Application 212904
- Type
- NDA
- Sponsor
- AVEO PHARMACEUTICALS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FOTIVDA | TIVOZANIB | CAPSULE;ORAL | 0.89MG | Yes | No |
| 002 | FOTIVDA | TIVOZANIB | CAPSULE;ORAL | 1.34MG | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 45629-089 | FOTIVDA | Tivozanib | AVEO Pharmaceuticals, Inc. | NDA | Current |
| 45629-089 | FOTIVDA | Tivozanib | AVEO Pharmaceuticals, Inc. | NDA | Current |
| 45629-134 | FOTIVDA | Tivozanib | AVEO Pharmaceuticals, Inc. | NDA | Current |
| 45629-134 | FOTIVDA | Tivozanib | AVEO Pharmaceuticals, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 81096 | SUPPL | 2025-02-06 |
| 80969 | SUPPL | 2025-02-05 |
| 79336 | SUPPL | 2024-08-08 |
| 79334 | SUPPL | 2024-08-08 |
| 66993 | ORIG | 2021-04-06 |
| 66912 | ORIG | 2021-03-29 |
| 66745 | ORIG | 2021-03-11 |