Home Applications 202570 Application 202570
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;ORAL 200MG Yes No 002 XALKORI CRIZOTINIB CAPSULE;ORAL 250MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N202570-001 XALKORI CRIZOTINIB 200MG CAPSULE / ORAL RLD 2011-08-26 N202570-002 XALKORI CRIZOTINIB 250MG CAPSULE / ORAL RLD, RS 2011-08-26
Orange Book patents# Current patent rows page 1 of 1 · 10 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N202570-001 7825137 2027-05-12 U-3057 2011-09-14 N202570-001 7825137 2027-05-12 U-3058 2011-09-14 N202570-001 7825137 2027-05-12 U-3403 2011-09-14 N202570-001 7858643 2029-10-08 Drug substance, Drug product 2011-09-14 N202570-001 8217057 2029-11-06 Drug substance, Drug product 2012-07-31 N202570-002 7825137 2027-05-12 U-3057 N202570-002 7825137 2027-05-12 U-3058 N202570-002 7825137 2027-05-12 U-3403 N202570-002 7858643 2029-10-08 Drug substance, Drug product N202570-002 8217057 2029-11-06 Drug substance, Drug product
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 3 · 82 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 N202570-001 XALKORI 200MG CAPSULE / ORAL RLD 2011-08-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202570-002 XALKORI 250MG CAPSULE / ORAL RLD, RS 2011-08-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202570-001 XALKORI 200MG CAPSULE / ORAL RLD 2011-08-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202570-002 XALKORI 250MG CAPSULE / ORAL RLD, RS 2011-08-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202570-001 XALKORI 200MG CAPSULE / ORAL RLD 2011-08-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202570-002 XALKORI 250MG CAPSULE / ORAL RLD, RS 2011-08-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202570-001 XALKORI 200MG CAPSULE / ORAL RLD 2011-08-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202570-002 XALKORI 250MG CAPSULE / ORAL RLD, RS 2011-08-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202570-001 XALKORI 200MG CAPSULE / ORAL RLD 2011-08-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202570-002 XALKORI 250MG CAPSULE / ORAL RLD, RS 2011-08-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202570-001 XALKORI 200MG CAPSULE / ORAL RLD 2011-08-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202570-002 XALKORI 250MG CAPSULE / ORAL RLD, RS 2011-08-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202570-001 XALKORI 200MG CAPSULE / ORAL RLD 2011-08-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202570-002 XALKORI 250MG CAPSULE / ORAL RLD, RS 2011-08-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202570-001 XALKORI 200MG CAPSULE / ORAL RLD 2011-08-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202570-002 XALKORI 250MG CAPSULE / ORAL RLD, RS 2011-08-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202570-001 XALKORI 200MG CAPSULE / ORAL RLD 2011-08-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202570-002 XALKORI 250MG CAPSULE / ORAL RLD, RS 2011-08-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N202570-001 XALKORI 200MG CAPSULE / ORAL RLD 2011-08-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N202570-002 XALKORI 250MG CAPSULE / ORAL RLD, RS 2011-08-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202570-001 XALKORI 200MG CAPSULE / ORAL RLD 2011-08-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202570-002 XALKORI 250MG CAPSULE / ORAL RLD, RS 2011-08-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202570-001 XALKORI 200MG CAPSULE / ORAL RLD 2011-08-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202570-002 XALKORI 250MG CAPSULE / ORAL RLD, RS 2011-08-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202570-001 XALKORI 200MG CAPSULE / ORAL RLD 2011-08-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202570-002 XALKORI 250MG CAPSULE / ORAL RLD, RS 2011-08-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N202570-001 XALKORI 200MG CAPSULE / ORAL RLD 2011-08-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N202570-002 XALKORI 250MG CAPSULE / ORAL RLD, RS 2011-08-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202570-001 XALKORI 200MG CAPSULE / ORAL RLD 2011-08-26 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202570-002 XALKORI 250MG CAPSULE / ORAL RLD, RS 2011-08-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N202570-001 XALKORI 200MG CAPSULE / ORAL RLD 2011-08-26 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N202570-002 XALKORI 250MG CAPSULE / ORAL RLD, RS 2011-08-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N202570-001 XALKORI 200MG CAPSULE / ORAL RLD 2011-08-26 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N202570-002 XALKORI 250MG CAPSULE / ORAL RLD, RS 2011-08-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N202570-001 XALKORI 200MG CAPSULE / ORAL RLD 2011-08-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N202570-002 XALKORI 250MG CAPSULE / ORAL RLD, RS 2011-08-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N202570-001 XALKORI 200MG CAPSULE / ORAL RLD 2011-08-26 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N202570-002 XALKORI 250MG CAPSULE / ORAL RLD, RS 2011-08-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N202570-001 XALKORI 200MG CAPSULE / ORAL RLD 2011-08-26 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N202570-002 XALKORI 250MG CAPSULE / ORAL RLD, RS 2011-08-26 782e0a99824c…
Observed Orange Book patent history# Patent history page 1 of 14 · 524 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 N202570-001 7825137 2027-05-12 U-3403 2011-09-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202570-001 7825137 2027-05-12 U-3058 2011-09-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202570-001 7825137 2027-05-12 U-3057 2011-09-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202570-001 7858643 2029-10-08 Drug substance, Drug product 2011-09-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202570-001 8217057 2029-11-06 Drug substance, Drug product 2012-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202570-002 7825137 2027-05-12 U-3403 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202570-002 7825137 2027-05-12 U-3058 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202570-002 7825137 2027-05-12 U-3057 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202570-002 7858643 2029-10-08 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202570-002 8217057 2029-11-06 Drug substance, Drug product 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202570-001 8785632 2025-03-01 Drug substance 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202570-001 7230098 2025-08-26 Drug substance 2011-09-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202570-001 7825137 2027-05-12 U-3403 2011-09-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202570-001 7825137 2027-05-12 U-3058 2011-09-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202570-001 7825137 2027-05-12 U-3057 2011-09-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202570-001 7858643 2029-10-08 Drug substance, Drug product 2011-09-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202570-001 8217057 2029-11-06 Drug substance, Drug product 2012-07-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202570-002 8785632 2025-03-01 Drug substance 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202570-002 7230098 2025-08-26 Drug substance 2011-09-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202570-002 7825137 2027-05-12 U-3403 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202570-002 7825137 2027-05-12 U-3058 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202570-002 7825137 2027-05-12 U-3057 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202570-002 7858643 2029-10-08 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202570-002 8217057 2029-11-06 Drug substance, Drug product 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202570-001 8785632 2025-03-01 Drug substance 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202570-001 7230098 2025-08-26 Drug substance 2011-09-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202570-001 7825137 2027-05-12 U-3403 2011-09-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202570-001 7825137 2027-05-12 U-3058 2011-09-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202570-001 7825137 2027-05-12 U-3057 2011-09-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202570-001 7858643 2029-10-08 Drug substance, Drug product 2011-09-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202570-001 8217057 2029-11-06 Drug substance, Drug product 2012-07-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202570-002 8785632 2025-03-01 Drug substance 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202570-002 7230098 2025-08-26 Drug substance 2011-09-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202570-002 7825137 2027-05-12 U-3403 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202570-002 7825137 2027-05-12 U-3058 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202570-002 7825137 2027-05-12 U-3057 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202570-002 7858643 2029-10-08 Drug substance, Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202570-002 8217057 2029-11-06 Drug substance, Drug product 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202570-001 8785632 2025-03-01 Drug substance fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202570-001 7230098 2025-08-26 Drug substance 2011-09-14 fd3edfee7708…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 7 · 268 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 20 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0069-8140 Xalkori CRIZOTINIB Pfizer Laboratories Div Pfizer Inc NDA Current 0069-8140 Xalkori CRIZOTINIB Pfizer Laboratories Div Pfizer Inc NDA Current 0069-8140 Xalkori CRIZOTINIB Pfizer Laboratories Div Pfizer Inc NDA Current 0069-8140 Xalkori CRIZOTINIB Pfizer Laboratories Div Pfizer Inc NDA Current 0069-8140 Xalkori CRIZOTINIB Pfizer Laboratories Div Pfizer Inc NDA Current 0069-8140 Xalkori CRIZOTINIB Pfizer Laboratories Div Pfizer Inc NDA Current 0069-8140 Xalkori CRIZOTINIB Pfizer Laboratories Div Pfizer Inc NDA Current 0069-8140 Xalkori CRIZOTINIB Pfizer Laboratories Div Pfizer Inc NDA Current 0069-8140 Xalkori CRIZOTINIB Pfizer Laboratories Div Pfizer Inc NDA Current 0069-8140 Xalkori CRIZOTINIB Pfizer Laboratories Div Pfizer Inc NDA Current 0069-8141 Xalkori CRIZOTINIB Pfizer Laboratories Div Pfizer Inc NDA Current 0069-8141 Xalkori CRIZOTINIB Pfizer Laboratories Div Pfizer Inc NDA Current 0069-8141 Xalkori CRIZOTINIB Pfizer Laboratories Div Pfizer Inc NDA Current 0069-8141 Xalkori CRIZOTINIB Pfizer Laboratories Div Pfizer Inc NDA Current 0069-8141 Xalkori CRIZOTINIB Pfizer Laboratories Div Pfizer Inc NDA Current 0069-8141 Xalkori CRIZOTINIB Pfizer Laboratories Div Pfizer Inc NDA Current 0069-8141 Xalkori CRIZOTINIB Pfizer Laboratories Div Pfizer Inc NDA Current 0069-8141 Xalkori CRIZOTINIB Pfizer Laboratories Div Pfizer Inc NDA Current 0069-8141 Xalkori CRIZOTINIB Pfizer Laboratories Div Pfizer Inc NDA Current 0069-8141 Xalkori CRIZOTINIB Pfizer Laboratories Div Pfizer Inc NDA Current