Application Sponsors
NDA 005490 | ORGANON USA INC | |
Marketing Status
Discontinued | 002 |
Discontinued | 003 |
Application Products
002 | TABLET;ORAL | 0.05MG | 0 | LYNORAL | ETHINYL ESTRADIOL |
003 | TABLET;ORAL | 0.01MG | 0 | LYNORAL | ETHINYL ESTRADIOL |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 1944-04-13 | UNKNOWN |
CDER Filings
ORGANON USA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 5490
[companyName] => ORGANON USA INC
[docInserts] => ["",""]
[products] => [{"drugName":"LYNORAL","activeIngredients":"ETHINYL ESTRADIOL","strength":"0.05MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LYNORAL","activeIngredients":"ETHINYL ESTRADIOL","strength":"0.01MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"LYNORAL","submission":"ETHINYL ESTRADIOL","actionType":"0.05MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LYNORAL","submission":"ETHINYL ESTRADIOL","actionType":"0.01MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)