Documents
Application Sponsors
Marketing Status
Discontinued | 001 |
Discontinued | 002 |
Application Products
001 | TABLET, DELAYED RELEASE;ORAL | 375MG | 0 | NAPROXEN | NAPROXEN |
002 | TABLET, DELAYED RELEASE;ORAL | 500MG | 0 | NAPROXEN | NAPROXEN |
FDA Submissions
| ORIG | 1 | AP | 1999-05-26 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2002-07-01 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2002-07-01 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2002-07-01 | |
LABELING; Labeling | SUPPL | 5 | AP | 2006-02-17 | |
LABELING; Labeling | SUPPL | 9 | AP | 2006-07-03 | |
Submissions Property Types
SUPPL | 1 | Null | 0 |
SUPPL | 2 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 4 | Null | 0 |
CDER Filings
PLIVA
cder:Array
(
[0] => Array
(
[ApplNo] => 75337
[companyName] => PLIVA
[docInserts] => ["",""]
[products] => [{"drugName":"NAPROXEN","activeIngredients":"NAPROXEN","strength":"375MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NAPROXEN","activeIngredients":"NAPROXEN","strength":"500MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"NAPROXEN","submission":"NAPROXEN","actionType":"375MG","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"NAPROXEN","submission":"NAPROXEN","actionType":"500MG","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)