Application Sponsors
ANDA 074118 | NOSTRUM LABS INC | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | CAPSULE;ORAL | 20MG | 0 | PIROXICAM | PIROXICAM |
002 | CAPSULE;ORAL | 10MG | 0 | PIROXICAM | PIROXICAM |
FDA Submissions
| ORIG | 1 | AP | 1993-06-15 | |
LABELING; Labeling | SUPPL | 3 | AP | 2011-10-21 | |
LABELING; Labeling | SUPPL | 4 | AP | 2011-09-14 | |
LABELING; Labeling | SUPPL | 5 | AP | 2015-06-30 | STANDARD |
LABELING; Labeling | SUPPL | 8 | AP | 2015-06-30 | STANDARD |
LABELING; Labeling | SUPPL | 9 | AP | 2015-06-30 | STANDARD |
LABELING; Labeling | SUPPL | 10 | AP | 2019-12-23 | STANDARD |
LABELING; Labeling | SUPPL | 12 | AP | 2019-12-23 | STANDARD |
Submissions Property Types
SUPPL | 3 | Null | 15 |
SUPPL | 4 | Null | 15 |
SUPPL | 5 | Null | 15 |
SUPPL | 8 | Null | 7 |
SUPPL | 9 | Null | 7 |
SUPPL | 10 | Null | 15 |
SUPPL | 12 | Null | 7 |
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
CDER Filings
NOSTRUM LABS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 74118
[companyName] => NOSTRUM LABS INC
[docInserts] => ["",""]
[products] => [{"drugName":"PIROXICAM","activeIngredients":"PIROXICAM","strength":"20MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PIROXICAM","activeIngredients":"PIROXICAM","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"PIROXICAM","submission":"PIROXICAM","actionType":"20MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"PIROXICAM","submission":"PIROXICAM","actionType":"10MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)