Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 013247
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TORECAN THIETHYLPERAZINE MALEATE 10MG SUPPOSITORY;RECTAL 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
04/11/1963 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
07/07/1993 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

03/05/1990 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

09/12/1988 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

09/26/1986 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

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