Application Sponsors
NDA 019548 | SANOFI AVENTIS US | |
Marketing Status
Application Products
001 | SOLUTION;INHALATION | 0.2% | 0 | TORNALATE | BITOLTEROL MESYLATE |
FDA Submissions
TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1992-02-19 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1994-09-21 | STANDARD |
LABELING; Labeling | SUPPL | 3 | AP | 2007-12-07 | STANDARD |
LABELING; Labeling | SUPPL | 4 | AP | 2007-12-07 | STANDARD |
Submissions Property Types
CDER Filings
SANOFI AVENTIS US
cder:Array
(
[0] => Array
(
[ApplNo] => 19548
[companyName] => SANOFI AVENTIS US
[docInserts] => ["",""]
[products] => [{"drugName":"TORNALATE","activeIngredients":"BITOLTEROL MESYLATE","strength":"0.2%","dosageForm":"SOLUTION;INHALATION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"TORNALATE","submission":"BITOLTEROL MESYLATE","actionType":"0.2%","submissionClassification":"SOLUTION;INHALATION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)