Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 012753
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TORECAN THIETHYLPERAZINE MALEATE 10MG TABLET;ORAL 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 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
12/03/2001 SUPPL-68 Manufacturing (CMC)

Label is not available on this site.

07/19/2001 SUPPL-67 Manufacturing (CMC)

Label is not available on this site.

05/09/2001 SUPPL-66 Manufacturing (CMC)

Label is not available on this site.

05/15/2000 SUPPL-65 Manufacturing (CMC)

Label is not available on this site.

08/06/1997 SUPPL-64 Labeling

Label is not available on this site.

12/02/1996 SUPPL-63 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/1995 SUPPL-62 Manufacturing (CMC)

Label is not available on this site.

10/17/1995 SUPPL-61 Manufacturing (CMC)-Control

Label is not available on this site.

02/27/1995 SUPPL-60 Manufacturing (CMC)-Control

Label is not available on this site.

07/07/1993 SUPPL-59 Manufacturing (CMC)-Control

Label is not available on this site.

08/06/1997 SUPPL-57 Labeling

Label is not available on this site.

09/14/1993 SUPPL-56 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/30/1990 SUPPL-55 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/28/1994 SUPPL-54 Manufacturing (CMC)-Control

Label is not available on this site.

03/14/1990 SUPPL-52 Manufacturing (CMC)-Control

Label is not available on this site.

08/06/1997 SUPPL-51 Labeling

Label is not available on this site.

02/23/1990 SUPPL-50 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/08/1989 SUPPL-49 Labeling

Label is not available on this site.

08/08/1989 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.

02/23/1990 SUPPL-47 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/12/1988 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

09/26/1986 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

12/31/1985 SUPPL-42 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/17/1986 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

04/16/1984 SUPPL-40 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/06/1976 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English