FDA NDA · NDA018770
TORNALATE
Sponsor: SANOFI AVENTIS US
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APPLICATION
NDA018770
TYPE
NDA
ORIGINAL APPROVAL
1984-12-28
LATEST ACTION
2007-12-07
ROUTE
INHALATION
DOSAGE FORM
AEROSOL, METERED
MARKETING STATUS
Discontinued
Products
TORNALATEDiscontinued
BITOLTEROL MESYLATE 0.37MG/INH · AEROSOL, METERED · INHALATION
Approval history
2007-12-07Labeling · Supplement 8AP
2007-12-07Efficacy · Supplement 4AP
2007-12-07Labeling · Supplement 16 · standardAP
2007-12-07Labeling · Supplement 14 · standardAP
2007-12-07Labeling · Supplement 15 · standardAP
2007-12-07Efficacy · Supplement 11AP
1999-01-20Manufacturing (CMC) · Supplement 17 · standardAP
1994-04-11Manufacturing (CMC) · Supplement 12 · standardAP
1991-07-09Labeling · Supplement 13AP
1986-09-24Labeling · Supplement 10AP
1986-08-06Labeling · Supplement 7AP
1986-01-17Manufacturing (CMC) · Supplement 3 · standardAP
1986-01-09Labeling · Supplement 5AP
1985-08-14Manufacturing (CMC) · Supplement 2 · standardAP
1985-03-11Labeling · Supplement 1AP
1984-12-28Type 1 - New Molecular Entity · Original · standardAP
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