APPLICATION
NDA019548
TYPE
NDA
ORIGINAL APPROVAL
1992-02-19
LATEST ACTION
2007-12-07
ROUTE
INHALATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
TORNALATEDiscontinued
BITOLTEROL MESYLATE 0.2% · SOLUTION · INHALATION
Approval history
2007-12-07Labeling · Supplement 3 · standardAP
2007-12-07Labeling · Supplement 4 · standardAP
1994-09-21Manufacturing (CMC) · Supplement 2 · standardAP
1994-02-02Labeling · Supplement 1 · standardAP
1992-02-19Type 3 - New Dosage Form · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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