Home Applications 217581 Application 217581
Type NDA
Sponsor PF PRISM CV Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 XALKORI CRIZOTINIB CAPSULE, PELLETS;ORAL 20MG Yes No 002 XALKORI CRIZOTINIB CAPSULE, PELLETS;ORAL 50MG Yes No 003 XALKORI CRIZOTINIB CAPSULE, PELLETS;ORAL 150MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N217581-001 XALKORI CRIZOTINIB 20MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 N217581-002 XALKORI CRIZOTINIB 50MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 N217581-003 XALKORI CRIZOTINIB 150MG CAPSULE, PELLETS / ORAL RLD, RS 2023-09-07
Orange Book patents# Current patent rows page 1 of 1 · 15 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N217581-001 7825137 2027-05-12 U-3057 2023-10-06 N217581-001 7825137 2027-05-12 U-3058 2023-10-06 N217581-001 7825137 2027-05-12 U-3403 2023-10-06 N217581-001 7858643 2029-10-08 Drug substance, Drug product 2023-10-06 N217581-001 8217057 2029-11-06 Drug substance 2023-10-06 N217581-002 7825137 2027-05-12 U-3057 2023-10-06 N217581-002 7825137 2027-05-12 U-3058 2023-10-06 N217581-002 7825137 2027-05-12 U-3403 2023-10-06 N217581-002 7858643 2029-10-08 Drug substance, Drug product 2023-10-06 N217581-002 8217057 2029-11-06 Drug substance 2023-10-06 N217581-003 7825137 2027-05-12 U-3057 2023-10-06 N217581-003 7825137 2027-05-12 U-3058 2023-10-06 N217581-003 7825137 2027-05-12 U-3403 2023-10-06 N217581-003 7858643 2029-10-08 Drug substance, Drug product 2023-10-06 N217581-003 8217057 2029-11-06 Drug substance 2023-10-06
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 · 60 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 2026-02-19 14:30 UTC 2026-02 N217581-001 XALKORI 20MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217581-002 XALKORI 50MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217581-003 XALKORI 150MG CAPSULE, PELLETS / ORAL RLD, RS 2023-09-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217581-001 XALKORI 20MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217581-002 XALKORI 50MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217581-003 XALKORI 150MG CAPSULE, PELLETS / ORAL RLD, RS 2023-09-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217581-001 XALKORI 20MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217581-002 XALKORI 50MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217581-003 XALKORI 150MG CAPSULE, PELLETS / ORAL RLD, RS 2023-09-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217581-001 XALKORI 20MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217581-002 XALKORI 50MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217581-003 XALKORI 150MG CAPSULE, PELLETS / ORAL RLD, RS 2023-09-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217581-001 XALKORI 20MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217581-002 XALKORI 50MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217581-003 XALKORI 150MG CAPSULE, PELLETS / ORAL RLD, RS 2023-09-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217581-001 XALKORI 20MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217581-002 XALKORI 50MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217581-003 XALKORI 150MG CAPSULE, PELLETS / ORAL RLD, RS 2023-09-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217581-001 XALKORI 20MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217581-002 XALKORI 50MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217581-003 XALKORI 150MG CAPSULE, PELLETS / ORAL RLD, RS 2023-09-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217581-001 XALKORI 20MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217581-002 XALKORI 50MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217581-003 XALKORI 150MG CAPSULE, PELLETS / ORAL RLD, RS 2023-09-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217581-001 XALKORI 20MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217581-002 XALKORI 50MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217581-003 XALKORI 150MG CAPSULE, PELLETS / ORAL RLD, RS 2023-09-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N217581-001 XALKORI 20MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N217581-002 XALKORI 50MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N217581-003 XALKORI 150MG CAPSULE, PELLETS / ORAL RLD, RS 2023-09-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217581-001 XALKORI 20MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217581-002 XALKORI 50MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217581-003 XALKORI 150MG CAPSULE, PELLETS / ORAL RLD, RS 2023-09-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217581-001 XALKORI 20MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217581-002 XALKORI 50MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217581-003 XALKORI 150MG CAPSULE, PELLETS / ORAL RLD, RS 2023-09-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217581-001 XALKORI 20MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217581-002 XALKORI 50MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217581-003 XALKORI 150MG CAPSULE, PELLETS / ORAL RLD, RS 2023-09-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N217581-001 XALKORI 20MG CAPSULE, PELLETS / ORAL RLD 2023-09-07 8072bd15b7f6…
Observed Orange Book patent history# Patent history page 1 of 11 · 408 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N217581-001 7825137 2027-05-12 U-3057 2023-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217581-001 7825137 2027-05-12 U-3403 2023-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217581-001 7825137 2027-05-12 U-3058 2023-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217581-001 7858643 2029-10-08 Drug substance, Drug product 2023-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217581-001 8217057 2029-11-06 Drug substance 2023-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217581-002 7825137 2027-05-12 U-3057 2023-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217581-002 7825137 2027-05-12 U-3058 2023-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217581-002 7825137 2027-05-12 U-3403 2023-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217581-002 7858643 2029-10-08 Drug substance, Drug product 2023-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217581-002 8217057 2029-11-06 Drug substance 2023-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217581-003 7825137 2027-05-12 U-3403 2023-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217581-003 7825137 2027-05-12 U-3057 2023-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217581-003 7825137 2027-05-12 U-3058 2023-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217581-003 7858643 2029-10-08 Drug substance, Drug product 2023-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217581-003 8217057 2029-11-06 Drug substance 2023-10-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217581-001 8785632 2025-03-01 Drug substance, Drug product 2023-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217581-001 7230098 2025-08-26 Drug substance 2023-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217581-001 7825137 2027-05-12 U-3057 2023-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217581-001 7825137 2027-05-12 U-3403 2023-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217581-001 7825137 2027-05-12 U-3058 2023-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217581-001 7858643 2029-10-08 Drug substance, Drug product 2023-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217581-001 8217057 2029-11-06 Drug substance 2023-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217581-002 8785632 2025-03-01 Drug substance, Drug product 2023-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217581-002 7230098 2025-08-26 Drug substance 2023-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217581-002 7825137 2027-05-12 U-3057 2023-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217581-002 7825137 2027-05-12 U-3058 2023-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217581-002 7825137 2027-05-12 U-3403 2023-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217581-002 7858643 2029-10-08 Drug substance, Drug product 2023-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217581-002 8217057 2029-11-06 Drug substance 2023-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217581-003 8785632 2025-03-01 Drug substance, Drug product 2023-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217581-003 7230098 2025-08-26 Drug substance 2023-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217581-003 7825137 2027-05-12 U-3403 2023-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217581-003 7825137 2027-05-12 U-3057 2023-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217581-003 7825137 2027-05-12 U-3058 2023-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217581-003 7858643 2029-10-08 Drug substance, Drug product 2023-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217581-003 8217057 2029-11-06 Drug substance 2023-10-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217581-001 8785632 2025-03-01 Drug substance, Drug product 2023-10-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217581-001 7230098 2025-08-26 Drug substance 2023-10-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217581-001 7825137 2027-05-12 U-3057 2023-10-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217581-001 7825137 2027-05-12 U-3403 2023-10-06 6a471c1ec25d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 84 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 Xalkori CRIZOTINIB Pfizer Laboratories Div Pfizer Inc 2a51b0de-47d6-455e-a94c-d2c737b04ff7 2025-07-22 Warnings, Adverse reactions Exact identifier application applno (NDA): 217581 application number: NDA217581
Documents# Document, Submission type, Date table Document Submission type Date 80847 ORIG 2025-01-14 80846 ORIG 2025-01-14 75376 ORIG 2023-09-08 75373 ORIG 2023-09-07