Application 209606

Type: NDA
Sponsor: CELGENE CORP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IDHIFA	ENASIDENIB MESYLATE	TABLET;ORAL	EQ 50MG BASE	Yes	No
002	IDHIFA	ENASIDENIB MESYLATE	TABLET;ORAL	EQ 100MG 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N209606-001	IDHIFA	ENASIDENIB MESYLATE	EQ 50MG BASE	TABLET / ORAL		RLD	2017-08-01
N209606-002	IDHIFA	ENASIDENIB MESYLATE	EQ 100MG BASE	TABLET / ORAL		RLD, RS	2017-08-01

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209606-001	10610125	2030-06-21	U-2087		2020-05-01
N209606-001	10294215	2033-01-07	U-2087	Drug product	2019-06-20
N209606-001	9512107	2033-01-07	U-2087	Drug substance, Drug product	2017-08-29
N209606-001	10093654	2034-08-01	U-2087	Drug substance, Drug product	2018-11-07
N209606-001	9738625	2034-08-01		Drug substance	2017-08-29
N209606-001	9732062	2034-09-16		Drug substance	2017-08-29
N209606-002	10610125	2030-06-21	U-2087		2020-05-01
N209606-002	10294215	2033-01-07	U-2087	Drug product	2019-06-20
N209606-002	9512107	2033-01-07	U-2087	Drug substance, Drug product	2017-08-29
N209606-002	10093654	2034-08-01	U-2087	Drug substance, Drug product	2018-11-07
N209606-002	9738625	2034-08-01		Drug substance	2017-08-29
N209606-002	9732062	2034-09-16		Drug substance	2017-08-29

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N209606-001	IDHIFA	EQ 50MG BASE	TABLET / ORAL	RLD	2017-08-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209606-002	IDHIFA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2017-08-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209606-001	IDHIFA	EQ 50MG BASE	TABLET / ORAL	RLD	2017-08-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209606-002	IDHIFA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2017-08-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209606-001	IDHIFA	EQ 50MG BASE	TABLET / ORAL	RLD	2017-08-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209606-002	IDHIFA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2017-08-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209606-001	IDHIFA	EQ 50MG BASE	TABLET / ORAL	RLD	2017-08-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209606-002	IDHIFA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2017-08-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209606-001	IDHIFA	EQ 50MG BASE	TABLET / ORAL	RLD	2017-08-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209606-002	IDHIFA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2017-08-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209606-001	IDHIFA	EQ 50MG BASE	TABLET / ORAL	RLD	2017-08-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209606-002	IDHIFA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2017-08-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209606-001	IDHIFA	EQ 50MG BASE	TABLET / ORAL	RLD	2017-08-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209606-002	IDHIFA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2017-08-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209606-001	IDHIFA	EQ 50MG BASE	TABLET / ORAL	RLD	2017-08-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209606-002	IDHIFA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2017-08-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209606-001	IDHIFA	EQ 50MG BASE	TABLET / ORAL	RLD	2017-08-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209606-002	IDHIFA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2017-08-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209606-001	IDHIFA	EQ 50MG BASE	TABLET / ORAL	RLD	2017-08-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209606-002	IDHIFA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2017-08-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209606-001	IDHIFA	EQ 50MG BASE	TABLET / ORAL	RLD	2017-08-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209606-002	IDHIFA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2017-08-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209606-001	IDHIFA	EQ 50MG BASE	TABLET / ORAL	RLD	2017-08-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209606-002	IDHIFA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2017-08-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209606-001	IDHIFA	EQ 50MG BASE	TABLET / ORAL	RLD	2017-08-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209606-002	IDHIFA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2017-08-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209606-001	IDHIFA	EQ 50MG BASE	TABLET / ORAL	RLD	2017-08-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209606-002	IDHIFA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2017-08-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209606-001	IDHIFA	EQ 50MG BASE	TABLET / ORAL	RLD	2017-08-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209606-002	IDHIFA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2017-08-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209606-001	IDHIFA	EQ 50MG BASE	TABLET / ORAL	RLD	2017-08-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209606-002	IDHIFA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2017-08-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209606-001	IDHIFA	EQ 50MG BASE	TABLET / ORAL	RLD	2017-08-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209606-002	IDHIFA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2017-08-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209606-001	IDHIFA	EQ 50MG BASE	TABLET / ORAL	RLD	2017-08-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209606-002	IDHIFA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2017-08-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209606-001	IDHIFA	EQ 50MG BASE	TABLET / ORAL	RLD	2017-08-01	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209606-002	IDHIFA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2017-08-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209606-001	IDHIFA	EQ 50MG BASE	TABLET / ORAL	RLD	2017-08-01	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209606-002	IDHIFA	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2017-08-01	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 13 · 484 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	N209606-001	10610125	2030-06-21	U-2087		2020-05-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209606-001	10294215	2033-01-07	U-2087	Drug product	2019-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209606-001	9512107	2033-01-07	U-2087	Drug substance, Drug product	2017-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209606-001	10093654	2034-08-01	U-2087	Drug substance, Drug product	2018-11-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209606-001	9738625	2034-08-01		Drug substance	2017-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209606-001	9732062	2034-09-16		Drug substance	2017-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209606-002	10610125	2030-06-21	U-2087		2020-05-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209606-002	10294215	2033-01-07	U-2087	Drug product	2019-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209606-002	9512107	2033-01-07	U-2087	Drug substance, Drug product	2017-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209606-002	10093654	2034-08-01	U-2087	Drug substance, Drug product	2018-11-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209606-002	9738625	2034-08-01		Drug substance	2017-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209606-002	9732062	2034-09-16		Drug substance	2017-08-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209606-001	10610125	2030-06-21	U-2087		2020-05-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209606-001	10294215	2033-01-07	U-2087	Drug product	2019-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209606-001	9512107	2033-01-07	U-2087	Drug substance, Drug product	2017-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209606-001	10093654	2034-08-01	U-2087	Drug substance, Drug product	2018-11-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209606-001	9738625	2034-08-01		Drug substance	2017-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209606-001	9732062	2034-09-16		Drug substance	2017-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209606-002	10610125	2030-06-21	U-2087		2020-05-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209606-002	10294215	2033-01-07	U-2087	Drug product	2019-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209606-002	9512107	2033-01-07	U-2087	Drug substance, Drug product	2017-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209606-002	10093654	2034-08-01	U-2087	Drug substance, Drug product	2018-11-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209606-002	9738625	2034-08-01		Drug substance	2017-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209606-002	9732062	2034-09-16		Drug substance	2017-08-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209606-001	10610125	2030-06-21	U-2087		2020-05-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209606-001	10294215	2033-01-07	U-2087	Drug product	2019-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209606-001	9512107	2033-01-07	U-2087	Drug substance, Drug product	2017-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209606-001	10093654	2034-08-01	U-2087	Drug substance, Drug product	2018-11-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209606-001	9738625	2034-08-01		Drug substance	2017-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209606-001	9732062	2034-09-16		Drug substance	2017-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209606-002	10610125	2030-06-21	U-2087		2020-05-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209606-002	10294215	2033-01-07	U-2087	Drug product	2019-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209606-002	9512107	2033-01-07	U-2087	Drug substance, Drug product	2017-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209606-002	10093654	2034-08-01	U-2087	Drug substance, Drug product	2018-11-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209606-002	9738625	2034-08-01		Drug substance	2017-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209606-002	9732062	2034-09-16		Drug substance	2017-08-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209606-001	10610125	2030-06-21	U-2087		2020-05-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209606-001	10294215	2033-01-07	U-2087	Drug product	2019-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209606-001	9512107	2033-01-07	U-2087	Drug substance, Drug product	2017-08-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209606-001	10093654	2034-08-01	U-2087	Drug substance, Drug product	2018-11-07	`fd3edfee7708…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 106 observed states.

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	N209606-001	ODE-151	2024-08-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209606-002	ODE-151	2024-08-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209606-001	ODE-151	2024-08-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209606-002	ODE-151	2024-08-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209606-001	ODE-151	2024-08-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209606-002	ODE-151	2024-08-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209606-001	ODE-151	2024-08-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209606-002	ODE-151	2024-08-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209606-001	ODE-151	2024-08-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209606-002	ODE-151	2024-08-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209606-001	ODE-151	2024-08-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209606-002	ODE-151	2024-08-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209606-001	ODE-151	2024-08-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209606-002	ODE-151	2024-08-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209606-001	ODE-151	2024-08-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209606-002	ODE-151	2024-08-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209606-001	ODE-151	2024-08-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209606-002	ODE-151	2024-08-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209606-001	NCE	2022-08-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209606-001	ODE-151	2024-08-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209606-002	NCE	2022-08-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209606-002	ODE-151	2024-08-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209606-001	NCE	2022-08-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209606-001	ODE-151	2024-08-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209606-002	NCE	2022-08-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209606-002	ODE-151	2024-08-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209606-001	NCE	2022-08-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209606-001	ODE-151	2024-08-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209606-002	NCE	2022-08-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209606-002	ODE-151	2024-08-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209606-001	NCE	2022-08-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209606-001	ODE-151	2024-08-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209606-002	NCE	2022-08-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209606-002	ODE-151	2024-08-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209606-001	NCE	2022-08-01	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209606-001	ODE-151	2024-08-01	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209606-002	NCE	2022-08-01	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209606-002	ODE-151	2024-08-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209606-001	NCE	2022-08-01	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209606-001	ODE-151	2024-08-01	`782e0a99824c…`

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
Idhifa	ENASIDENIB MESYLATE	Celgene Corporation	a5b4cdf0-3fa8-4c6c-80f6-8d8a00e3a5b6	2025-01-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 209606 application number: NDA209606 ndc (product): 59572-710 ndc (product): 59572-705

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59572-705	Idhifa	enasidenib mesylate	Celgene Corporation	NDA	Current
59572-705	Idhifa	enasidenib mesylate	Celgene Corporation	NDA	Current
59572-705	Idhifa	enasidenib mesylate	Celgene Corporation	NDA	Current
59572-705	Idhifa	enasidenib mesylate	Celgene Corporation	NDA	Current
59572-705	Idhifa	enasidenib mesylate	Celgene Corporation	NDA	Current
59572-710	Idhifa	enasidenib mesylate	Celgene Corporation	NDA	Current
59572-710	Idhifa	enasidenib mesylate	Celgene Corporation	NDA	Current
59572-710	Idhifa	enasidenib mesylate	Celgene Corporation	NDA	Current
59572-710	Idhifa	enasidenib mesylate	Celgene Corporation	NDA	Current
59572-710	Idhifa	enasidenib mesylate	Celgene Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80868	SUPPL	2025-01-17
80864	SUPPL	2025-01-17
80863	SUPPL	2025-01-17
80643	SUPPL	2024-12-19
77120	SUPPL	2023-12-22
77111	SUPPL	2023-12-22
68210	SUPPL	2021-07-27
65357	SUPPL	2020-11-27
65333	SUPPL	2020-11-25
65332	SUPPL	2020-11-25
60186	SUPPL	2019-10-01
60185	SUPPL	2019-10-01
60162	SUPPL	2019-09-30
49522	ORIG	2017-08-24
49208	ORIG	2017-08-02
49171	ORIG	2017-08-01
49170	ORIG	2017-08-01