Application 208462

Type: NDA
Sponsor: MILLENNIUM PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NINLARO	IXAZOMIB CITRATE	CAPSULE;ORAL	EQ 2.3MG BASE	Yes	No
002	NINLARO	IXAZOMIB CITRATE	CAPSULE;ORAL	EQ 3MG BASE	Yes	No
003	NINLARO	IXAZOMIB CITRATE	CAPSULE;ORAL	EQ 4MG 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N208462-001	NINLARO	IXAZOMIB CITRATE	EQ 2.3MG BASE	CAPSULE / ORAL	RLD	2015-11-20
N208462-002	NINLARO	IXAZOMIB CITRATE	EQ 3MG BASE	CAPSULE / ORAL	RLD	2015-11-20
N208462-003	NINLARO	IXAZOMIB CITRATE	EQ 4MG BASE	CAPSULE / ORAL	RLD, RS	2015-11-20

Orange Book patents#

Current patent rows page 1 of 1 · 21 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208462-001	7687662	2027-08-06		Drug substance, Drug product	2015-12-14
N208462-001	8003819	2027-08-06	U-2434	Drug substance, Drug product	2015-12-14
N208462-001	8530694	2027-08-06	U-2434	Drug substance, Drug product	2015-12-14
N208462-001	8871745	2027-08-06	U-2434		2015-12-14
N208462-001	8859504	2029-06-16		Drug substance, Drug product	2015-12-14
N208462-001	9175017	2029-06-16	U-2434		2015-12-14
N208462-001	7442830	2029-11-20	U-2434	Drug substance, Drug product	2015-12-14
N208462-002	7687662	2027-08-06		Drug substance, Drug product	2015-12-14
N208462-002	8003819	2027-08-06	U-2434	Drug substance, Drug product	2015-12-14
N208462-002	8530694	2027-08-06	U-2434	Drug substance, Drug product	2015-12-14
N208462-002	8871745	2027-08-06	U-2434		2015-12-14
N208462-002	8859504	2029-06-16		Drug substance, Drug product	2015-12-14
N208462-002	9175017	2029-06-16	U-2434		2015-12-14
N208462-002	7442830	2029-11-20	U-2434	Drug substance, Drug product	2015-12-14
N208462-003	7687662	2027-08-06		Drug substance, Drug product	2015-12-14
N208462-003	8003819	2027-08-06	U-2434	Drug substance, Drug product	2015-12-14
N208462-003	8530694	2027-08-06	U-2434	Drug substance, Drug product	2015-12-14
N208462-003	8871745	2027-08-06	U-2434		2015-12-14
N208462-003	8859504	2029-06-16		Drug substance, Drug product	2015-12-14
N208462-003	9175017	2029-06-16	U-2434		2015-12-14
N208462-003	7442830	2029-11-20	U-2434	Drug substance, Drug product	2015-12-14

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 · 123 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	N208462-001	NINLARO	EQ 2.3MG BASE	CAPSULE / ORAL	RLD	2015-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208462-002	NINLARO	EQ 3MG BASE	CAPSULE / ORAL	RLD	2015-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208462-003	NINLARO	EQ 4MG BASE	CAPSULE / ORAL	RLD, RS	2015-11-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208462-001	NINLARO	EQ 2.3MG BASE	CAPSULE / ORAL	RLD	2015-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208462-002	NINLARO	EQ 3MG BASE	CAPSULE / ORAL	RLD	2015-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208462-003	NINLARO	EQ 4MG BASE	CAPSULE / ORAL	RLD, RS	2015-11-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208462-001	NINLARO	EQ 2.3MG BASE	CAPSULE / ORAL	RLD	2015-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208462-002	NINLARO	EQ 3MG BASE	CAPSULE / ORAL	RLD	2015-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208462-003	NINLARO	EQ 4MG BASE	CAPSULE / ORAL	RLD, RS	2015-11-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208462-001	NINLARO	EQ 2.3MG BASE	CAPSULE / ORAL	RLD	2015-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208462-002	NINLARO	EQ 3MG BASE	CAPSULE / ORAL	RLD	2015-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208462-003	NINLARO	EQ 4MG BASE	CAPSULE / ORAL	RLD, RS	2015-11-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208462-001	NINLARO	EQ 2.3MG BASE	CAPSULE / ORAL	RLD	2015-11-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208462-002	NINLARO	EQ 3MG BASE	CAPSULE / ORAL	RLD	2015-11-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208462-003	NINLARO	EQ 4MG BASE	CAPSULE / ORAL	RLD, RS	2015-11-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208462-001	NINLARO	EQ 2.3MG BASE	CAPSULE / ORAL	RLD	2015-11-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208462-002	NINLARO	EQ 3MG BASE	CAPSULE / ORAL	RLD	2015-11-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208462-003	NINLARO	EQ 4MG BASE	CAPSULE / ORAL	RLD, RS	2015-11-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208462-001	NINLARO	EQ 2.3MG BASE	CAPSULE / ORAL	RLD	2015-11-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208462-002	NINLARO	EQ 3MG BASE	CAPSULE / ORAL	RLD	2015-11-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208462-003	NINLARO	EQ 4MG BASE	CAPSULE / ORAL	RLD, RS	2015-11-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208462-001	NINLARO	EQ 2.3MG BASE	CAPSULE / ORAL	RLD	2015-11-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208462-002	NINLARO	EQ 3MG BASE	CAPSULE / ORAL	RLD	2015-11-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208462-003	NINLARO	EQ 4MG BASE	CAPSULE / ORAL	RLD, RS	2015-11-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208462-001	NINLARO	EQ 2.3MG BASE	CAPSULE / ORAL	RLD	2015-11-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208462-002	NINLARO	EQ 3MG BASE	CAPSULE / ORAL	RLD	2015-11-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208462-003	NINLARO	EQ 4MG BASE	CAPSULE / ORAL	RLD, RS	2015-11-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208462-001	NINLARO	EQ 2.3MG BASE	CAPSULE / ORAL	RLD	2015-11-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208462-002	NINLARO	EQ 3MG BASE	CAPSULE / ORAL	RLD	2015-11-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208462-003	NINLARO	EQ 4MG BASE	CAPSULE / ORAL	RLD, RS	2015-11-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208462-001	NINLARO	EQ 2.3MG BASE	CAPSULE / ORAL	RLD	2015-11-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208462-002	NINLARO	EQ 3MG BASE	CAPSULE / ORAL	RLD	2015-11-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208462-003	NINLARO	EQ 4MG BASE	CAPSULE / ORAL	RLD, RS	2015-11-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208462-001	NINLARO	EQ 2.3MG BASE	CAPSULE / ORAL	RLD	2015-11-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208462-002	NINLARO	EQ 3MG BASE	CAPSULE / ORAL	RLD	2015-11-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208462-003	NINLARO	EQ 4MG BASE	CAPSULE / ORAL	RLD, RS	2015-11-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208462-001	NINLARO	EQ 2.3MG BASE	CAPSULE / ORAL	RLD	2015-11-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208462-002	NINLARO	EQ 3MG BASE	CAPSULE / ORAL	RLD	2015-11-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208462-003	NINLARO	EQ 4MG BASE	CAPSULE / ORAL	RLD, RS	2015-11-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208462-001	NINLARO	EQ 2.3MG BASE	CAPSULE / ORAL	RLD	2015-11-20	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 27 · 1,071 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	N208462-001	7687662	2027-08-06		Drug substance, Drug product	2015-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208462-001	8003819	2027-08-06	U-2434	Drug substance, Drug product	2015-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208462-001	8530694	2027-08-06	U-2434	Drug substance, Drug product	2015-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208462-001	8871745	2027-08-06	U-2434		2015-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208462-001	8859504	2029-06-16		Drug substance, Drug product	2015-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208462-001	9175017	2029-06-16	U-2434		2015-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208462-001	7442830	2029-11-20	U-2434	Drug substance, Drug product	2015-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208462-002	7687662	2027-08-06		Drug substance, Drug product	2015-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208462-002	8003819	2027-08-06	U-2434	Drug substance, Drug product	2015-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208462-002	8530694	2027-08-06	U-2434	Drug substance, Drug product	2015-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208462-002	8871745	2027-08-06	U-2434		2015-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208462-002	8859504	2029-06-16		Drug substance, Drug product	2015-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208462-002	9175017	2029-06-16	U-2434		2015-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208462-002	7442830	2029-11-20	U-2434	Drug substance, Drug product	2015-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208462-003	7687662	2027-08-06		Drug substance, Drug product	2015-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208462-003	8003819	2027-08-06	U-2434	Drug substance, Drug product	2015-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208462-003	8530694	2027-08-06	U-2434	Drug substance, Drug product	2015-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208462-003	8871745	2027-08-06	U-2434		2015-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208462-003	8859504	2029-06-16		Drug substance, Drug product	2015-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208462-003	9175017	2029-06-16	U-2434		2015-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208462-003	7442830	2029-11-20	U-2434	Drug substance, Drug product	2015-12-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208462-001	7687662	2027-08-06		Drug substance, Drug product	2015-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208462-001	8003819	2027-08-06	U-2434	Drug substance, Drug product	2015-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208462-001	8530694	2027-08-06	U-2434	Drug substance, Drug product	2015-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208462-001	8871745	2027-08-06	U-2434		2015-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208462-001	8859504	2029-06-16		Drug substance, Drug product	2015-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208462-001	9175017	2029-06-16	U-2434		2015-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208462-001	7442830	2029-11-20	U-2434	Drug substance, Drug product	2015-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208462-002	7687662	2027-08-06		Drug substance, Drug product	2015-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208462-002	8003819	2027-08-06	U-2434	Drug substance, Drug product	2015-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208462-002	8530694	2027-08-06	U-2434	Drug substance, Drug product	2015-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208462-002	8871745	2027-08-06	U-2434		2015-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208462-002	8859504	2029-06-16		Drug substance, Drug product	2015-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208462-002	9175017	2029-06-16	U-2434		2015-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208462-002	7442830	2029-11-20	U-2434	Drug substance, Drug product	2015-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208462-003	7687662	2027-08-06		Drug substance, Drug product	2015-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208462-003	8003819	2027-08-06	U-2434	Drug substance, Drug product	2015-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208462-003	8530694	2027-08-06	U-2434	Drug substance, Drug product	2015-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208462-003	8871745	2027-08-06	U-2434		2015-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208462-003	8859504	2029-06-16		Drug substance, Drug product	2015-12-14	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208462-001	ODE-103	2022-11-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208462-002	ODE-103	2022-11-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208462-003	ODE-103	2022-11-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208462-001	ODE-103	2022-11-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208462-002	ODE-103	2022-11-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208462-003	ODE-103	2022-11-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208462-001	ODE-103	2022-11-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N208462-002	ODE-103	2022-11-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N208462-003	ODE-103	2022-11-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208462-001	NCE	2020-11-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208462-001	ODE-103	2022-11-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208462-002	NCE	2020-11-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208462-002	ODE-103	2022-11-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208462-003	NCE	2020-11-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208462-003	ODE-103	2022-11-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208462-001	ODE-103	2022-11-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N208462-002	ODE-103	2022-11-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N208462-003	ODE-103	2022-11-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208462-001	ODE-103	2022-11-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N208462-002	ODE-103	2022-11-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N208462-003	ODE-103	2022-11-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208462-001	ODE-103	2022-11-20	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208462-002	ODE-103	2022-11-20	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208462-003	ODE-103	2022-11-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208462-001	ODE-103	2022-11-20	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N208462-002	ODE-103	2022-11-20	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N208462-003	ODE-103	2022-11-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208462-001	NCE	2020-11-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208462-001	ODE-103	2022-11-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208462-002	NCE	2020-11-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208462-002	ODE-103	2022-11-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208462-003	NCE	2020-11-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208462-003	ODE-103	2022-11-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208462-001	NCE	2020-11-20	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N208462-001	ODE-103	2022-11-20	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N208462-002	NCE	2020-11-20	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N208462-002	ODE-103	2022-11-20	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N208462-003	NCE	2020-11-20	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N208462-003	ODE-103	2022-11-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208462-001	NCE	2020-11-20	`3f01610625f2…`

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
NINLARO	IXAZOMIB	Takeda Pharmaceuticals America, Inc.	038f2461-834b-4488-9ebd-863c83eef5a7	2025-08-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208462 application number: NDA208462 ndc (product): 63020-400 ndc (product): 63020-390 ndc (product): 63020-230

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63020-078	NINLARO	ixazomib	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-078	NINLARO	ixazomib	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-078	NINLARO	ixazomib	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-079	NINLARO	ixazomib	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-079	NINLARO	ixazomib	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-079	NINLARO	ixazomib	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-080	NINLARO	ixazomib	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-080	NINLARO	ixazomib	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-080	NINLARO	ixazomib	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-230	NINLARO	ixazomib	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-230	NINLARO	ixazomib	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-230	NINLARO	ixazomib	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-230	NINLARO	ixazomib	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-230	NINLARO	ixazomib	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-230	NINLARO	ixazomib	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-230	NINLARO	ixazomib	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-390	NINLARO	ixazomib	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-390	NINLARO	ixazomib	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-390	NINLARO	ixazomib	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-390	NINLARO	ixazomib	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-390	NINLARO	ixazomib	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-390	NINLARO	ixazomib	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-390	NINLARO	ixazomib	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-400	NINLARO	ixazomib	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-400	NINLARO	ixazomib	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-400	NINLARO	ixazomib	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-400	NINLARO	ixazomib	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-400	NINLARO	ixazomib	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-400	NINLARO	ixazomib	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-400	NINLARO	ixazomib	Takeda Pharmaceuticals America, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78982	SUPPL	2024-07-05
78959	SUPPL	2024-07-02
77704	SUPPL	2024-03-04
77691	SUPPL	2024-03-04
70856	SUPPL	2022-04-29
70855	SUPPL	2022-04-29
66740	SUPPL	2021-03-11
66739	SUPPL	2021-03-11
64579	SUPPL	2020-09-15
64578	SUPPL	2020-09-15
64563	SUPPL	2020-09-11
64562	SUPPL	2020-09-11
61981	SUPPL	2020-02-27
61956	SUPPL	2020-02-25
45998	SUPPL	2016-12-01
45956	SUPPL	2016-11-25
43548	ORIG	2015-12-30
44976	ORIG	2015-12-01
40634	ORIG	2015-11-20
10656	ORIG	2015-11-20