Application Sponsors
NDA 011228 | ORGANON USA INC | |
Marketing Status
Application Products
001 | TABLET;ORAL | 3MG | 0 | LIQUAMAR | PHENPROCOUMON |
FDA Submissions
TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 1957-12-30 | STANDARD |
LABELING; Labeling | SUPPL | 6 | AP | 1978-11-29 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1978-11-29 | STANDARD |
LABELING; Labeling | SUPPL | 8 | AP | 1992-09-01 | |
Submissions Property Types
CDER Filings
ORGANON USA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 11228
[companyName] => ORGANON USA INC
[docInserts] => ["",""]
[products] => [{"drugName":"LIQUAMAR","activeIngredients":"PHENPROCOUMON","strength":"3MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"LIQUAMAR","submission":"PHENPROCOUMON","actionType":"3MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)