Application Sponsors
| ANDA 091305 | INVAGEN PHARMS | |
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
| ORIG | 1 | AP | 2011-08-24 | |
| LABELING; Labeling | SUPPL | 5 | AP | 2016-08-03 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2016-08-03 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2019-10-25 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2019-10-25 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 6 | Null | 15 |
| SUPPL | 11 | Null | 15 |
| SUPPL | 13 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
INVAGEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 91305
[companyName] => INVAGEN PHARMS
[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
)
)