Application 202324

Type: NDA
Sponsor: PF PRISM CV

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	INLYTA	AXITINIB	TABLET;ORAL	1MG	Yes	No
002	INLYTA	AXITINIB	TABLET;ORAL	5MG	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
N202324-001	INLYTA	AXITINIB	1MG	TABLET / ORAL		RLD	2012-01-27
N202324-002	INLYTA	AXITINIB	5MG	TABLET / ORAL		RLD, RS	2012-01-27

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
N202324-001	8791140	2030-12-14		Drug substance
N202324-001	8791140*PED	2031-06-14		Pediatric extension
N202324-001	10570202	2035-02-03	U-2844		2020-06-30
N202324-001	12534530	2035-02-03	U-4411		2026-02-23
N202324-001	12534530	2035-02-03	U-4412		2026-02-23
N202324-001	10570202*PED	2035-08-03		Pediatric extension
N202324-001	12534530*PED	2035-08-03		Pediatric extension
N202324-001	10869924	2037-01-12	U-3044		2021-01-21
N202324-001	10869924*PED	2037-07-12		Pediatric extension
N202324-002	8791140	2030-12-14		Drug substance
N202324-002	8791140*PED	2031-06-14		Pediatric extension
N202324-002	10570202	2035-02-03	U-2844		2020-06-30
N202324-002	12534530	2035-02-03	U-4411		2026-02-23
N202324-002	12534530	2035-02-03	U-4412		2026-02-23
N202324-002	10570202*PED	2035-08-03		Pediatric extension
N202324-002	12534530*PED	2035-08-03		Pediatric extension
N202324-002	10869924	2037-01-12	U-3044		2021-01-21
N202324-002	10869924*PED	2037-07-12		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 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	N202324-001	INLYTA	1MG	TABLET / ORAL	AB	RLD	2012-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202324-002	INLYTA	5MG	TABLET / ORAL	AB	RLD, RS	2012-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202324-001	INLYTA	1MG	TABLET / ORAL	AB	RLD	2012-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202324-002	INLYTA	5MG	TABLET / ORAL	AB	RLD, RS	2012-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202324-001	INLYTA	1MG	TABLET / ORAL		RLD	2012-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202324-002	INLYTA	5MG	TABLET / ORAL		RLD, RS	2012-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202324-001	INLYTA	1MG	TABLET / ORAL		RLD	2012-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202324-002	INLYTA	5MG	TABLET / ORAL		RLD, RS	2012-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202324-001	INLYTA	1MG	TABLET / ORAL		RLD	2012-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202324-002	INLYTA	5MG	TABLET / ORAL		RLD, RS	2012-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202324-001	INLYTA	1MG	TABLET / ORAL		RLD	2012-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202324-002	INLYTA	5MG	TABLET / ORAL		RLD, RS	2012-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202324-001	INLYTA	1MG	TABLET / ORAL		RLD	2012-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202324-002	INLYTA	5MG	TABLET / ORAL		RLD, RS	2012-01-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202324-001	INLYTA	1MG	TABLET / ORAL		RLD	2012-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202324-002	INLYTA	5MG	TABLET / ORAL		RLD, RS	2012-01-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202324-001	INLYTA	1MG	TABLET / ORAL		RLD	2012-01-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202324-002	INLYTA	5MG	TABLET / ORAL		RLD, RS	2012-01-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202324-001	INLYTA	1MG	TABLET / ORAL		RLD	2012-01-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202324-002	INLYTA	5MG	TABLET / ORAL		RLD, RS	2012-01-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202324-001	INLYTA	1MG	TABLET / ORAL		RLD	2012-01-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202324-002	INLYTA	5MG	TABLET / ORAL		RLD, RS	2012-01-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202324-001	INLYTA	1MG	TABLET / ORAL		RLD	2012-01-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202324-002	INLYTA	5MG	TABLET / ORAL		RLD, RS	2012-01-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202324-001	INLYTA	1MG	TABLET / ORAL		RLD	2012-01-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202324-002	INLYTA	5MG	TABLET / ORAL		RLD, RS	2012-01-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202324-001	INLYTA	1MG	TABLET / ORAL		RLD	2012-01-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202324-002	INLYTA	5MG	TABLET / ORAL		RLD, RS	2012-01-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202324-001	INLYTA	1MG	TABLET / ORAL		RLD	2012-01-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202324-002	INLYTA	5MG	TABLET / ORAL		RLD, RS	2012-01-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202324-001	INLYTA	1MG	TABLET / ORAL		RLD	2012-01-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N202324-002	INLYTA	5MG	TABLET / ORAL		RLD, RS	2012-01-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202324-001	INLYTA	1MG	TABLET / ORAL		RLD	2012-01-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N202324-002	INLYTA	5MG	TABLET / ORAL		RLD, RS	2012-01-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N202324-001	INLYTA	1MG	TABLET / ORAL		RLD	2012-01-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N202324-002	INLYTA	5MG	TABLET / ORAL		RLD, RS	2012-01-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N202324-001	INLYTA	1MG	TABLET / ORAL		RLD	2012-01-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N202324-002	INLYTA	5MG	TABLET / ORAL		RLD, RS	2012-01-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N202324-001	INLYTA	1MG	TABLET / ORAL		RLD	2012-01-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N202324-002	INLYTA	5MG	TABLET / ORAL		RLD, RS	2012-01-27	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N202324-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202324-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202324-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202324-002	AB	1	`31067a03dcf5…`

Observed Orange Book patent history#

Patent history page 1 of 11 · 414 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	N202324-001	8791140	2030-12-14		Drug substance		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202324-001	8791140*PED	2031-06-14		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202324-001	10570202	2035-02-03	U-2844		2020-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202324-001	10570202*PED	2035-08-03		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202324-001	10869924	2037-01-12	U-3044		2021-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202324-001	10869924*PED	2037-07-12		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202324-002	8791140	2030-12-14		Drug substance		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202324-002	8791140*PED	2031-06-14		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202324-002	10570202	2035-02-03	U-2844		2020-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202324-002	10570202*PED	2035-08-03		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202324-002	10869924	2037-01-12	U-3044		2021-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202324-002	10869924*PED	2037-07-12		Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202324-001	6534524	2025-04-29		Drug substance, Drug product	2012-02-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202324-001	6534524*PED	2025-10-29		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202324-001	8791140	2030-12-14		Drug substance		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202324-001	8791140*PED	2031-06-14		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202324-001	10570202	2035-02-03	U-2844		2020-06-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202324-001	10570202*PED	2035-08-03		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202324-001	10869924	2037-01-12	U-3044		2021-01-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202324-001	10869924*PED	2037-07-12		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202324-002	6534524	2025-04-29		Drug substance, Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202324-002	6534524*PED	2025-10-29		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202324-002	8791140	2030-12-14		Drug substance		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202324-002	8791140*PED	2031-06-14		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202324-002	10570202	2035-02-03	U-2844		2020-06-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202324-002	10570202*PED	2035-08-03		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202324-002	10869924	2037-01-12	U-3044		2021-01-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202324-002	10869924*PED	2037-07-12		Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202324-001	6534524	2025-04-29		Drug substance, Drug product	2012-02-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202324-001	6534524*PED	2025-10-29		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202324-001	8791140	2030-12-14		Drug substance		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202324-001	8791140*PED	2031-06-14		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202324-001	10570202	2035-02-03	U-2844		2020-06-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202324-001	10570202*PED	2035-08-03		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202324-001	10869924	2037-01-12	U-3044		2021-01-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202324-001	10869924*PED	2037-07-12		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202324-002	6534524	2025-04-29		Drug substance, Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202324-002	6534524*PED	2025-10-29		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202324-002	8791140	2030-12-14		Drug substance		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202324-002	8791140*PED	2031-06-14		Pediatric extension		`6a471c1ec25d…`

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
INLYTA	AXITINIB	U.S. Pharmaceuticals	8a903e31-936e-4ed7-8a59-59f32374f338	2026-03-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202324 application number: NDA202324 ndc (product): 63539-026 ndc (product): 63539-044
INLYTA	AXITINIB	Pfizer Laboratories Div Pfizer Inc	84137882-e000-47da-bd5b-fa76ab3c76f9	2025-02-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202324 application number: NDA202324 ndc (product): 0069-0151 ndc (product): 0069-0145

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
0069-0145	INLYTA	axitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0145	INLYTA	axitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0145	INLYTA	axitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0145	INLYTA	axitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0145	INLYTA	axitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0145	INLYTA	axitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0151	INLYTA	axitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0151	INLYTA	axitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0151	INLYTA	axitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0151	INLYTA	axitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0151	INLYTA	axitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0151	INLYTA	axitinib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
63539-026	INLYTA	axitinib	U.S. Pharmaceuticals	NDA	Current
63539-026	INLYTA	axitinib	U.S. Pharmaceuticals	NDA	Current
63539-026	INLYTA	axitinib	U.S. Pharmaceuticals	NDA	Current
63539-026	INLYTA	axitinib	U.S. Pharmaceuticals	NDA	Current
63539-044	INLYTA	axitinib	U.S. Pharmaceuticals	NDA	Current
63539-044	INLYTA	axitinib	U.S. Pharmaceuticals	NDA	Current
63539-044	INLYTA	axitinib	U.S. Pharmaceuticals	NDA	Current
63539-044	INLYTA	axitinib	U.S. Pharmaceuticals	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79135	SUPPL	2024-07-22
79107	SUPPL	2024-07-17
72196	SUPPL	2022-09-30
72143	SUPPL	2022-09-23
63431	SUPPL	2020-06-08
63425	SUPPL	2020-06-05
61645	SUPPL	2020-01-24
61637	SUPPL	2020-01-24
55201	SUPPL	2018-08-17
55171	SUPPL	2018-08-13
19319	SUPPL	2015-12-29
32233	SUPPL	2014-12-31
40167	SUPPL	2014-08-04
10025	SUPPL	2014-08-04
10024	SUPPL	2013-09-17
19318	SUPPL	2013-09-16
43395	ORIG	2012-02-27
24416	ORIG	2012-02-27
10023	ORIG	2012-01-31
19317	ORIG	2012-01-27