Application Sponsors
| ANDA 091432 | SUNRISE PHARM INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 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 | 2011-09-19 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2015-05-04 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2019-11-25 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2019-11-25 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2019-11-25 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 9 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
NUVO PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 91432
[companyName] => NUVO PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"NAPROXEN","activeIngredients":"NAPROXEN","strength":"375MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NAPROXEN","activeIngredients":"NAPROXEN","strength":"500MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"NAPROXEN","submission":"NAPROXEN","actionType":"375MG","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"NAPROXEN","submission":"NAPROXEN","actionType":"500MG","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)