Application 202714

Type: NDA
Sponsor: ONYX THERAP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KYPROLIS	CARFILZOMIB	POWDER;INTRAVENOUS	60MG/VIAL	Yes	Yes
002	KYPROLIS	CARFILZOMIB	POWDER;INTRAVENOUS	30MG/VIAL	Yes	No
003	KYPROLIS	CARFILZOMIB	POWDER;INTRAVENOUS	10MG/VIAL	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N202714-001	KYPROLIS	CARFILZOMIB	60MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2012-07-20
N202714-002	KYPROLIS	CARFILZOMIB	30MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2016-06-03
N202714-003	KYPROLIS	CARFILZOMIB	10MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2018-06-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N202714-001	AP

Orange Book patents#

Current patent rows page 1 of 1 · 30 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N202714-001	7417042	2026-07-20		Drug substance, Drug product	2012-08-09
N202714-001	7417042*PED	2027-01-20		Pediatric extension
N202714-001	7737112	2027-12-07		Drug product	2012-08-09
N202714-001	7737112*PED	2028-06-07		Pediatric extension
N202714-001	RE47954	2029-10-21	U-3449		2022-10-18
N202714-001	RE47954*PED	2030-04-21		Pediatric extension
N202714-001	9493582	2033-02-27		Drug product	2017-03-09
N202714-001	9493582*PED	2033-08-27		Pediatric extension
N202714-001	12636340	2041-04-29	U-4551		2026-06-23
N202714-001	12636340*PED	2041-10-29		Pediatric extension
N202714-002	7417042	2026-07-20		Drug substance, Drug product	2016-08-15
N202714-002	7417042*PED	2027-01-20		Pediatric extension
N202714-002	7737112	2027-12-07		Drug product	2016-08-15
N202714-002	7737112*PED	2028-06-07		Pediatric extension
N202714-002	RE47954	2029-10-21	U-3449		2022-10-18
N202714-002	RE47954*PED	2030-04-21		Pediatric extension
N202714-002	9493582	2033-02-27		Drug product	2017-03-09
N202714-002	9493582*PED	2033-08-27		Pediatric extension
N202714-002	12636340	2041-04-29	U-4551		2026-06-23
N202714-002	12636340*PED	2041-10-29		Pediatric extension
N202714-003	7417042	2026-07-20		Drug substance, Drug product	2018-06-20
N202714-003	7417042*PED	2027-01-20		Pediatric extension
N202714-003	7737112	2027-12-07		Drug product	2018-06-20
N202714-003	7737112*PED	2028-06-07		Pediatric extension
N202714-003	RE47954	2029-10-21	U-3449		2022-10-18
N202714-003	RE47954*PED	2030-04-21		Pediatric extension
N202714-003	9493582	2033-02-27		Drug product	2018-06-20
N202714-003	9493582*PED	2033-08-27		Pediatric extension
N202714-003	12636340	2041-04-29	U-4551		2026-06-23
N202714-003	12636340*PED	2041-10-29		Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 6 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N202714-001	M-14	2028-05-22
N202714-001	PED	2028-11-22
N202714-002	M-14	2028-05-22
N202714-002	PED	2028-11-22
N202714-003	M-14	2028-05-22
N202714-003	PED	2028-11-22

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 4 · 129 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
2026-09-14 22:38:34	2026-08	N202714-001	KYPROLIS	60MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2012-07-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202714-002	KYPROLIS	30MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2016-06-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202714-003	KYPROLIS	10MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2018-06-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N202714-001	KYPROLIS	60MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2012-07-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202714-002	KYPROLIS	30MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2016-06-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202714-003	KYPROLIS	10MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2018-06-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202714-001	KYPROLIS	60MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2012-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202714-002	KYPROLIS	30MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2016-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202714-003	KYPROLIS	10MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2018-06-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202714-001	KYPROLIS	60MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2012-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202714-002	KYPROLIS	30MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2016-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202714-003	KYPROLIS	10MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2018-06-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202714-001	KYPROLIS	60MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2012-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202714-002	KYPROLIS	30MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2016-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202714-003	KYPROLIS	10MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2018-06-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202714-001	KYPROLIS	60MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2012-07-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202714-002	KYPROLIS	30MG/VIAL	POWDER / INTRAVENOUS		RLD	2016-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202714-003	KYPROLIS	10MG/VIAL	POWDER / INTRAVENOUS		RLD	2018-06-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202714-001	KYPROLIS	60MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2012-07-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202714-002	KYPROLIS	30MG/VIAL	POWDER / INTRAVENOUS		RLD	2016-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202714-003	KYPROLIS	10MG/VIAL	POWDER / INTRAVENOUS		RLD	2018-06-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202714-001	KYPROLIS	60MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2012-07-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202714-002	KYPROLIS	30MG/VIAL	POWDER / INTRAVENOUS		RLD	2016-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202714-003	KYPROLIS	10MG/VIAL	POWDER / INTRAVENOUS		RLD	2018-06-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202714-001	KYPROLIS	60MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2012-07-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202714-002	KYPROLIS	30MG/VIAL	POWDER / INTRAVENOUS		RLD	2016-06-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202714-003	KYPROLIS	10MG/VIAL	POWDER / INTRAVENOUS		RLD	2018-06-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202714-001	KYPROLIS	60MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2012-07-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202714-002	KYPROLIS	30MG/VIAL	POWDER / INTRAVENOUS		RLD	2016-06-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202714-003	KYPROLIS	10MG/VIAL	POWDER / INTRAVENOUS		RLD	2018-06-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202714-001	KYPROLIS	60MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2012-07-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202714-002	KYPROLIS	30MG/VIAL	POWDER / INTRAVENOUS		RLD	2016-06-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202714-003	KYPROLIS	10MG/VIAL	POWDER / INTRAVENOUS		RLD	2018-06-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202714-001	KYPROLIS	60MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2012-07-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202714-002	KYPROLIS	30MG/VIAL	POWDER / INTRAVENOUS		RLD	2016-06-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202714-003	KYPROLIS	10MG/VIAL	POWDER / INTRAVENOUS		RLD	2018-06-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202714-001	KYPROLIS	60MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2012-07-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202714-002	KYPROLIS	30MG/VIAL	POWDER / INTRAVENOUS		RLD	2016-06-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202714-003	KYPROLIS	10MG/VIAL	POWDER / INTRAVENOUS		RLD	2018-06-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202714-001	KYPROLIS	60MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2012-07-20	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N202714-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N202714-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202714-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202714-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202714-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202714-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202714-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202714-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202714-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202714-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202714-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202714-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202714-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202714-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202714-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202714-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202714-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202714-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202714-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N202714-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N202714-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N202714-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202714-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N202714-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N202714-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N202714-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N202714-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N202714-001	AP	1	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N202714-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N202714-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N202714-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N202714-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N202714-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N202714-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N202714-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N202714-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N202714-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N202714-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N202714-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N202714-001	AP	1	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 57 · 2,277 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	N202714-001	7417042	2026-07-20		Drug substance, Drug product	2012-08-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202714-001	7417042*PED	2027-01-20		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202714-001	7737112	2027-12-07		Drug product	2012-08-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202714-001	7737112*PED	2028-06-07		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202714-001	RE47954	2029-10-21	U-3449		2022-10-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202714-001	RE47954*PED	2030-04-21		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202714-001	9493582	2033-02-27		Drug product	2017-03-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202714-001	9493582*PED	2033-08-27		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202714-001	12636340	2041-04-29	U-4551		2026-06-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202714-001	12636340*PED	2041-10-29		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202714-002	7417042	2026-07-20		Drug substance, Drug product	2016-08-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202714-002	7417042*PED	2027-01-20		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202714-002	7737112	2027-12-07		Drug product	2016-08-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202714-002	7737112*PED	2028-06-07		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202714-002	RE47954	2029-10-21	U-3449		2022-10-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202714-002	RE47954*PED	2030-04-21		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202714-002	9493582	2033-02-27		Drug product	2017-03-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202714-002	9493582*PED	2033-08-27		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202714-002	12636340	2041-04-29	U-4551		2026-06-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202714-002	12636340*PED	2041-10-29		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202714-003	7417042	2026-07-20		Drug substance, Drug product	2018-06-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202714-003	7417042*PED	2027-01-20		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202714-003	7737112	2027-12-07		Drug product	2018-06-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202714-003	7737112*PED	2028-06-07		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202714-003	RE47954	2029-10-21	U-3449		2022-10-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202714-003	RE47954*PED	2030-04-21		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202714-003	9493582	2033-02-27		Drug product	2018-06-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202714-003	9493582*PED	2033-08-27		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202714-003	12636340	2041-04-29	U-4551		2026-06-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202714-003	12636340*PED	2041-10-29		Pediatric extension		`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N202714-001	7417042	2026-07-20		Drug substance, Drug product	2012-08-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202714-001	7417042*PED	2027-01-20		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202714-001	7737112	2027-12-07		Drug product	2012-08-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202714-001	7737112*PED	2028-06-07		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202714-001	RE47954	2029-10-21	U-3449		2022-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202714-001	RE47954*PED	2030-04-21		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202714-001	9493582	2033-02-27		Drug product	2017-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202714-001	9493582*PED	2033-08-27		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202714-001	12636340	2041-04-29	U-4551		2026-06-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202714-001	12636340*PED	2041-10-29		Pediatric extension		`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 147 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N202714-001	M-14	2028-05-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202714-001	PED	2028-11-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202714-002	M-14	2028-05-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202714-002	PED	2028-11-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202714-003	M-14	2028-05-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202714-003	PED	2028-11-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N202714-001	M-14	2028-05-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202714-001	PED	2028-11-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202714-002	M-14	2028-05-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202714-002	PED	2028-11-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202714-003	M-14	2028-05-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202714-003	PED	2028-11-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202714-001	M-14	2028-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202714-001	PED	2028-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202714-002	M-14	2028-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202714-002	PED	2028-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202714-003	M-14	2028-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202714-003	PED	2028-11-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202714-001	M-14	2028-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202714-001	PED	2028-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202714-002	M-14	2028-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202714-002	PED	2028-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202714-003	M-14	2028-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202714-003	PED	2028-11-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202714-001	M-14	2028-05-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202714-001	PED	2028-11-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202714-002	M-14	2028-05-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202714-002	PED	2028-11-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202714-003	M-14	2028-05-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202714-003	PED	2028-11-22	`6a471c1ec25d…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202714-001	I-842	2023-08-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202714-002	I-842	2023-08-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202714-003	I-842	2023-08-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202714-001	I-842	2023-08-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N202714-002	I-842	2023-08-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N202714-003	I-842	2023-08-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202714-001	I-842	2023-08-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N202714-002	I-842	2023-08-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N202714-003	I-842	2023-08-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N202714-001	I-722	2019-01-21	`74a2ff9319b5…`

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
KYPROLIS	CARFILZOMIB	Onyx Pharmaceuticals, Inc.	ea66eb30-e665-4693-99a1-a9d3b4bbe2d6	2025-06-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202714 application number: NDA202714 ndc (product): 76075-103 ndc (product): 76075-101 ndc (product): 76075-102

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 33 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
76075-101	KYPROLIS	carfilzomib	Onyx Pharmaceuticals, Inc.	NDA	Current
76075-101	KYPROLIS	carfilzomib	Onyx Pharmaceuticals, Inc.	NDA	Current
76075-101	KYPROLIS	carfilzomib	Onyx Pharmaceuticals, Inc.	NDA	Current
76075-101	KYPROLIS	carfilzomib	Onyx Pharmaceuticals, Inc.	NDA	Current
76075-101	KYPROLIS	carfilzomib	Onyx Pharmaceuticals, Inc.	NDA	Current
76075-101	KYPROLIS	carfilzomib	Onyx Pharmaceuticals, Inc.	NDA	Current
76075-101	KYPROLIS	carfilzomib	Onyx Pharmaceuticals, Inc.	NDA	Current
76075-101	KYPROLIS	carfilzomib	Onyx Pharmaceuticals, Inc.	NDA	Current
76075-101	KYPROLIS	carfilzomib	Onyx Pharmaceuticals, Inc.	NDA	Current
76075-101	KYPROLIS	carfilzomib	Onyx Pharmaceuticals, Inc.	NDA	Current
76075-101	KYPROLIS	carfilzomib	Onyx Pharmaceuticals, Inc.	NDA	Current
76075-102	KYPROLIS	carfilzomib	Onyx Pharmaceuticals, Inc.	NDA	Current
76075-102	KYPROLIS	carfilzomib	Onyx Pharmaceuticals, Inc.	NDA	Current
76075-102	KYPROLIS	carfilzomib	Onyx Pharmaceuticals, Inc.	NDA	Current
76075-102	KYPROLIS	carfilzomib	Onyx Pharmaceuticals, Inc.	NDA	Current
76075-102	KYPROLIS	carfilzomib	Onyx Pharmaceuticals, Inc.	NDA	Current
76075-102	KYPROLIS	carfilzomib	Onyx Pharmaceuticals, Inc.	NDA	Current
76075-102	KYPROLIS	carfilzomib	Onyx Pharmaceuticals, Inc.	NDA	Current
76075-102	KYPROLIS	carfilzomib	Onyx Pharmaceuticals, Inc.	NDA	Current
76075-102	KYPROLIS	carfilzomib	Onyx Pharmaceuticals, Inc.	NDA	Current
76075-102	KYPROLIS	carfilzomib	Onyx Pharmaceuticals, Inc.	NDA	Current
76075-102	KYPROLIS	carfilzomib	Onyx Pharmaceuticals, Inc.	NDA	Current
76075-103	KYPROLIS	carfilzomib	Onyx Pharmaceuticals, Inc.	NDA	Current
76075-103	KYPROLIS	carfilzomib	Onyx Pharmaceuticals, Inc.	NDA	Current
76075-103	KYPROLIS	carfilzomib	Onyx Pharmaceuticals, Inc.	NDA	Current
76075-103	KYPROLIS	carfilzomib	Onyx Pharmaceuticals, Inc.	NDA	Current
76075-103	KYPROLIS	carfilzomib	Onyx Pharmaceuticals, Inc.	NDA	Current
76075-103	KYPROLIS	carfilzomib	Onyx Pharmaceuticals, Inc.	NDA	Current
76075-103	KYPROLIS	carfilzomib	Onyx Pharmaceuticals, Inc.	NDA	Current
76075-103	KYPROLIS	carfilzomib	Onyx Pharmaceuticals, Inc.	NDA	Current
76075-103	KYPROLIS	carfilzomib	Onyx Pharmaceuticals, Inc.	NDA	Current
76075-103	KYPROLIS	carfilzomib	Onyx Pharmaceuticals, Inc.	NDA	Current
76075-103	KYPROLIS	carfilzomib	Onyx Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82410	SUPPL	2025-06-02
82314	SUPPL	2025-05-27
71506	SUPPL	2022-07-05
71505	SUPPL	2022-07-01
69434	SUPPL	2021-12-01
69430	SUPPL	2021-12-01
66741	SUPPL	2021-03-11
66709	SUPPL	2021-03-10
64379	SUPPL	2020-08-24
64333	SUPPL	2020-08-20
62882	SUPPL	2020-05-11
62879	SUPPL	2020-05-08
60453	SUPPL	2019-10-09
60254	SUPPL	2019-10-07
57872	SUPPL	2019-03-01
57863	SUPPL	2019-03-01
57349	SUPPL	2019-01-28
55793	SUPPL	2018-10-03
55770	SUPPL	2018-10-01
54558	SUPPL	2018-06-14
54493	SUPPL	2018-06-11
51091	SUPPL	2018-01-18
51076	SUPPL	2018-01-17
48563	SUPPL	2017-05-30
48559	SUPPL	2017-05-30
45986	SUPPL	2016-12-01
45908	SUPPL	2016-11-18
44998	SUPPL	2016-08-04
44986	SUPPL	2016-08-04
19370	SUPPL	2016-07-06
10097	SUPPL	2016-07-06
40209	SUPPL	2016-05-25
10096	SUPPL	2016-05-25
40208	SUPPL	2016-01-26
32291	SUPPL	2016-01-22
32290	SUPPL	2015-07-27
40207	SUPPL	2015-07-24
19369	SUPPL	2015-04-07
32289	SUPPL	2015-04-03
44863	ORIG	2012-08-20
43410	ORIG	2012-08-20
32288	ORIG	2012-07-20
19368	ORIG	2012-07-20