Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017247
Company: NOVARTIS

Products on NDA 017247

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SANOREX	MAZINDOL	1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
SANOREX	MAZINDOL	2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 017247

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/14/1973	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
09/17/2001	SUPPL-42	Manufacturing (CMC)		Label is not available on this site.
02/27/1996	SUPPL-41	Manufacturing (CMC)		Label is not available on this site.
10/17/1995	SUPPL-40	Manufacturing (CMC)-Control		Label is not available on this site.
09/19/1994	SUPPL-38	Manufacturing (CMC)-Control		Label is not available on this site.
03/13/1995	SUPPL-37	Manufacturing (CMC)-Control		Label is not available on this site.
11/27/1992	SUPPL-36	Labeling		Label is not available on this site.
08/02/1991	SUPPL-34	Manufacturing (CMC)-Control		Label is not available on this site.
03/29/1994	SUPPL-33	Manufacturing (CMC)-Control		Label is not available on this site.
03/14/1990	SUPPL-32	Manufacturing (CMC)-Control		Label is not available on this site.
09/14/1989	SUPPL-31	Manufacturing (CMC)		Label is not available on this site.
11/18/1986	SUPPL-29	Labeling		Label is not available on this site.
06/25/1981	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.
01/21/1981	SUPPL-26	Manufacturing (CMC)-Packaging		Label is not available on this site.
01/06/1982	SUPPL-25	Labeling		Label is not available on this site.
01/16/1979	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
03/23/1979	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
09/19/1979	SUPPL-21	Manufacturing (CMC)-Control		Label is not available on this site.
06/28/1977	SUPPL-20	Manufacturing (CMC)-Packaging		Label is not available on this site.
09/20/1976	SUPPL-19	Labeling		Label is not available on this site.
05/10/1976	SUPPL-18	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/31/1976	SUPPL-17	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/06/1975	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
11/15/1974	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
11/15/1974	SUPPL-11	Labeling		Label is not available on this site.
11/15/1974	SUPPL-10	Labeling		Label is not available on this site.