 100MG TABLET;ORAL Prescription AB Yes 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
08/23/1993 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/03/2017 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020136s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020136Orig1s027ltr.pdf
11/22/2013 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

11/16/2012 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

08/14/2012 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020136s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020136Orig1s024ltr.pdf
01/27/2010 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020136s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020136s023ltr.pdf
09/17/2002 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/20/1998 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

03/16/1998 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

01/07/1998 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

11/26/1997 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

10/01/1997 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

05/30/1997 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

02/13/1998 SUPPL-11 Labeling

Label is not available on this site.

10/30/1996 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

09/09/1997 SUPPL-9 Efficacy-New Indication Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020136ap_s08_s09.pdf
11/30/1995 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

11/01/1995 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

10/24/1995 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

11/15/1995 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/14/1996 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/12/1995 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

08/09/1995 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

09/05/1995 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/03/2017 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020136s027lbl.pdf
08/14/2012 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020136s014lbl.pdf
01/27/2010 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020136s023lbl.pdf

DEMADEX

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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