Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 012754
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TORECAN THIETHYLPERAZINE MALATE 5MG/ML INJECTABLE;INJECTION Discontinued None 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
07/18/1961 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
05/10/2001 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

08/06/1997 SUPPL-34 Labeling

Label is not available on this site.

12/17/1996 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

09/19/1995 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

07/08/1993 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

09/02/1993 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

08/06/1997 SUPPL-28 Labeling

Label is not available on this site.

09/14/1993 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

08/06/1997 SUPPL-25 Labeling

Label is not available on this site.

09/22/1989 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

08/08/1989 SUPPL-23 Labeling

Label is not available on this site.

02/28/1989 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

04/20/1988 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

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