Application 212904
- Type
- NDA
- Sponsor
- AVEO PHARMACEUTICALS INC
Application Products#
| 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 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N212904-001 | FOTIVDA | TIVOZANIB HYDROCHLORIDE | EQ 0.89MG BASE | CAPSULE / ORAL | RLD | 2021-03-10 | |
| N212904-002 | FOTIVDA | TIVOZANIB HYDROCHLORIDE | EQ 1.34MG BASE | CAPSULE / ORAL | RLD, RS | 2021-03-10 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N212904-001 | 7166722 | 2028-11-16 | Drug substance, Drug product | 2021-04-06 | |
| N212904-001 | 11504365 | 2039-11-05 | U-3476 | 2022-12-01 | |
| N212904-002 | 7166722 | 2028-11-16 | Drug substance, Drug product | 2021-04-06 | |
| N212904-002 | 11504365 | 2039-11-05 | U-3476 | 2022-12-01 |
Orange Book exclusivity#
| Application-product | Exclusivity code | Expiration |
|---|---|---|
| N212904-001 | NCE | 2026-03-10 |
| N212904-002 | NCE | 2026-03-10 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N212904-001 | FOTIVDA | EQ 0.89MG BASE | CAPSULE / ORAL | RLD | 2021-03-10 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N212904-002 | FOTIVDA | EQ 1.34MG BASE | CAPSULE / ORAL | RLD, RS | 2021-03-10 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N212904-001 | FOTIVDA | EQ 0.89MG BASE | CAPSULE / ORAL | RLD | 2021-03-10 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N212904-002 | FOTIVDA | EQ 1.34MG BASE | CAPSULE / ORAL | RLD, RS | 2021-03-10 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N212904-001 | FOTIVDA | EQ 0.89MG BASE | CAPSULE / ORAL | RLD | 2021-03-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N212904-002 | FOTIVDA | EQ 1.34MG BASE | CAPSULE / ORAL | RLD, RS | 2021-03-10 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N212904-001 | FOTIVDA | EQ 0.89MG BASE | CAPSULE / ORAL | RLD | 2021-03-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N212904-002 | FOTIVDA | EQ 1.34MG BASE | CAPSULE / ORAL | RLD, RS | 2021-03-10 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N212904-001 | FOTIVDA | EQ 0.89MG BASE | CAPSULE / ORAL | RLD | 2021-03-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N212904-002 | FOTIVDA | EQ 1.34MG BASE | CAPSULE / ORAL | RLD, RS | 2021-03-10 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N212904-001 | FOTIVDA | EQ 0.89MG BASE | CAPSULE / ORAL | RLD | 2021-03-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N212904-002 | FOTIVDA | EQ 1.34MG BASE | CAPSULE / ORAL | RLD, RS | 2021-03-10 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N212904-001 | FOTIVDA | EQ 0.89MG BASE | CAPSULE / ORAL | RLD | 2021-03-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N212904-002 | FOTIVDA | EQ 1.34MG BASE | CAPSULE / ORAL | RLD, RS | 2021-03-10 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N212904-001 | FOTIVDA | EQ 0.89MG BASE | CAPSULE / ORAL | RLD | 2021-03-10 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N212904-002 | FOTIVDA | EQ 1.34MG BASE | CAPSULE / ORAL | RLD, RS | 2021-03-10 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N212904-001 | FOTIVDA | EQ 0.89MG BASE | CAPSULE / ORAL | RLD | 2021-03-10 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N212904-002 | FOTIVDA | EQ 1.34MG BASE | CAPSULE / ORAL | RLD, RS | 2021-03-10 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N212904-001 | FOTIVDA | EQ 0.89MG BASE | CAPSULE / ORAL | RLD | 2021-03-10 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N212904-002 | FOTIVDA | EQ 1.34MG BASE | CAPSULE / ORAL | RLD, RS | 2021-03-10 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N212904-001 | FOTIVDA | EQ 0.89MG BASE | CAPSULE / ORAL | RLD | 2021-03-10 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N212904-002 | FOTIVDA | EQ 1.34MG BASE | CAPSULE / ORAL | RLD, RS | 2021-03-10 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N212904-001 | FOTIVDA | EQ 0.89MG BASE | CAPSULE / ORAL | RLD | 2021-03-10 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N212904-002 | FOTIVDA | EQ 1.34MG BASE | CAPSULE / ORAL | RLD, RS | 2021-03-10 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N212904-001 | FOTIVDA | EQ 0.89MG BASE | CAPSULE / ORAL | RLD | 2021-03-10 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N212904-002 | FOTIVDA | EQ 1.34MG BASE | CAPSULE / ORAL | RLD, RS | 2021-03-10 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N212904-001 | FOTIVDA | EQ 0.89MG BASE | CAPSULE / ORAL | RLD | 2021-03-10 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N212904-002 | FOTIVDA | EQ 1.34MG BASE | CAPSULE / ORAL | RLD, RS | 2021-03-10 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N212904-001 | FOTIVDA | EQ 0.89MG BASE | CAPSULE / ORAL | RLD | 2021-03-10 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N212904-002 | FOTIVDA | EQ 1.34MG BASE | CAPSULE / ORAL | RLD, RS | 2021-03-10 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N212904-001 | FOTIVDA | EQ 0.89MG BASE | CAPSULE / ORAL | RLD | 2021-03-10 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N212904-002 | FOTIVDA | EQ 1.34MG BASE | CAPSULE / ORAL | RLD, RS | 2021-03-10 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N212904-001 | FOTIVDA | EQ 0.89MG BASE | CAPSULE / ORAL | RLD | 2021-03-10 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N212904-002 | FOTIVDA | EQ 1.34MG BASE | CAPSULE / ORAL | RLD, RS | 2021-03-10 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N212904-001 | FOTIVDA | EQ 0.89MG BASE | CAPSULE / ORAL | RLD | 2021-03-10 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N212904-002 | FOTIVDA | EQ 1.34MG BASE | CAPSULE / ORAL | RLD, RS | 2021-03-10 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N212904-001 | FOTIVDA | EQ 0.89MG BASE | CAPSULE / ORAL | RLD | 2021-03-10 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N212904-002 | FOTIVDA | EQ 1.34MG BASE | CAPSULE / ORAL | RLD, RS | 2021-03-10 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N212904-001 | FOTIVDA | EQ 0.89MG BASE | CAPSULE / ORAL | RLD | 2021-03-10 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N212904-002 | FOTIVDA | EQ 1.34MG BASE | CAPSULE / ORAL | RLD, RS | 2021-03-10 | 4b0b4de00fa7… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N212904-001 | 11504365 | 2039-11-05 | U-3476 | 2022-12-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N212904-002 | 7166722 | 2024-11-16 | Drug substance, Drug product | 2021-04-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N212904-002 | 6821987 | 2025-04-26 | U-3100 | Drug substance, Drug product | 2021-04-06 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N212904-002 | 11504365 | 2039-11-05 | U-3476 | 2022-12-01 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N212904-001 | 7166722 | 2024-11-16 | Drug substance, Drug product | 2021-04-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N212904-001 | 6821987 | 2025-04-26 | U-3100 | Drug substance, Drug product | 2021-04-06 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N212904-001 | 11504365 | 2039-11-05 | U-3476 | 2022-12-01 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N212904-002 | 7166722 | 2024-11-16 | Drug substance, Drug product | 2021-04-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N212904-002 | 6821987 | 2025-04-26 | U-3100 | Drug substance, Drug product | 2021-04-06 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N212904-002 | 11504365 | 2039-11-05 | U-3476 | 2022-12-01 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N212904-001 | 7166722 | 2024-11-16 | Drug substance, Drug product | 2021-04-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N212904-001 | 6821987 | 2025-04-26 | U-3100 | Drug substance, Drug product | 2021-04-06 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N212904-001 | 11504365 | 2039-11-05 | U-3476 | 2022-12-01 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N212904-002 | 7166722 | 2024-11-16 | Drug substance, Drug product | 2021-04-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N212904-002 | 6821987 | 2025-04-26 | U-3100 | Drug substance, Drug product | 2021-04-06 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N212904-002 | 11504365 | 2039-11-05 | U-3476 | 2022-12-01 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N212904-001 | 7166722 | 2024-11-16 | Drug substance, Drug product | 2021-04-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N212904-001 | 6821987 | 2025-04-26 | U-3100 | Drug substance, Drug product | 2021-04-06 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N212904-001 | 11504365 | 2039-11-05 | U-3476 | 2022-12-01 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N212904-002 | 7166722 | 2024-11-16 | Drug substance, Drug product | 2021-04-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N212904-002 | 6821987 | 2025-04-26 | U-3100 | Drug substance, Drug product | 2021-04-06 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N212904-002 | 11504365 | 2039-11-05 | U-3476 | 2022-12-01 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N212904-001 | 7166722 | 2024-11-16 | Drug substance, Drug product | 2021-04-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N212904-001 | 6821987 | 2025-04-26 | U-3100 | Drug substance, Drug product | 2021-04-06 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N212904-001 | 11504365 | 2039-11-05 | U-3476 | 2022-12-01 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N212904-002 | 7166722 | 2024-11-16 | Drug substance, Drug product | 2021-04-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N212904-002 | 6821987 | 2025-04-26 | U-3100 | Drug substance, Drug product | 2021-04-06 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N212904-002 | 11504365 | 2039-11-05 | U-3476 | 2022-12-01 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N212904-001 | 7166722 | 2024-11-16 | Drug substance, Drug product | 2021-04-06 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N212904-001 | 6821987 | 2025-04-26 | U-3100 | Drug substance, Drug product | 2021-04-06 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N212904-001 | 11504365 | 2039-11-05 | U-3476 | 2022-12-01 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N212904-002 | 7166722 | 2024-11-16 | Drug substance, Drug product | 2021-04-06 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N212904-002 | 6821987 | 2025-04-26 | U-3100 | Drug substance, Drug product | 2021-04-06 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N212904-002 | 11504365 | 2039-11-05 | U-3476 | 2022-12-01 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N212904-001 | 7166722 | 2024-11-16 | Drug substance, Drug product | 2021-04-06 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N212904-001 | 6821987 | 2025-04-26 | U-3100 | Drug substance, Drug product | 2021-04-06 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N212904-001 | 11504365 | 2039-11-05 | U-3476 | 2022-12-01 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N212904-002 | 7166722 | 2024-11-16 | Drug substance, Drug product | 2021-04-06 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N212904-002 | 6821987 | 2025-04-26 | U-3100 | Drug substance, Drug product | 2021-04-06 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N212904-002 | 11504365 | 2039-11-05 | U-3476 | 2022-12-01 | 301d65b070ca… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N212904-001 | NCE | 2026-03-10 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N212904-002 | NCE | 2026-03-10 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | N212904-001 | NCE | 2026-03-10 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N212904-002 | NCE | 2026-03-10 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N212904-001 | NCE | 2026-03-10 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N212904-002 | NCE | 2026-03-10 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N212904-001 | NCE | 2026-03-10 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N212904-002 | NCE | 2026-03-10 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N212904-001 | NCE | 2026-03-10 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N212904-002 | NCE | 2026-03-10 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N212904-001 | NCE | 2026-03-10 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N212904-002 | NCE | 2026-03-10 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N212904-001 | NCE | 2026-03-10 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N212904-002 | NCE | 2026-03-10 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N212904-001 | NCE | 2026-03-10 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N212904-002 | NCE | 2026-03-10 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N212904-001 | NCE | 2026-03-10 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N212904-002 | NCE | 2026-03-10 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N212904-001 | NCE | 2026-03-10 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N212904-002 | NCE | 2026-03-10 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N212904-001 | NCE | 2026-03-10 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N212904-002 | NCE | 2026-03-10 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N212904-001 | NCE | 2026-03-10 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N212904-002 | NCE | 2026-03-10 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N212904-001 | NCE | 2026-03-10 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N212904-002 | NCE | 2026-03-10 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N212904-001 | NCE | 2026-03-10 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N212904-002 | NCE | 2026-03-10 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N212904-001 | NCE | 2026-03-10 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N212904-002 | NCE | 2026-03-10 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N212904-001 | NCE | 2026-03-10 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N212904-002 | NCE | 2026-03-10 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N212904-001 | NCE | 2026-03-10 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N212904-002 | NCE | 2026-03-10 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N212904-001 | NCE | 2026-03-10 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N212904-002 | NCE | 2026-03-10 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N212904-001 | NCE | 2026-03-10 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N212904-002 | NCE | 2026-03-10 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N212904-001 | NCE | 2026-03-10 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N212904-002 | NCE | 2026-03-10 | 4b0b4de00fa7… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| 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 |