Application Sponsors
ANDA 212199 | SCIEGEN PHARMS INC | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | TABLET;ORAL | EQ 250MG BASE | 0 | NAPROXEN SODIUM | NAPROXEN SODIUM |
002 | TABLET;ORAL | EQ 500MG BASE | 0 | NAPROXEN SODIUM | NAPROXEN SODIUM |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2019-10-30 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
CDER Filings
SCIEGEN PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 212199
[companyName] => SCIEGEN PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"NAPROXEN SODIUM","activeIngredients":"NAPROXEN SODIUM","strength":"EQ 250MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NAPROXEN SODIUM","activeIngredients":"NAPROXEN SODIUM","strength":"EQ 500MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"10\/30\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2019-10-30
)
)