Application 210292
- Type
- ANDA
- Sponsor
- INDOCO REMEDIES
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FEBUXOSTAT | FEBUXOSTAT | TABLET;ORAL | 40MG | No | No |
| 002 | FEBUXOSTAT | FEBUXOSTAT | TABLET;ORAL | 80MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 14445-156 | Febuxostat | Febuxostat | Indoco Remedies Limited | ANDA | Current |
| 14445-157 | Febuxostat | Febuxostat | Indoco Remedies Limited | ANDA | Current |
| 27808-206 | Febuxostat | febuxostat | Tris Pharma Inc | ANDA | Current |
| 27808-206 | Febuxostat | febuxostat | Tris Pharma Inc | ANDA | Current |
| 27808-207 | Febuxostat | febuxostat | Tris Pharma Inc | ANDA | Current |
| 27808-207 | Febuxostat | febuxostat | Tris Pharma Inc | ANDA | Current |
| 71610-585 | Febuxostat | febuxostat | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |