Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012753
Company: NOVARTIS

Products on NDA 012753

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TORECAN	THIETHYLPERAZINE MALEATE	10MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 012753

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.