Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020137
Company: ROCHE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEMADEX TORSEMIDE 20MG/2ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
DEMADEX TORSEMIDE 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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 3 - New Dosage Form 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
04/20/1998 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

01/07/1998 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

02/13/1998 SUPPL-9 Efficacy-New Dosing Regimen

Label is not available on this site.

09/09/1997 SUPPL-8 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
06/17/1996 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

11/01/1995 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

10/24/1995 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

11/15/1995 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) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18735slr044and20137slr002LTR.pdf
09/05/1995 SUPPL-1 Labeling

Label is not available on this site.

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