Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018770
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TORNALATE BITOLTEROL MESYLATE 0.37MG/INH AEROSOL, METERED;INHALATION 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
12/28/1984 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
01/20/1999 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/2007 SUPPL-16 Labeling

Label is not available on this site.

12/07/2007 SUPPL-15 Labeling

Label is not available on this site.

12/07/2007 SUPPL-14 Labeling

Label is not available on this site.

07/09/1991 SUPPL-13 Labeling

Label is not available on this site.

04/11/1994 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/2007 SUPPL-11 Efficacy-New Patient Population

Label is not available on this site.

09/24/1986 SUPPL-10 Labeling

Label is not available on this site.

12/07/2007 SUPPL-8 Labeling

Label is not available on this site.

08/06/1986 SUPPL-7 Labeling

Label is not available on this site.

01/09/1986 SUPPL-5 Labeling

Label is not available on this site.

12/07/2007 SUPPL-4 Efficacy-New Indication

Label is not available on this site.

01/17/1986 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

08/14/1985 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/11/1985 SUPPL-1 Labeling

Label is not available on this site.

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