Application 208246

Type: NDA
Sponsor: PFIZER INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	XELJANZ XR	TOFACITINIB CITRATE	TABLET, EXTENDED RELEASE;ORAL	EQ 11MG BASE	Yes	Yes
002	XELJANZ XR	TOFACITINIB CITRATE	TABLET, EXTENDED RELEASE;ORAL	EQ 22MG BASE	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N208246-001	XELJANZ XR	TOFACITINIB CITRATE	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2016-02-23
N208246-002	XELJANZ XR	TOFACITINIB CITRATE	EQ 22MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2019-12-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N208246-001	AB
N208246-002	AB

Orange Book patents#

Current patent rows page 1 of 1 · 18 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208246-001	RE41783	2025-12-08		Drug substance	2016-03-18
N208246-001	RE41783*PED	2026-06-08		Pediatric extension
N208246-001	11253523	2034-03-14	U-3326		2022-03-23
N208246-001	11253523	2034-03-14	U-3327		2022-03-23
N208246-001	11253523	2034-03-14	U-3328		2022-03-23
N208246-001	11253523	2034-03-14	U-3329		2022-03-23
N208246-001	9937181	2034-03-14		Drug product	2018-05-09
N208246-001	11253523*PED	2034-09-14		Pediatric extension
N208246-001	9937181*PED	2034-09-14		Pediatric extension
N208246-002	RE41783	2025-12-08		Drug substance	2020-01-09
N208246-002	RE41783*PED	2026-06-08		Pediatric extension
N208246-002	10639309	2034-03-14		Drug product	2020-06-03
N208246-002	11253523	2034-03-14	U-3326		2022-03-23
N208246-002	11253523	2034-03-14	U-3327		2022-03-23
N208246-002	11253523	2034-03-14	U-3328		2022-03-23
N208246-002	11253523	2034-03-14	U-3329		2022-03-23
N208246-002	10639309*PED	2034-09-14		Pediatric extension
N208246-002	11253523*PED	2034-09-14		Pediatric extension

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 3 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
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208246-001	XELJANZ XR	EQ 11MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2016-02-23	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208246-002	XELJANZ XR	EQ 22MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2019-12-12	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N208246-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208246-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208246-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208246-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208246-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208246-001	AB	1	`31067a03dcf5…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208246-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208246-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208246-001	AB	1	`03ed91905a0d…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208246-001	AB	1	`1e350fbaab3a…`
2021-12-28 21:50 UTC	2021-12	N208246-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N208246-002	AB	1	`782e0a99824c…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208246-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208246-002	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 14 · 540 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N208246-001	RE41783	2025-12-08		Drug substance	2016-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208246-001	RE41783*PED	2026-06-08		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208246-001	11253523	2034-03-14	U-3326		2022-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208246-001	11253523	2034-03-14	U-3327		2022-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208246-001	11253523	2034-03-14	U-3328		2022-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208246-001	11253523	2034-03-14	U-3329		2022-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208246-001	9937181	2034-03-14		Drug product	2018-05-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208246-001	11253523*PED	2034-09-14		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208246-001	9937181*PED	2034-09-14		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208246-002	RE41783	2025-12-08		Drug substance	2020-01-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208246-002	RE41783*PED	2026-06-08		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208246-002	10639309	2034-03-14		Drug product	2020-06-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208246-002	11253523	2034-03-14	U-3326		2022-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208246-002	11253523	2034-03-14	U-3327		2022-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208246-002	11253523	2034-03-14	U-3328		2022-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208246-002	11253523	2034-03-14	U-3329		2022-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208246-002	10639309*PED	2034-09-14		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208246-002	11253523*PED	2034-09-14		Pediatric extension		`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208246-001	RE41783	2025-12-08		Drug substance	2016-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208246-001	RE41783*PED	2026-06-08		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208246-001	11253523	2034-03-14	U-3326		2022-03-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208246-001	11253523	2034-03-14	U-3327		2022-03-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208246-001	11253523	2034-03-14	U-3328		2022-03-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208246-001	11253523	2034-03-14	U-3329		2022-03-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208246-001	9937181	2034-03-14		Drug product	2018-05-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208246-001	11253523*PED	2034-09-14		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208246-001	9937181*PED	2034-09-14		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208246-002	RE41783	2025-12-08		Drug substance	2020-01-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208246-002	RE41783*PED	2026-06-08		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208246-002	10639309	2034-03-14		Drug product	2020-06-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208246-002	11253523	2034-03-14	U-3326		2022-03-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208246-002	11253523	2034-03-14	U-3327		2022-03-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208246-002	11253523	2034-03-14	U-3328		2022-03-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208246-002	11253523	2034-03-14	U-3329		2022-03-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208246-002	10639309*PED	2034-09-14		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208246-002	11253523*PED	2034-09-14		Pediatric extension		`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208246-001	RE41783	2025-12-08		Drug substance	2016-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208246-001	RE41783*PED	2026-06-08		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208246-001	11253523	2034-03-14	U-3326		2022-03-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208246-001	11253523	2034-03-14	U-3327		2022-03-23	`011fe1cb6892…`

Observed Orange Book exclusivity history#

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	N208246-001	I-879	2024-12-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208246-001	I-879	2024-12-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208246-001	I-879	2024-12-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208246-001	I-879	2024-12-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208246-001	I-879	2024-12-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208246-001	I-879	2024-12-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208246-001	I-879	2024-12-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208246-001	I-879	2024-12-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208246-001	I-879	2024-12-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208246-001	I-879	2024-12-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208246-001	I-879	2024-12-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208246-001	I-879	2024-12-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208246-001	I-761	2020-12-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208246-001	I-879	2024-12-14	`bb7c543d1eb4…`
2020-12-22 03:56 UTC	2020-12	N208246-001	I-761	2020-12-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208246-001	I-761	2020-12-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208246-001	I-761	2020-12-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208246-001	I-761	2020-12-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208246-001	I-761	2020-12-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208246-001	I-879	2024-12-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208246-001	I-879	2024-12-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208246-001	I-879	2024-12-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208246-001	I-879	2024-12-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208246-001	I-879	2024-12-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208246-001	I-879	2024-12-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208246-001	I-879	2024-12-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208246-001	I-879	2024-12-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208246-001	I-879	2024-12-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208246-001	I-879	2024-12-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208246-001	I-879	2024-12-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208246-001	I-879	2024-12-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208246-001	I-879	2024-12-14	`cb3db0bc1861…`

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
XELJANZ	TOFACITINIB	U.S. Pharmaceuticals	68e3d6b2-7838-4d2d-a417-09d919b43e13	2026-07-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 208246 application number: NDA208246 ndc (product): 63539-502 ndc (product): 63539-501

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 · 37 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0069-0501	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0501	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0501	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0501	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0501	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0501	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0501	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0501	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0501	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0501	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0501	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0501	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0501	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0501	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0501	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0502	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0502	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0502	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0502	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0502	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0502	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0502	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0502	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0502	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0502	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0502	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0502	XELJANZ	tofacitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
63539-501	XELJANZ	tofacitinib	U.S. Pharmaceuticals	NDA	Current
63539-501	XELJANZ	tofacitinib	U.S. Pharmaceuticals	NDA	Current
63539-501	XELJANZ	tofacitinib	U.S. Pharmaceuticals	NDA	Current
63539-501	XELJANZ	tofacitinib	U.S. Pharmaceuticals	NDA	Current
63539-501	XELJANZ	tofacitinib	U.S. Pharmaceuticals	NDA	Current
63539-501	XELJANZ	tofacitinib	U.S. Pharmaceuticals	NDA	Current
63539-502	XELJANZ	tofacitinib	U.S. Pharmaceuticals	NDA	Current
63539-502	XELJANZ	tofacitinib	U.S. Pharmaceuticals	NDA	Current
63539-502	XELJANZ	tofacitinib	U.S. Pharmaceuticals	NDA	Current
63539-502	XELJANZ	tofacitinib	U.S. Pharmaceuticals	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85322	SUPPL	2026-03-11
85302	SUPPL	2026-03-09
85348	SUPPL	2026-03-06
81359	SUPPL	2025-02-25
81333	SUPPL	2025-02-24
79782	SUPPL	2024-09-30
79770	SUPPL	2024-09-27
78510	SUPPL	2024-05-20
78480	SUPPL	2024-05-15
69589	SUPPL	2021-12-16
69565	SUPPL	2021-12-15
69564	SUPPL	2021-12-15
69481	SUPPL	2021-12-06
69469	SUPPL	2021-12-03
69468	SUPPL	2021-12-03
61271	SUPPL	2019-12-13
61270	SUPPL	2019-12-13
61265	SUPPL	2019-12-13
59898	SUPPL	2019-09-12
59902	SUPPL	2019-08-30
59493	SUPPL	2019-07-29
59470	SUPPL	2019-07-26
56072	SUPPL	2018-10-23
56039	SUPPL	2018-10-19
55260	SUPPL	2018-08-21
55217	SUPPL	2018-08-20
50709	SUPPL	2017-12-15
50701	SUPPL	2017-12-15
49532	SUPPL	2017-08-24
49529	SUPPL	2017-08-24
48822	ORIG	2017-06-26
40628	ORIG	2016-02-26
32900	ORIG	2016-02-25