Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 006008
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MESANTOIN MEPHENYTOIN 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
10/23/1946 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/02/2001 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

04/23/1999 SUPPL-48 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/15/1997 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

02/21/1996 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

02/15/1995 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

08/14/1995 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

12/14/1994 SUPPL-42 Labeling

Label is not available on this site.

12/14/1994 SUPPL-41 Labeling

Label is not available on this site.

11/23/1994 SUPPL-40 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/23/1996 SUPPL-39 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/01/1994 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

11/10/1987 SUPPL-35 Labeling

Label is not available on this site.

08/27/1986 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

12/05/1984 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

08/27/1986 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

08/08/1983 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

07/20/1981 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

03/06/1981 SUPPL-27 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/24/1980 SUPPL-26 Labeling

Label is not available on this site.

06/14/1979 SUPPL-25 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/28/1978 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/13/1978 SUPPL-23 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/18/1977 SUPPL-22 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/20/1976 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/23/1976 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/04/1976 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/04/1976 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

07/01/1975 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

11/10/1975 SUPPL-15 Labeling

Label is not available on this site.

09/20/1974 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

08/29/1974 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

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