Application 206827
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CELECOXIB | CELECOXIB | CAPSULE;ORAL | 50MG | No | No |
| 002 | CELECOXIB | CELECOXIB | CAPSULE;ORAL | 100MG | No | No |
| 003 | CELECOXIB | CELECOXIB | CAPSULE;ORAL | 200MG | No | No |
| 004 | CELECOXIB | CELECOXIB | CAPSULE;ORAL | 400MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50090-2427 | Celecoxib | Celecoxib | A-S Medication Solutions | ANDA | Current |
| 55700-429 | Celecoxib | Celecoxib | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-430 | Celecoxib | Celecoxib | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 65862-907 | Celecoxib | Celecoxib | Aurobindo Pharma Limited | ANDA | Current |
| 65862-907 | Celecoxib | Celecoxib | Aurobindo Pharma Limited | ANDA | Current |
| 65862-907 | Celecoxib | Celecoxib | Aurobindo Pharma Limited | ANDA | Current |
| 65862-907 | Celecoxib | Celecoxib | Aurobindo Pharma Limited | ANDA | Current |
| 65862-907 | Celecoxib | Celecoxib | Aurobindo Pharma Limited | ANDA | Current |
| 65862-908 | Celecoxib | Celecoxib | Aurobindo Pharma Limited | ANDA | Current |
| 65862-908 | Celecoxib | Celecoxib | Aurobindo Pharma Limited | ANDA | Current |
| 65862-908 | Celecoxib | Celecoxib | Aurobindo Pharma Limited | ANDA | Current |
| 65862-908 | Celecoxib | Celecoxib | Aurobindo Pharma Limited | ANDA | Current |
| 65862-908 | Celecoxib | Celecoxib | Aurobindo Pharma Limited | ANDA | Current |
| 65862-909 | Celecoxib | Celecoxib | Aurobindo Pharma Limited | ANDA | Current |
| 65862-909 | Celecoxib | Celecoxib | Aurobindo Pharma Limited | ANDA | Current |
| 65862-909 | Celecoxib | Celecoxib | Aurobindo Pharma Limited | ANDA | Current |
| 65862-909 | Celecoxib | Celecoxib | Aurobindo Pharma Limited | ANDA | Current |
| 65862-909 | Celecoxib | Celecoxib | Aurobindo Pharma Limited | ANDA | Current |
| 65862-910 | Celecoxib | Celecoxib | Aurobindo Pharma Limited | ANDA | Current |
| 65862-910 | Celecoxib | Celecoxib | Aurobindo Pharma Limited | ANDA | Current |
| 65862-910 | Celecoxib | Celecoxib | Aurobindo Pharma Limited | ANDA | Current |
| 65862-910 | Celecoxib | Celecoxib | Aurobindo Pharma Limited | ANDA | Current |
| 65862-910 | Celecoxib | Celecoxib | Aurobindo Pharma Limited | ANDA | Current |
| 68788-6463 | Celecoxib | Celecoxib | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6463 | Celecoxib | Celecoxib | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70882-129 | Celecoxib | Celecoxib | Cambridge Therapeutics Technologies, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 40565 | ORIG | 2016-02-11 |
| 10596 | ORIG | 2016-02-03 |