Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 011467
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRANCOPAL CHLORMEZANONE 100MG TABLET;ORAL Discontinued None No No
TRANCOPAL CHLORMEZANONE 200MG 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
05/20/1960 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
02/15/1995 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

06/08/1993 SUPPL-29 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/30/1993 SUPPL-28 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/25/1990 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

03/13/2009 SUPPL-25 Labeling

Label is not available on this site.

05/25/1993 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

01/20/1988 SUPPL-23 Labeling

Label is not available on this site.

03/13/2009 SUPPL-22 Labeling

Label is not available on this site.

10/29/1985 SUPPL-21 Labeling

Label is not available on this site.

01/28/1987 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

11/08/1991 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

08/22/1984 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

03/13/2009 SUPPL-17 Labeling

Label is not available on this site.

08/29/1984 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

01/24/1984 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

02/10/1981 SUPPL-12 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/17/1981 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

04/05/1979 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

04/04/1979 SUPPL-9 Labeling

Label is not available on this site.

03/13/2009 SUPPL-8 Labeling

Label is not available on this site.

12/14/1976 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

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