Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Prescription | 004 |
Application Products
001 | CAPSULE;ORAL | 50MG | 0 | CELECOXIB | CELECOXIB |
002 | CAPSULE;ORAL | 100MG | 0 | CELECOXIB | CELECOXIB |
003 | CAPSULE;ORAL | 200MG | 0 | CELECOXIB | CELECOXIB |
004 | CAPSULE;ORAL | 400MG | 0 | CELECOXIB | CELECOXIB |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2015-12-23 | STANDARD |
LABELING; Labeling | SUPPL | 2 | AP | 2019-08-20 | STANDARD |
LABELING; Labeling | SUPPL | 3 | AP | 2019-08-20 | STANDARD |
LABELING; Labeling | SUPPL | 6 | AP | 2022-11-01 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 7 |
SUPPL | 2 | Null | 7 |
SUPPL | 3 | Null | 15 |
SUPPL | 6 | Null | 15 |
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
004 | Prescription | AB |
CDER Filings
TORRENT
cder:Array
(
[0] => Array
(
[ApplNo] => 207677
[companyName] => TORRENT
[docInserts] => ["",""]
[products] => [{"drugName":"CELECOXIB","activeIngredients":"CELECOXIB","strength":"50MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CELECOXIB","activeIngredients":"CELECOXIB","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CELECOXIB","activeIngredients":"CELECOXIB","strength":"200MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CELECOXIB","activeIngredients":"CELECOXIB","strength":"400MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"12\/23\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"08\/20\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/20\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/15\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-08-20
)
)