Home Applications 212904 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
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table 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# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table 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# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table 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.
Product history page 1 of 2 · 72 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 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…2022-03-09 01:35 UTC 2022-03 N212904-001 FOTIVDA EQ 0.89MG BASE CAPSULE / ORAL RLD 2021-03-10 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N212904-002 FOTIVDA EQ 1.34MG BASE CAPSULE / ORAL RLD, RS 2021-03-10 bb7c543d1eb4…
Observed Orange Book patent history# Patent history page 1 of 5 · 186 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N212904-001 7166722 2028-11-16 Drug substance, Drug product 2021-04-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212904-001 11504365 2039-11-05 U-3476 2022-12-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212904-002 7166722 2028-11-16 Drug substance, Drug product 2021-04-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212904-002 11504365 2039-11-05 U-3476 2022-12-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 N212904-001 7166722 2028-11-16 Drug substance, Drug product 2021-04-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212904-001 11504365 2039-11-05 U-3476 2022-12-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212904-002 7166722 2028-11-16 Drug substance, Drug product 2021-04-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212904-002 11504365 2039-11-05 U-3476 2022-12-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N212904-001 7166722 2028-11-16 Drug substance, Drug product 2021-04-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212904-001 11504365 2039-11-05 U-3476 2022-12-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212904-002 7166722 2028-11-16 Drug substance, Drug product 2021-04-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212904-002 11504365 2039-11-05 U-3476 2022-12-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212904-001 6821987 2025-04-26 U-3100 Drug substance, Drug product 2021-04-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212904-001 7166722 2028-11-16 Drug substance, Drug product 2021-04-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212904-001 11504365 2039-11-05 U-3476 2022-12-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212904-002 6821987 2025-04-26 U-3100 Drug substance, Drug product 2021-04-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212904-002 7166722 2028-11-16 Drug substance, Drug product 2021-04-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212904-002 11504365 2039-11-05 U-3476 2022-12-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212904-001 6821987 2025-04-26 U-3100 Drug substance, Drug product 2021-04-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212904-001 7166722 2028-11-16 Drug substance, Drug product 2021-04-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212904-001 11504365 2039-11-05 U-3476 2022-12-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212904-002 6821987 2025-04-26 U-3100 Drug substance, Drug product 2021-04-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212904-002 7166722 2028-11-16 Drug substance, Drug product 2021-04-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212904-002 11504365 2039-11-05 U-3476 2022-12-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212904-001 6821987 2025-04-26 U-3100 Drug substance, Drug product 2021-04-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212904-001 7166722 2028-11-16 Drug substance, Drug product 2021-04-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212904-001 11504365 2039-11-05 U-3476 2022-12-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212904-002 6821987 2025-04-26 U-3100 Drug substance, Drug product 2021-04-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212904-002 7166722 2028-11-16 Drug substance, Drug product 2021-04-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212904-002 11504365 2039-11-05 U-3476 2022-12-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212904-001 6821987 2025-04-26 U-3100 Drug substance, Drug product 2021-04-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212904-001 11504365 2039-11-05 U-3476 2022-12-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212904-002 6821987 2025-04-26 U-3100 Drug substance, Drug product 2021-04-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212904-002 11504365 2039-11-05 U-3476 2022-12-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212904-001 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 N212904-001 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 N212904-001 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…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 70 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 4 matching rows.
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