Application Sponsors
| ANDA 206136 | STRIDES PHARMA | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | CAPSULE;ORAL | 10MG | 0 | PIROXICAM | PIROXICAM |
| 002 | CAPSULE;ORAL | 20MG | 0 | PIROXICAM | PIROXICAM |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2017-06-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2018-07-23 | |
| LABELING; Labeling | SUPPL | 4 | AP | 2019-12-23 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 4 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
STRIDES PHARMA
cder:Array
(
[0] => Array
(
[ApplNo] => 206136
[companyName] => STRIDES PHARMA
[docInserts] => ["",""]
[products] => [{"drugName":"PIROXICAM","activeIngredients":"PIROXICAM","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PIROXICAM","activeIngredients":"PIROXICAM","strength":"20MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"06\/20\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"12\/23\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/23\/2018","submission":"SUPPL-3","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-12-23
)
)