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 44.

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.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N202570-001	ODE-328	2028-01-14
N202570-001	ODE-407	2029-07-14
N202570-002	ODE-328	2028-01-14
N202570-002	ODE-407	2029-07-14

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 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N202570-001	XALKORI	200MG	CAPSULE / ORAL	RLD	2011-08-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202570-002	XALKORI	250MG	CAPSULE / ORAL	RLD, RS	2011-08-26	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N202570-001	XALKORI	200MG	CAPSULE / ORAL	RLD	2011-08-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202570-002	XALKORI	250MG	CAPSULE / ORAL	RLD, RS	2011-08-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N202570-001	XALKORI	200MG	CAPSULE / ORAL	RLD	2011-08-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202570-002	XALKORI	250MG	CAPSULE / ORAL	RLD, RS	2011-08-26	`caaa826d4ba7…`
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…`

Observed Orange Book patent history#

Patent history page 1 of 14 · 554 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N202570-001	7825137	2027-05-12	U-3403		2011-09-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202570-001	7825137	2027-05-12	U-3058		2011-09-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202570-001	7825137	2027-05-12	U-3057		2011-09-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202570-001	7858643	2029-10-08		Drug substance, Drug product	2011-09-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202570-001	8217057	2029-11-06		Drug substance, Drug product	2012-07-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202570-002	7825137	2027-05-12	U-3403			`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202570-002	7825137	2027-05-12	U-3058			`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202570-002	7825137	2027-05-12	U-3057			`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202570-002	7858643	2029-10-08		Drug substance, Drug product		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N202570-002	8217057	2029-11-06		Drug substance, Drug product		`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N202570-001	7825137	2027-05-12	U-3403		2011-09-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202570-001	7825137	2027-05-12	U-3058		2011-09-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202570-001	7825137	2027-05-12	U-3057		2011-09-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202570-001	7858643	2029-10-08		Drug substance, Drug product	2011-09-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202570-001	8217057	2029-11-06		Drug substance, Drug product	2012-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202570-002	7825137	2027-05-12	U-3403			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202570-002	7825137	2027-05-12	U-3058			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202570-002	7825137	2027-05-12	U-3057			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202570-002	7858643	2029-10-08		Drug substance, Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202570-002	8217057	2029-11-06		Drug substance, Drug product		`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N202570-001	7825137	2027-05-12	U-3403		2011-09-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202570-001	7825137	2027-05-12	U-3058		2011-09-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202570-001	7825137	2027-05-12	U-3057		2011-09-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202570-001	7858643	2029-10-08		Drug substance, Drug product	2011-09-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202570-001	8217057	2029-11-06		Drug substance, Drug product	2012-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202570-002	7825137	2027-05-12	U-3403			`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202570-002	7825137	2027-05-12	U-3058			`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202570-002	7825137	2027-05-12	U-3057			`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202570-002	7858643	2029-10-08		Drug substance, Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202570-002	8217057	2029-11-06		Drug substance, Drug product		`caaa826d4ba7…`
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…`

Observed Orange Book exclusivity history#

Exclusivity history page 2 of 7 · 280 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202570-001	I-852	2024-01-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202570-001	I-897	2025-07-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202570-001	ODE-328	2028-01-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202570-001	ODE-407	2029-07-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202570-002	I-852	2024-01-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202570-002	I-897	2025-07-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202570-002	ODE-328	2028-01-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202570-002	ODE-407	2029-07-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202570-001	I-852	2024-01-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202570-001	I-897	2025-07-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202570-001	ODE-328	2028-01-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202570-001	ODE-407	2029-07-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202570-002	I-852	2024-01-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202570-002	I-897	2025-07-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202570-002	ODE-328	2028-01-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202570-002	ODE-407	2029-07-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202570-001	I-852	2024-01-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202570-001	I-897	2025-07-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202570-001	ODE-328	2028-01-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202570-001	ODE-407	2029-07-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202570-002	I-852	2024-01-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202570-002	I-897	2025-07-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202570-002	ODE-328	2028-01-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202570-002	ODE-407	2029-07-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202570-001	I-852	2024-01-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202570-001	I-897	2025-07-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202570-001	ODE-328	2028-01-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202570-001	ODE-407	2029-07-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202570-002	I-852	2024-01-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202570-002	I-897	2025-07-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202570-002	ODE-328	2028-01-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202570-002	ODE-407	2029-07-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202570-001	I-852	2024-01-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202570-001	I-897	2025-07-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202570-001	ODE-328	2028-01-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202570-001	ODE-407	2029-07-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202570-002	I-852	2024-01-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202570-002	I-897	2025-07-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202570-002	ODE-328	2028-01-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202570-002	ODE-407	2029-07-14	`d06236e962d9…`

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): 202570 application number: NDA202570 ndc (product): 0069-8141 ndc (product): 0069-8140

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 · 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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75464	SUPPL	2023-09-15
75374	SUPPL	2023-09-08
75370	SUPPL	2023-09-07
71558	SUPPL	2022-07-15
71546	SUPPL	2022-07-14
71545	SUPPL	2022-07-14
68819	SUPPL	2021-09-30
68818	SUPPL	2021-09-30
65931	SUPPL	2021-01-19
65910	SUPPL	2021-01-14
65909	SUPPL	2021-01-14
59183	SUPPL	2019-06-27
59171	SUPPL	2019-06-26
10073	ORIG	2018-12-20
56663	SUPPL	2018-12-07
56661	SUPPL	2018-12-07
56647	SUPPL	2018-12-07
56615	SUPPL	2018-12-03
52521	SUPPL	2018-02-08
52520	SUPPL	2018-02-08
52504	SUPPL	2018-02-08
49068	SUPPL	2017-07-25
49045	SUPPL	2017-07-25
48203	SUPPL	2017-05-02
48175	SUPPL	2017-05-01
47001	SUPPL	2017-01-27
46980	SUPPL	2017-01-24
45692	SUPPL	2016-10-28
10079	SUPPL	2016-05-04
40203	SUPPL	2016-05-03
10080	SUPPL	2016-05-02
40204	SUPPL	2016-04-29
19361	SUPPL	2016-03-11
40202	SUPPL	2015-09-23
32279	SUPPL	2015-09-16
19360	SUPPL	2015-03-24
10078	SUPPL	2015-03-24
32278	SUPPL	2014-06-02
40201	SUPPL	2014-05-30
32277	SUPPL	2013-11-25
40198	SUPPL	2013-11-22
40199	SUPPL	2013-10-08
10077	SUPPL	2013-10-08
10076	SUPPL	2013-10-08
40200	SUPPL	2013-10-07
40197	SUPPL	2013-03-15
10075	SUPPL	2013-03-01
40195	SUPPL	2012-03-15
32276	SUPPL	2012-02-29
10074	SUPPL	2012-02-29
40196	SUPPL	2012-02-28
44862	ORIG	2011-09-27
22892	ORIG	2011-09-27
19359	ORIG	2011-08-26