Application 205421
- Type
- ANDA
- Sponsor
- ALEMBIC PHARMS LTD
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 46708-190 | Febuxostat | febuxostat | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-191 | Febuxostat | febuxostat | Alembic Pharmaceuticals Limited | ANDA | Current |
| 62332-190 | Febuxostat | febuxostat | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-190 | Febuxostat | febuxostat | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-190 | Febuxostat | febuxostat | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-191 | Febuxostat | febuxostat | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-191 | Febuxostat | febuxostat | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-191 | Febuxostat | febuxostat | Alembic Pharmaceuticals Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 32670 | ORIG | 2016-07-05 |