Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018770
Company: SANOFI AVENTIS US

Products on NDA 018770

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018770

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.