Application 205467
- Type
- ANDA
- Sponsor
- SUN PHARM
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 |
|---|---|---|---|---|---|
| 16714-059 | Febuxostat | Febuxostat | NorthStar RxLLC | ANDA | Current |
| 16714-060 | Febuxostat | Febuxostat | NorthStar RxLLC | ANDA | Current |
| 47335-721 | Febuxostat | Febuxostat | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-722 | Febuxostat | Febuxostat | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 60687-538 | Febuxostat | Febuxostat | American Health Packaging | ANDA | Current |