Orange Book product · Brand (NDA)
TORNALATE
BITOLTEROL MESYLATE
Brand (NDA)NDA 019548DISCN SANOFI AVENTIS US
At a glance
Feb 19, 1992
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 19, 1992
34 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
BITOLTEROL MESYLATE
Strength
0.2%
Dosage form
SOLUTION
Route
INHALATION
TE code
Not listed
Application
NDA 019548
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
