Home Applications 216993 Application 216993
Type NDA
Sponsor DAIICHI SANKYO INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 VANFLYTA QUIZARTINIB DIHYDROCHLORIDE TABLET;ORAL EQ 17.7MG BASE Yes No 002 VANFLYTA QUIZARTINIB DIHYDROCHLORIDE TABLET;ORAL EQ 26.5MG BASE Yes Yes
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 N216993-001 VANFLYTA QUIZARTINIB DIHYDROCHLORIDE EQ 17.7MG BASE TABLET / ORAL RLD 2023-07-20 N216993-002 VANFLYTA QUIZARTINIB DIHYDROCHLORIDE EQ 26.5MG BASE TABLET / ORAL RLD, RS 2023-07-20
Orange Book patents# Current patent rows page 1 of 1 · 22 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 4 matching rows.
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 · 44 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 N216993-001 VANFLYTA EQ 17.7MG BASE TABLET / ORAL RLD 2023-07-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216993-002 VANFLYTA EQ 26.5MG BASE TABLET / ORAL RLD, RS 2023-07-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 N216993-001 VANFLYTA EQ 17.7MG BASE TABLET / ORAL RLD 2023-07-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216993-002 VANFLYTA EQ 26.5MG BASE TABLET / ORAL RLD, RS 2023-07-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N216993-001 VANFLYTA EQ 17.7MG BASE TABLET / ORAL RLD 2023-07-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216993-002 VANFLYTA EQ 26.5MG BASE TABLET / ORAL RLD, RS 2023-07-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216993-001 VANFLYTA EQ 17.7MG BASE TABLET / ORAL RLD 2023-07-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216993-002 VANFLYTA EQ 26.5MG BASE TABLET / ORAL RLD, RS 2023-07-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216993-001 VANFLYTA EQ 17.7MG BASE TABLET / ORAL RLD 2023-07-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216993-002 VANFLYTA EQ 26.5MG BASE TABLET / ORAL RLD, RS 2023-07-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216993-001 VANFLYTA EQ 17.7MG BASE TABLET / ORAL RLD 2023-07-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216993-002 VANFLYTA EQ 26.5MG BASE TABLET / ORAL RLD, RS 2023-07-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216993-001 VANFLYTA EQ 17.7MG BASE TABLET / ORAL RLD 2023-07-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216993-002 VANFLYTA EQ 26.5MG BASE TABLET / ORAL RLD, RS 2023-07-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216993-001 VANFLYTA EQ 17.7MG BASE TABLET / ORAL RLD 2023-07-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216993-002 VANFLYTA EQ 26.5MG BASE TABLET / ORAL RLD, RS 2023-07-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216993-001 VANFLYTA EQ 17.7MG BASE TABLET / ORAL RLD 2023-07-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216993-002 VANFLYTA EQ 26.5MG BASE TABLET / ORAL RLD, RS 2023-07-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216993-001 VANFLYTA EQ 17.7MG BASE TABLET / ORAL RLD 2023-07-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216993-002 VANFLYTA EQ 26.5MG BASE TABLET / ORAL RLD, RS 2023-07-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216993-001 VANFLYTA EQ 17.7MG BASE TABLET / ORAL RLD 2023-07-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216993-002 VANFLYTA EQ 26.5MG BASE TABLET / ORAL RLD, RS 2023-07-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N216993-001 VANFLYTA EQ 17.7MG BASE TABLET / ORAL RLD 2023-07-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N216993-002 VANFLYTA EQ 26.5MG BASE TABLET / ORAL RLD, RS 2023-07-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216993-001 VANFLYTA EQ 17.7MG BASE TABLET / ORAL RLD 2023-07-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216993-002 VANFLYTA EQ 26.5MG BASE TABLET / ORAL RLD, RS 2023-07-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N216993-001 VANFLYTA EQ 17.7MG BASE TABLET / ORAL RLD 2023-07-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N216993-002 VANFLYTA EQ 26.5MG BASE TABLET / ORAL RLD, RS 2023-07-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N216993-001 VANFLYTA EQ 17.7MG BASE TABLET / ORAL RLD 2023-07-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N216993-002 VANFLYTA EQ 26.5MG BASE TABLET / ORAL RLD, RS 2023-07-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N216993-001 VANFLYTA EQ 17.7MG BASE TABLET / ORAL RLD 2023-07-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N216993-002 VANFLYTA EQ 26.5MG BASE TABLET / ORAL RLD, RS 2023-07-20 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N216993-001 VANFLYTA EQ 17.7MG BASE TABLET / ORAL RLD 2023-07-20 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N216993-002 VANFLYTA EQ 26.5MG BASE TABLET / ORAL RLD, RS 2023-07-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N216993-001 VANFLYTA EQ 17.7MG BASE TABLET / ORAL RLD 2023-07-20 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N216993-002 VANFLYTA EQ 26.5MG BASE TABLET / ORAL RLD, RS 2023-07-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N216993-001 VANFLYTA EQ 17.7MG BASE TABLET / ORAL RLD 2023-07-20 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N216993-002 VANFLYTA EQ 26.5MG BASE TABLET / ORAL RLD, RS 2023-07-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N216993-001 VANFLYTA EQ 17.7MG BASE TABLET / ORAL RLD 2023-07-20 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N216993-002 VANFLYTA EQ 26.5MG BASE TABLET / ORAL RLD, RS 2023-07-20 a72a2bbeb626…
Observed Orange Book patent history# Patent history page 1 of 13 · 484 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 N216993-001 8129374 2027-03-16 U-3661 2023-08-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216993-001 8557810 2027-03-16 Drug product 2023-08-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216993-001 8883783 2027-03-16 Drug substance 2023-08-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216993-001 9585892 2027-03-16 U-3661 2023-08-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216993-001 7820657 2028-09-26 Drug substance 2023-08-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216993-001 7968543 2029-08-15 U-3661 Drug product 2023-08-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216993-001 8865710 2029-08-15 Drug product 2023-08-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216993-001 8836218 2030-03-23 U-3661 2023-08-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216993-001 9555040 2030-05-14 U-3661 2023-08-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216993-001 8357690 2031-02-26 U-3661 2023-08-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216993-001 9675549 2033-09-30 Drug product 2023-08-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216993-002 8129374 2027-03-16 U-3661 2023-08-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216993-002 8557810 2027-03-16 Drug product 2023-08-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216993-002 8883783 2027-03-16 Drug substance 2023-08-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216993-002 9585892 2027-03-16 U-3661 2023-08-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216993-002 7820657 2028-09-26 Drug substance 2023-08-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216993-002 7968543 2029-08-15 U-3661 Drug product 2023-08-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216993-002 8865710 2029-08-15 Drug product 2023-08-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216993-002 8836218 2030-03-23 U-3661 2023-08-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216993-002 9555040 2030-05-14 U-3661 2023-08-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216993-002 8357690 2031-02-26 U-3661 2023-08-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216993-002 9675549 2033-09-30 Drug product 2023-08-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 N216993-001 8129374 2027-03-16 U-3661 2023-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216993-001 8557810 2027-03-16 Drug product 2023-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216993-001 8883783 2027-03-16 Drug substance 2023-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216993-001 9585892 2027-03-16 U-3661 2023-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216993-001 7820657 2028-09-26 Drug substance 2023-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216993-001 7968543 2029-08-15 U-3661 Drug product 2023-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216993-001 8865710 2029-08-15 Drug product 2023-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216993-001 8836218 2030-03-23 U-3661 2023-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216993-001 9555040 2030-05-14 U-3661 2023-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216993-001 8357690 2031-02-26 U-3661 2023-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216993-001 9675549 2033-09-30 Drug product 2023-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216993-002 8129374 2027-03-16 U-3661 2023-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216993-002 8557810 2027-03-16 Drug product 2023-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216993-002 8883783 2027-03-16 Drug substance 2023-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216993-002 9585892 2027-03-16 U-3661 2023-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216993-002 7820657 2028-09-26 Drug substance 2023-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216993-002 7968543 2029-08-15 U-3661 Drug product 2023-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216993-002 8865710 2029-08-15 Drug product 2023-08-11 caaa826d4ba7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 88 observed states.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join VANFLYTA QUIZARTINIB Daiichi Sankyo Inc. 29cdbcfe-497d-4e78-bb7b-2d4acafe8e86 2026-04-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 216993 application number: NDA216993
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 85791 SUPPL 2026-05-01 85687 SUPPL 2026-04-15 85684 SUPPL 2026-04-15 78925 SUPPL 2024-06-27 78900 SUPPL 2024-06-26 76272 ORIG 2023-11-03 75066 ORIG 2023-08-14 74845 ORIG 2023-07-21 74820 ORIG 2023-07-20 74819 ORIG 2023-07-20