Application Sponsors
ANDA 091416 | MARKSANS PHARMA | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | TABLET;ORAL | 250MG | 0 | NAPROXEN | NAPROXEN |
002 | TABLET;ORAL | 375MG | 0 | NAPROXEN | NAPROXEN |
003 | TABLET;ORAL | 500MG | 0 | NAPROXEN | NAPROXEN |
FDA Submissions
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
CDER Filings
MARKSANS PHARMA
cder:Array
(
[0] => Array
(
[ApplNo] => 91416
[companyName] => MARKSANS PHARMA
[docInserts] => ["",""]
[products] => [{"drugName":"NAPROXEN","activeIngredients":"NAPROXEN","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NAPROXEN","activeIngredients":"NAPROXEN","strength":"375MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NAPROXEN","activeIngredients":"NAPROXEN","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"NAPROXEN","submission":"NAPROXEN","actionType":"250MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"NAPROXEN","submission":"NAPROXEN","actionType":"375MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"NAPROXEN","submission":"NAPROXEN","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)