Application Sponsors
NDA 017668 | SANOFI AVENTIS US | |
Marketing Status
Application Products
001 | TABLET;ORAL | 25MG | 0 | TENUATE | DIETHYLPROPION HYDROCHLORIDE |
FDA Submissions
TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1975-03-20 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1976-03-10 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1976-09-24 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1976-09-24 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1978-04-27 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1979-11-02 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1980-05-12 | STANDARD |
LABELING; Labeling | SUPPL | 9 | AP | 1980-05-27 | |
LABELING; Labeling | SUPPL | 10 | AP | 1981-05-18 | |
Submissions Property Types
SUPPL | 2 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 4 | Null | 0 |
SUPPL | 6 | Null | 0 |
SUPPL | 7 | Null | 0 |
SUPPL | 8 | Null | 0 |
CDER Filings
SANOFI AVENTIS US
cder:Array
(
[0] => Array
(
[ApplNo] => 17668
[companyName] => SANOFI AVENTIS US
[docInserts] => ["",""]
[products] => [{"drugName":"TENUATE","activeIngredients":"DIETHYLPROPION HYDROCHLORIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"TENUATE","submission":"DIETHYLPROPION HYDROCHLORIDE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)