NDA 005490

ORGANON USA INC

FDA Drug Application

Application #005490

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
        )

)