Application 213082

Type: NDA
Sponsor: PFIZER INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	XELJANZ	TOFACITINIB	SOLUTION; ORAL	5MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N213082-001	XELJANZ	TOFACITINIB CITRATE	EQ 1MG BASE/ML	SOLUTION / ORAL	AA	RLD, RS	2020-09-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N213082-001	AA

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N213082-001	RE41783	2025-12-08		Drug substance	2020-10-22
N213082-001	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
N213082-001	M-14	2028-02-21
N213082-001	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.

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
2026-10-15 13:18:30	2026-09	N213082-001	XELJANZ	EQ 1MG BASE/ML	SOLUTION / ORAL	AA	RLD, RS	2020-09-25	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N213082-001	XELJANZ	EQ 1MG BASE/ML	SOLUTION / ORAL	AA	RLD, RS	2020-09-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N213082-001	XELJANZ	EQ 1MG BASE/ML	SOLUTION / ORAL	AA	RLD, RS	2020-09-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213082-001	XELJANZ	EQ 1MG BASE/ML	SOLUTION / ORAL		RLD, RS	2020-09-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213082-001	XELJANZ	EQ 1MG BASE/ML	SOLUTION / ORAL		RLD, RS	2020-09-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213082-001	XELJANZ	EQ 1MG BASE/ML	SOLUTION / ORAL		RLD, RS	2020-09-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213082-001	XELJANZ	EQ 1MG BASE/ML	SOLUTION / ORAL		RLD, RS	2020-09-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213082-001	XELJANZ	EQ 1MG BASE/ML	SOLUTION / ORAL		RLD, RS	2020-09-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213082-001	XELJANZ	EQ 1MG BASE/ML	SOLUTION / ORAL		RLD, RS	2020-09-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213082-001	XELJANZ	EQ 1MG BASE/ML	SOLUTION / ORAL		RLD, RS	2020-09-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213082-001	XELJANZ	EQ 1MG BASE/ML	SOLUTION / ORAL	AA	RLD, RS	2020-09-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213082-001	XELJANZ	EQ 1MG BASE/ML	SOLUTION / ORAL		RLD, RS	2020-09-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213082-001	XELJANZ	EQ 1MG BASE/ML	SOLUTION / ORAL	AA	RLD, RS	2020-09-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213082-001	XELJANZ	EQ 1MG BASE/ML	SOLUTION / ORAL	AA	RLD, RS	2020-09-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213082-001	XELJANZ	EQ 1MG BASE/ML	SOLUTION / ORAL	AA	RLD, RS	2020-09-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213082-001	XELJANZ	EQ 1MG BASE/ML	SOLUTION / ORAL	AA	RLD, RS	2020-09-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213082-001	XELJANZ	EQ 1MG BASE/ML	SOLUTION / ORAL	AA	RLD, RS	2020-09-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213082-001	XELJANZ	EQ 1MG/ML BASE	SOLUTION / ORAL		RLD, RS	2020-09-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213082-001	XELJANZ	EQ 1MG/ML BASE	SOLUTION / ORAL		RLD, RS	2020-09-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213082-001	XELJANZ	EQ 1MG/ML BASE	SOLUTION / ORAL		RLD, RS	2020-09-25	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213082-001	XELJANZ	EQ 1MG/ML BASE	SOLUTION / ORAL		RLD, RS	2020-09-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N213082-001	XELJANZ	EQ 1MG/ML BASE	SOLUTION / ORAL		RLD, RS	2020-09-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N213082-001	XELJANZ	EQ 1MG/ML BASE	SOLUTION / ORAL		RLD, RS	2020-09-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N213082-001	Xeljanz	EQ 1MG/ML BASE	SOLUTION / ORAL		RLD, RS	2020-09-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N213082-001	Xeljanz	EQ 1MG/ML BASE	SOLUTION / ORAL		RLD, RS	2020-09-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N213082-001	Xeljanz	EQ 1MG/ML BASE	SOLUTION / ORAL		RLD, RS	2020-09-25	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213082-001	XELJANZ	EQ 1MG BASE/ML	SOLUTION / ORAL	AA	RLD, RS	2020-09-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N213082-001	XELJANZ	EQ 1MG BASE/ML	SOLUTION / ORAL	AA	RLD, RS	2020-09-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N213082-001	XELJANZ	EQ 1MG BASE/ML	SOLUTION / ORAL	AA	RLD, RS	2020-09-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213082-001	XELJANZ	EQ 1MG BASE/ML	SOLUTION / ORAL	AA	RLD, RS	2020-09-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213082-001	XELJANZ	EQ 1MG BASE/ML	SOLUTION / ORAL	AA	RLD, RS	2020-09-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213082-001	XELJANZ	EQ 1MG/ML BASE	SOLUTION / ORAL		RLD, RS	2020-09-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213082-001	XELJANZ	EQ 1MG/ML BASE	SOLUTION / ORAL		RLD, RS	2020-09-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N213082-001	XELJANZ	EQ 1MG/ML BASE	SOLUTION / ORAL		RLD, RS	2020-09-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N213082-001	XELJANZ	EQ 1MG/ML BASE	SOLUTION / ORAL		RLD, RS	2020-09-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213082-001	XELJANZ	EQ 1MG/ML BASE	SOLUTION / ORAL		RLD, RS	2020-09-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N213082-001	XELJANZ	EQ 1MG/ML BASE	SOLUTION / ORAL		RLD, RS	2020-09-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N213082-001	XELJANZ	EQ 1MG/ML BASE	SOLUTION / ORAL		RLD, RS	2020-09-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N213082-001	XELJANZ	EQ 1MG/ML BASE	SOLUTION / ORAL		RLD, RS	2020-09-25	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213082-001	XELJANZ	EQ 1MG BASE/ML	SOLUTION / ORAL	AA	RLD, RS	2020-09-25	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N213082-001	AA	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N213082-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N213082-001	AA	1	`caaa826d4ba7…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213082-001	AA	1	`5bbf6a4d5a75…`
2024-10-29 15:01 UTC	2024-10	N213082-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213082-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213082-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213082-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213082-001	AA	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213082-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N213082-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N213082-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213082-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213082-001	AA	1	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213082-001	AA	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N213082-001	RE41783*PED	2026-06-08	Pediatric extension		`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213082-001	RE41783*PED	2026-06-08	Pediatric extension		`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213082-001	RE41783*PED	2026-06-08	Pediatric extension		`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213082-001	RE41783*PED	2026-06-08	Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213082-001	RE41783*PED	2026-06-08	Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213082-001	RE41783*PED	2026-06-08	Pediatric extension		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213082-001	RE41783*PED	2026-06-08	Pediatric extension		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N213082-001	6956041	2020-12-08	Drug product	2020-10-22	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N213082-001	7265221	2020-12-08	Drug substance	2020-10-22	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N213082-001	7301023	2020-12-08	Drug substance	2020-10-22	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N213082-001	6956041	2020-12-08	Drug product	2020-10-22	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N213082-001	7265221	2020-12-08	Drug substance	2020-10-22	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N213082-001	7301023	2020-12-08	Drug substance	2020-10-22	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213082-001	RE41783	2025-12-08	Drug substance	2020-10-22	`6a51e52b5d6a…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-10-15 13:18:30	2026-09	N213082-001	M-14	2028-02-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N213082-001	PED	2028-08-21	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N213082-001	M-14	2028-02-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213082-001	PED	2028-08-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N213082-001	M-14	2028-02-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213082-001	PED	2028-08-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213082-001	M-14	2028-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213082-001	PED	2028-08-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213082-001	M-14	2028-02-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213082-001	PED	2028-08-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213082-001	M-14	2028-02-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213082-001	PED	2028-08-21	`6a471c1ec25d…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213082-001	NP	2023-09-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213082-001	NP	2023-09-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213082-001	NP	2023-09-25	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213082-001	NP	2023-09-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N213082-001	NP	2023-09-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N213082-001	NP	2023-09-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N213082-001	NP	2023-09-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N213082-001	NP	2023-09-25	`8869cabd3fbd…`
2023-12-20 04:57 UTC	2023-12	N213082-001	NP	2023-09-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213082-001	NP	2023-09-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213082-001	NP	2023-09-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213082-001	NP	2023-09-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213082-001	NP	2023-09-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N213082-001	NP	2023-09-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N213082-001	NP	2023-09-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213082-001	NP	2023-09-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N213082-001	NP	2023-09-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N213082-001	NP	2023-09-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N213082-001	NP	2023-09-25	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213082-001	M-14	2028-02-21	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213082-001	PED	2028-08-21	`a50c72e98297…`

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 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tofacitinib	TOFACITINIB	Novadoz Pharmaceuticals LLC	253635c8-1ea7-41ba-b216-dea5e3305c47	2026-09-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TOFACITINIB
TOFACITINIB	TOFACITINIB	Novadoz Pharmaceuticals LLC	327f6b60-1a5d-49e6-acff-18603d0ee9d0	2026-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TOFACITINIB
Tofacitinib	TOFACITINIB	Edenbridge Pharmaceuticals LLC.	576722e5-6639-452d-a5c3-33a064f19481	2026-08-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TOFACITINIB
Tofacitinib	TOFACITINIB	Golden State Medical Supply, Inc.	58f22c41-87d2-e745-e063-6394a90a962e	2026-08-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TOFACITINIB
tofacitinib	TOFACITINIB	Zydus Pharmaceuticals USA Inc.	179ffbb2-bedc-40e6-b77b-33d4f7832172	2026-08-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TOFACITINIB
Tofacitinib	TOFACITINIB	Macleods Pharmaceuticals Limited	9b654f0d-7705-4880-9e9d-ad3a51e56b56	2026-08-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TOFACITINIB
Tofacitinib	TOFACITINIB	Apotex Corp.	7d4f5cfa-35a8-1458-a609-f6b417946abb	2026-08-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TOFACITINIB
Tofacitinib	TOFACITINIB	AvKARE	5751321a-c904-44ae-e063-6394a90a2654	2026-07-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TOFACITINIB
TOFACITINIB	TOFACITINIB	Aurobindo Pharma Limited	e54b186f-e42a-4477-939c-8dd331045fbe	2026-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TOFACITINIB
TOFACITINIB	TOFACITINIB	Aurobindo Pharma Limited	50962b08-99dd-ae73-e063-6394a90ad1eb	2026-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TOFACITINIB
TOFACITINIB	TOFACITINIB	IPG Pharmaceuticals, Inc	cd1b61bf-de03-4198-89f6-f3952b79d2c2	2026-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TOFACITINIB
tofacitinib solution	TOFACITINIB	Hikma Pharmaceuticals USA Inc.	d9cf18a9-e825-49ac-b080-68957c0e79ae	2026-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TOFACITINIB
TOFACITINIB	TOFACITINIB	Orient Pharma Co., Ltd. Yunlin Plant	5617a652-a78e-74b1-e063-6394a90a31c7	2026-06-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TOFACITINIB
Tofacitinib	TOFACITINIB	AvKARE	5502f252-2b39-2cfd-e063-6394a90a8a48	2026-06-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TOFACITINIB
Tofacitinib	TOFACITINIB	Ajanta Pharma USA Inc.	024bb9f2-8c26-4d9d-a33b-eb3c0a7c59ed	2026-06-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TOFACITINIB
TOFACITINIB	TOFACITINIB	Somerset Therapeutics, LLC	2726c2b0-c763-4635-ac6b-4334c3a5a8bc	2026-06-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TOFACITINIB
tofacitinib	TOFACITINIB	Zydus Lifesciences Limited	f4d0e580-74a8-496e-89a2-d74478c946bf	2026-05-29		Name fallback generic name: TOFACITINIB
tofacitinib	TOFACITINIB	Zydus Lifesciences Limited	ac0b26d5-1352-42ff-b5ea-3eb02d8508a4	2026-05-12		Name fallback generic name: TOFACITINIB
TOFACITINIB	TOFACITINIB	Exelan pharmaceuticals,Inc	e68680e5-0328-4e66-b8bb-4af126221ec7	2026-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TOFACITINIB

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 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0069-1029	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1029	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1029	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1029	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1029	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1029	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1029	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1029	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1029	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85323	SUPPL	2026-03-11
85303	SUPPL	2026-03-09
85349	SUPPL	2026-03-06
83841	SUPPL	2025-10-21
83814	SUPPL	2025-10-20
81360	SUPPL	2025-02-25
81335	SUPPL	2025-02-24
79784	SUPPL	2024-09-30
79783	SUPPL	2024-09-30
79772	SUPPL	2024-09-30
78511	SUPPL	2024-05-20
78482	SUPPL	2024-05-15
69590	SUPPL	2021-12-16
69567	SUPPL	2021-12-15
69566	SUPPL	2021-12-15
69482	SUPPL	2021-12-06
69471	SUPPL	2021-12-03
69470	SUPPL	2021-12-03
65049	ORIG	2020-10-29
64742	ORIG	2020-09-29
64741	ORIG	2020-09-29
64740	ORIG	2020-09-29