Application 203214

Type: NDA
Sponsor: PF PRISM CV

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	XELJANZ	TOFACITINIB CITRATE	TABLET;ORAL	EQ 5MG BASE	Yes	No
002	XELJANZ	TOFACITINIB CITRATE	TABLET;ORAL	EQ 10MG BASE	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
N203214-001	XELJANZ	TOFACITINIB CITRATE	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2012-11-06
N203214-002	XELJANZ	TOFACITINIB CITRATE	EQ 10MG BASE	TABLET / ORAL	AB	RLD, RS	2018-05-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N203214-001	AB
N203214-002	AB

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N203214-001	RE41783	2025-12-08	Drug substance	2012-11-30
N203214-001	RE41783*PED	2026-06-08	Pediatric extension
N203214-002	RE41783	2025-12-08	Drug substance	2018-06-28
N203214-002	RE41783*PED	2026-06-08	Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N203214-001	M-14	2028-02-21
N203214-001	PED	2028-08-21

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N203214-001	XELJANZ	EQ 5MG BASE	TABLET / ORAL	RLD	2012-11-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203214-002	XELJANZ	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-05-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203214-001	XELJANZ	EQ 5MG BASE	TABLET / ORAL	RLD	2012-11-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203214-002	XELJANZ	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-05-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203214-001	XELJANZ	EQ 5MG BASE	TABLET / ORAL	RLD	2012-11-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203214-002	XELJANZ	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-05-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203214-001	XELJANZ	EQ 5MG BASE	TABLET / ORAL	RLD	2012-11-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203214-002	XELJANZ	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-05-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203214-001	XELJANZ	EQ 5MG BASE	TABLET / ORAL	RLD	2012-11-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203214-002	XELJANZ	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-05-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203214-001	XELJANZ	EQ 5MG BASE	TABLET / ORAL	RLD	2012-11-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203214-002	XELJANZ	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-05-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203214-001	XELJANZ	EQ 5MG BASE	TABLET / ORAL	RLD	2012-11-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203214-002	XELJANZ	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-05-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203214-001	XELJANZ	EQ 5MG BASE	TABLET / ORAL	RLD	2012-11-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203214-002	XELJANZ	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-05-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203214-001	XELJANZ	EQ 5MG BASE	TABLET / ORAL	RLD	2012-11-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203214-002	XELJANZ	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-05-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203214-001	XELJANZ	EQ 5MG BASE	TABLET / ORAL	RLD	2012-11-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203214-002	XELJANZ	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-05-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203214-001	XELJANZ	EQ 5MG BASE	TABLET / ORAL	RLD	2012-11-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203214-002	XELJANZ	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-05-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203214-001	XELJANZ	EQ 5MG BASE	TABLET / ORAL	RLD	2012-11-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203214-002	XELJANZ	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-05-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203214-001	XELJANZ	EQ 5MG BASE	TABLET / ORAL	RLD	2012-11-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203214-002	XELJANZ	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-05-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203214-001	XELJANZ	EQ 5MG BASE	TABLET / ORAL	RLD	2012-11-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N203214-002	XELJANZ	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-05-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203214-001	XELJANZ	EQ 5MG BASE	TABLET / ORAL	RLD	2012-11-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203214-002	XELJANZ	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-05-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203214-001	XELJANZ	EQ 5MG BASE	TABLET / ORAL	RLD	2012-11-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203214-002	XELJANZ	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-05-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203214-001	XELJANZ	EQ 5MG BASE	TABLET / ORAL	RLD	2012-11-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N203214-002	XELJANZ	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-05-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N203214-001	XELJANZ	EQ 5MG BASE	TABLET / ORAL	RLD	2012-11-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203214-002	XELJANZ	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-05-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203214-001	XELJANZ	EQ 5MG BASE	TABLET / ORAL	RLD	2012-11-06	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N203214-002	XELJANZ	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-05-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203214-001	XELJANZ	EQ 5MG BASE	TABLET / ORAL	RLD	2012-11-06	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N203214-002	XELJANZ	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-05-30	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N203214-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N203214-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N203214-001	AB	1	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N203214-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N203214-002	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 194 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N203214-001	RE41783	2025-12-08	Drug substance	2012-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203214-001	RE41783*PED	2026-06-08	Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203214-002	RE41783	2025-12-08	Drug substance	2018-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203214-002	RE41783*PED	2026-06-08	Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203214-001	RE41783	2025-12-08	Drug substance	2012-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203214-001	RE41783*PED	2026-06-08	Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203214-002	RE41783	2025-12-08	Drug substance	2018-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203214-002	RE41783*PED	2026-06-08	Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203214-001	RE41783	2025-12-08	Drug substance	2012-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203214-001	RE41783*PED	2026-06-08	Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203214-002	RE41783	2025-12-08	Drug substance	2018-06-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203214-002	RE41783*PED	2026-06-08	Pediatric extension		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203214-001	RE41783	2025-12-08	Drug substance	2012-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203214-001	RE41783*PED	2026-06-08	Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203214-002	RE41783	2025-12-08	Drug substance	2018-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203214-002	RE41783*PED	2026-06-08	Pediatric extension		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203214-001	RE41783	2025-12-08	Drug substance	2012-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203214-002	RE41783	2025-12-08	Drug substance	2018-06-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203214-001	RE41783	2025-12-08	Drug substance	2012-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203214-002	RE41783	2025-12-08	Drug substance	2018-06-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203214-001	RE41783	2025-12-08	Drug substance	2012-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203214-002	RE41783	2025-12-08	Drug substance	2018-06-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203214-001	RE41783	2025-12-08	Drug substance	2012-11-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203214-002	RE41783	2025-12-08	Drug substance	2018-06-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203214-001	RE41783	2025-12-08	Drug substance	2012-11-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203214-002	RE41783	2025-12-08	Drug substance	2018-06-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203214-001	RE41783	2025-12-08	Drug substance	2012-11-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203214-002	RE41783	2025-12-08	Drug substance	2018-06-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203214-001	RE41783	2025-12-08	Drug substance	2012-11-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203214-002	RE41783	2025-12-08	Drug substance	2018-06-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203214-001	RE41783	2025-12-08	Drug substance	2012-11-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203214-002	RE41783	2025-12-08	Drug substance	2018-06-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203214-001	RE41783	2025-12-08	Drug substance	2012-11-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203214-002	RE41783	2025-12-08	Drug substance	2018-06-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203214-001	RE41783	2025-12-08	Drug substance	2012-11-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N203214-002	RE41783	2025-12-08	Drug substance	2018-06-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203214-001	6965027	2023-03-25	Drug substance	2012-11-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203214-001	RE41783	2025-12-08	Drug substance	2012-11-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203214-002	6965027	2023-03-25	Drug substance	2018-06-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203214-002	RE41783	2025-12-08	Drug substance	2018-06-28	`5c6f7cd8ea54…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 103 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N203214-001	M-14	2028-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203214-001	PED	2028-08-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203214-001	M-14	2028-02-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203214-001	PED	2028-08-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203214-001	M-14	2028-02-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203214-001	PED	2028-08-21	`6a471c1ec25d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203214-001	I-879	2024-12-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203214-002	I-879	2024-12-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203214-001	I-879	2024-12-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203214-002	I-879	2024-12-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203214-001	I-879	2024-12-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203214-002	I-879	2024-12-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203214-001	I-879	2024-12-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203214-002	I-879	2024-12-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203214-001	I-879	2024-12-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203214-002	I-879	2024-12-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203214-001	I-879	2024-12-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203214-002	I-879	2024-12-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203214-001	I-879	2024-12-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203214-002	I-879	2024-12-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203214-001	I-879	2024-12-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203214-002	I-879	2024-12-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203214-001	I-879	2024-12-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N203214-002	I-879	2024-12-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203214-001	NPP	2023-09-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203214-001	I-879	2024-12-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203214-002	I-879	2024-12-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203214-001	NPP	2023-09-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203214-001	I-879	2024-12-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203214-002	I-879	2024-12-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203214-001	NPP	2023-09-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N203214-001	I-879	2024-12-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N203214-002	I-879	2024-12-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N203214-001	I-761	2020-12-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203214-001	I-780	2021-05-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203214-002	I-780	2021-05-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203214-001	NPP	2023-09-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N203214-001	I-879	2024-12-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N203214-002	I-879	2024-12-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203214-001	I-780	2021-05-30	`782e0a99824c…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
XELJANZ	TOFACITINIB	U.S. Pharmaceuticals	68e3d6b2-7838-4d2d-a417-09d919b43e13	2026-07-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 203214 application number: NDA203214 ndc (product): 63539-012 ndc (product): 63539-016
XELJANZ XR	TOFACITINIB	Pfizer Laboratories Div Pfizer Inc	cf74ba2f-afc5-4baa-8594-979c889a5831	2026-07-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 203214 application number: NDA203214 ndc (product): 0069-1001 ndc (product): 0069-1002

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 42 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0069-1001	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1001	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1001	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1001	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1001	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1001	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1001	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1001	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1001	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1001	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1001	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1001	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1001	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1001	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1001	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1002	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1002	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1002	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1002	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1002	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1002	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1002	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1002	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1002	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1002	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1002	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1002	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1002	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1002	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1002	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
63539-012	XELJANZ	tofacitinib	U.S. Pharmaceuticals	NDA	Current
63539-012	XELJANZ	tofacitinib	U.S. Pharmaceuticals	NDA	Current
63539-012	XELJANZ	tofacitinib	U.S. Pharmaceuticals	NDA	Current
63539-012	XELJANZ	tofacitinib	U.S. Pharmaceuticals	NDA	Current
63539-012	XELJANZ	tofacitinib	U.S. Pharmaceuticals	NDA	Current
63539-012	XELJANZ	tofacitinib	U.S. Pharmaceuticals	NDA	Current
63539-016	XELJANZ	tofacitinib	U.S. Pharmaceuticals	NDA	Current
63539-016	XELJANZ	tofacitinib	U.S. Pharmaceuticals	NDA	Current
63539-016	XELJANZ	tofacitinib	U.S. Pharmaceuticals	NDA	Current
63539-016	XELJANZ	tofacitinib	U.S. Pharmaceuticals	NDA	Current
63539-016	XELJANZ	tofacitinib	U.S. Pharmaceuticals	NDA	Current
63539-016	XELJANZ	tofacitinib	U.S. Pharmaceuticals	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85347	SUPPL	2026-03-12
85321	SUPPL	2026-03-11
85301	SUPPL	2026-03-09
83839	SUPPL	2025-10-21
83813	SUPPL	2025-10-20
81358	SUPPL	2025-02-25
81331	SUPPL	2025-02-24
79781	SUPPL	2024-09-30
79768	SUPPL	2024-09-30
78509	SUPPL	2024-05-20
78478	SUPPL	2024-05-15
72094	SUPPL	2022-09-16
69588	SUPPL	2021-12-16
69563	SUPPL	2021-12-15
69562	SUPPL	2021-12-15
69479	SUPPL	2021-12-06
69473	SUPPL	2021-12-03
69472	SUPPL	2021-12-03
64753	SUPPL	2020-09-29
64752	SUPPL	2020-09-29
64736	SUPPL	2020-09-29
61275	SUPPL	2019-12-13
61268	SUPPL	2019-12-13
60746	SUPPL	2019-10-31
60745	SUPPL	2019-10-31
59897	SUPPL	2019-09-12
59900	SUPPL	2019-09-03
59899	SUPPL	2019-08-30
59491	SUPPL	2019-07-29
59469	SUPPL	2019-07-26
56071	SUPPL	2018-10-23
56038	SUPPL	2018-10-19
55259	SUPPL	2018-08-21
55216	SUPPL	2018-08-20
54385	SUPPL	2018-05-31
54373	SUPPL	2018-05-30
53726	SUPPL	2018-04-18
50708	SUPPL	2017-12-15
50700	SUPPL	2017-12-15
49528	SUPPL	2017-08-24
49525	SUPPL	2017-08-24
47468	SUPPL	2017-03-06
32395	SUPPL	2016-02-09
10189	SUPPL	2015-12-23
22916	SUPPL	2015-09-25
32394	SUPPL	2015-06-24
40277	SUPPL	2015-06-23
10188	SUPPL	2015-02-17
19448	SUPPL	2014-05-12
10187	SUPPL	2014-05-08
19447	SUPPL	2014-04-01
10186	SUPPL	2014-03-28
19446	SUPPL	2014-02-25
10185	SUPPL	2014-02-25
40276	SUPPL	2013-11-22
10184	SUPPL	2013-11-20
32393	SUPPL	2013-11-12
44880	ORIG	2012-12-18
43425	ORIG	2012-12-18
40275	ORIG	2012-11-28
32392	ORIG	2012-11-07