Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017661
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TAVIST CLEMASTINE FUMARATE 2.68MG TABLET;ORAL Discontinued None Yes No
TAVIST-1 CLEMASTINE FUMARATE 1.34MG TABLET;ORAL Discontinued None No No
TAVIST-1 CLEMASTINE FUMARATE 1.34MG 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
02/25/1977 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
02/11/2002 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

06/06/1996 SUPPL-49 Manufacturing (CMC)-Control

Label is not available on this site.

10/31/1996 SUPPL-48 Efficacy-New Indication

Label is not available on this site.

10/20/1995 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

10/17/1995 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

11/07/1995 SUPPL-45 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/08/1994 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

02/03/1995 SUPPL-43 Labeling

Label is not available on this site.

07/21/1994 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

05/21/1993 SUPPL-41 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/22/1993 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/1992 SUPPL-38 Labeling

Label is not available on this site.

07/22/1992 SUPPL-36 Labeling

Label is not available on this site.

02/21/1991 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

09/08/1992 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

04/23/1992 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

03/04/1991 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

09/04/1992 SUPPL-31 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/04/1987 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

04/16/1986 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

08/21/1992 SUPPL-26 Efficacy-Rx To OTC Switch

Label is not available on this site.

04/15/1986 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/01/1983 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

07/15/1981 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

07/17/1981 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

05/01/1980 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

04/01/1980 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

04/17/1980 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

04/20/1979 SUPPL-16 Labeling

Label is not available on this site.

04/20/1979 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

10/14/1980 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

08/17/1978 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

08/11/1978 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

08/14/1978 SUPPL-11 Labeling

Label is not available on this site.

08/14/1978 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

05/30/1978 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

05/30/1978 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

05/24/1978 SUPPL-7 Labeling

Label is not available on this site.

03/16/1979 SUPPL-6 Labeling

Label is not available on this site.

03/16/1979 SUPPL-5 Efficacy

Label is not available on this site.

02/16/1978 SUPPL-4 Labeling

Label is not available on this site.

02/16/1978 SUPPL-3 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/16/1979 SUPPL-2 Manufacturing (CMC)-Formulation

Label is not available on this site.

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