Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012516
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SANSERT METHYSERGIDE MALEATE 2MG 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
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.

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