Application Sponsors
ANDA 074116 | NOSTRUM LABS INC | |
Marketing Status
Application Products
001 | CAPSULE;ORAL | 10MG | 0 | PIROXICAM | PIROXICAM |
FDA Submissions
| ORIG | 1 | AP | 1993-06-15 | |
LABELING; Labeling | SUPPL | 3 | AP | 2011-10-26 | |
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 | 7 |
SUPPL | 8 | Null | 15 |
SUPPL | 9 | Null | 15 |
SUPPL | 10 | Null | 7 |
SUPPL | 12 | Null | 7 |
TE Codes
CDER Filings
cder:Array
(
[0] => Array
(
[ApplNo] => 74116
[companyName] =>
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)