Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012516
Company: NOVARTIS

Products on NDA 012516

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SANSERT	METHYSERGIDE MALEATE	2MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 012516

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/12/1962	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY		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-50	Manufacturing (CMC)		Label is not available on this site.
05/10/2001	SUPPL-49	Manufacturing (CMC)		Label is not available on this site.
03/16/2000	SUPPL-48	Manufacturing (CMC)		Label is not available on this site.
04/21/1999	SUPPL-47	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/15/1999	SUPPL-46	Labeling		Label is not available on this site.
12/11/2000	SUPPL-45	Labeling		Label is not available on this site.
03/20/1996	SUPPL-44	Manufacturing (CMC)-Control		Label is not available on this site.
11/22/1995	SUPPL-43	Manufacturing (CMC)		Label is not available on this site.
10/17/1995	SUPPL-42	Manufacturing (CMC)-Control		Label is not available on this site.
12/11/2000	SUPPL-41	Labeling		Label is not available on this site.
10/15/1999	SUPPL-40	Labeling		Label is not available on this site.
12/11/2000	SUPPL-38	Labeling		Label is not available on this site.
08/10/1981	SUPPL-26	Manufacturing (CMC)		Label is not available on this site.
08/10/1981	SUPPL-25	Manufacturing (CMC)-Formulation		Label is not available on this site.
10/11/1978	SUPPL-24	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/20/1978	SUPPL-22	Manufacturing (CMC)-Packaging		Label is not available on this site.
05/07/1976	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
01/29/1976	SUPPL-19	Manufacturing (CMC)-Control		Label is not available on this site.
08/12/1975	SUPPL-18	Manufacturing (CMC)-Control		Label is not available on this site.
01/06/1975	SUPPL-17	Manufacturing (CMC)-Control		Label is not available on this site.
08/26/1974	SUPPL-16	Labeling		Label is not available on this site.
07/03/1974	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.