Application Sponsors
Marketing Status
Application Products
001 | TABLET;ORAL | 200MG | 0 | IBUPRIN | IBUPROFEN |
FDA Submissions
| ORIG | 1 | AP | 1987-07-16 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1988-01-11 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1988-01-11 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1994-05-11 | |
Submissions Property Types
SUPPL | 1 | Null | 0 |
SUPPL | 2 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 7 | Null | 0 |
CDER Filings
PLIVA
cder:Array
(
[0] => Array
(
[ApplNo] => 71773
[companyName] => PLIVA
[docInserts] => ["",""]
[products] => [{"drugName":"IBUPRIN","activeIngredients":"IBUPROFEN","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"IBUPRIN","submission":"IBUPROFEN","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)