Application Sponsors
| ANDA 204519 | ALEMBIC PHARMS LTD | |
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 | 2015-08-21 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2016-09-16 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2019-09-18 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2019-09-18 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 7 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
| 004 | Prescription | AB |
CDER Filings
ALEMBIC PHARMS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 204519
[companyName] => ALEMBIC PHARMS LTD
[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":"08\/21\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"09\/18\/2019","submission":"SUPPL-7","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/18\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Medication Guide, Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/16\/2016","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-09-18
)
)