Application 205494

Type: NDA
Sponsor: GENZYME CORP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CERDELGA	ELIGLUSTAT TARTRATE	CAPSULE;ORAL	EQ 84MG BASE	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N205494-001	CERDELGA	ELIGLUSTAT TARTRATE	EQ 84MG BASE	CAPSULE / ORAL	AB	RLD, RS	2014-08-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N205494-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N205494-001	7196205	2026-06-26		Drug substance	2014-10-21
N205494-001	11458119	2030-11-24		Drug substance, Drug product	2022-11-02
N205494-001	10888547	2031-01-31	U-3042		2021-01-21
N205494-001	10888547	2031-01-31	U-3043		2021-01-21
N205494-001	12465586	2032-06-05	U-3042		2025-12-05
N205494-001	12465586	2032-06-05	U-3043		2025-12-05
N205494-001	10888544	2038-12-13	U-3040		2021-01-21
N205494-001	10888544	2038-12-13	U-3041		2021-01-21

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 2 · 42 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
2026-08-18 06:07:40	2026-07	N205494-001	CERDELGA	EQ 84MG BASE	CAPSULE / ORAL	AB	RLD, RS	2014-08-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205494-001	CERDELGA	EQ 84MG BASE	CAPSULE / ORAL	AB	RLD, RS	2014-08-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205494-001	CERDELGA	EQ 84MG BASE	CAPSULE / ORAL	AB	RLD, RS	2014-08-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205494-001	CERDELGA	EQ 84MG BASE	CAPSULE / ORAL	AB	RLD, RS	2014-08-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205494-001	CERDELGA	EQ 84MG BASE	CAPSULE / ORAL	AB	RLD, RS	2014-08-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205494-001	CERDELGA	EQ 84MG BASE	CAPSULE / ORAL	AB	RLD, RS	2014-08-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205494-001	CERDELGA	EQ 84MG BASE	CAPSULE / ORAL	AB	RLD, RS	2014-08-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205494-001	CERDELGA	EQ 84MG BASE	CAPSULE / ORAL	AB	RLD, RS	2014-08-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205494-001	CERDELGA	EQ 84MG BASE	CAPSULE / ORAL	AB	RLD, RS	2014-08-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205494-001	CERDELGA	EQ 84MG BASE	CAPSULE / ORAL	AB	RLD, RS	2014-08-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205494-001	CERDELGA	EQ 84MG BASE	CAPSULE / ORAL	AB	RLD, RS	2014-08-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205494-001	CERDELGA	EQ 84MG BASE	CAPSULE / ORAL	AB	RLD, RS	2014-08-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205494-001	CERDELGA	EQ 84MG BASE	CAPSULE / ORAL	AB	RLD, RS	2014-08-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205494-001	CERDELGA	EQ 84MG BASE	CAPSULE / ORAL	AB	RLD, RS	2014-08-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205494-001	CERDELGA	EQ 84MG BASE	CAPSULE / ORAL	AB	RLD, RS	2014-08-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205494-001	CERDELGA	EQ 84MG BASE	CAPSULE / ORAL	AB	RLD, RS	2014-08-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205494-001	CERDELGA	EQ 84MG BASE	CAPSULE / ORAL	AB	RLD, RS	2014-08-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205494-001	CERDELGA	EQ 84MG BASE	CAPSULE / ORAL	AB	RLD, RS	2014-08-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205494-001	CERDELGA	EQ 84MG BASE	CAPSULE / ORAL		RLD, RS	2014-08-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205494-001	CERDELGA	EQ 84MG BASE	CAPSULE / ORAL	AB	RLD, RS	2014-08-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205494-001	CERDELGA	EQ 84MG BASE	CAPSULE / ORAL	AB	RLD, RS	2014-08-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205494-001	CERDELGA	EQ 84MG BASE	CAPSULE / ORAL		RLD, RS	2014-08-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205494-001	CERDELGA	EQ 84MG BASE	CAPSULE / ORAL		RLD, RS	2014-08-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N205494-001	CERDELGA	EQ 84MG BASE	CAPSULE / ORAL		RLD, RS	2014-08-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205494-001	CERDELGA	EQ 84MG BASE	CAPSULE / ORAL		RLD, RS	2014-08-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205494-001	CERDELGA	EQ 84MG BASE	CAPSULE / ORAL		RLD, RS	2014-08-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205494-001	CERDELGA	EQ 84MG BASE	CAPSULE / ORAL		RLD, RS	2014-08-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205494-001	CERDELGA	EQ 84MG BASE	CAPSULE / ORAL		RLD, RS	2014-08-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N205494-001	CERDELGA	EQ 84MG BASE	CAPSULE / ORAL	AB	RLD, RS	2014-08-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N205494-001	CERDELGA	EQ 84MG BASE	CAPSULE / ORAL	AB	RLD, RS	2014-08-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N205494-001	CERDELGA	EQ 84MG BASE	CAPSULE / ORAL	AB	RLD, RS	2014-08-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N205494-001	CERDELGA	EQ 84MG BASE	CAPSULE / ORAL	AB	RLD, RS	2014-08-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N205494-001	CERDELGA	EQ 84MG BASE	CAPSULE / ORAL	AB	RLD, RS	2014-08-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N205494-001	CERDELGA	EQ 84MG BASE	CAPSULE / ORAL	AB	RLD, RS	2014-08-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N205494-001	CERDELGA	EQ 84MG BASE	CAPSULE / ORAL	AB	RLD, RS	2014-08-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N205494-001	CERDELGA	EQ 84MG BASE	CAPSULE / ORAL	AB	RLD, RS	2014-08-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N205494-001	CERDELGA	EQ 84MG BASE	CAPSULE / ORAL	AB	RLD, RS	2014-08-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205494-001	CERDELGA	EQ 84MG BASE	CAPSULE / ORAL	AB	RLD, RS	2014-08-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N205494-001	CERDELGA	EQ 84MG BASE	CAPSULE / ORAL	AB	RLD, RS	2014-08-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N205494-001	CERDELGA	EQ 84MG BASE	CAPSULE / ORAL	AB	RLD, RS	2014-08-19	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N205494-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205494-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205494-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205494-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205494-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205494-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205494-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205494-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205494-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205494-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205494-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205494-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205494-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205494-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205494-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205494-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205494-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205494-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N205494-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205494-001	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N205494-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N205494-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N205494-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N205494-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N205494-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N205494-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N205494-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N205494-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N205494-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205494-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N205494-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N205494-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N205494-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N205494-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 274 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N205494-001	7196205	2026-06-26		Drug substance	2014-10-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205494-001	11458119	2030-11-24		Drug substance, Drug product	2022-11-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205494-001	10888547	2031-01-31	U-3042		2021-01-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205494-001	10888547	2031-01-31	U-3043		2021-01-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205494-001	12465586	2032-06-05	U-3042		2025-12-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205494-001	12465586	2032-06-05	U-3043		2025-12-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205494-001	10888544	2038-12-13	U-3041		2021-01-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205494-001	10888544	2038-12-13	U-3040		2021-01-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205494-001	7196205	2026-06-26		Drug substance	2014-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205494-001	11458119	2030-11-24		Drug substance, Drug product	2022-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205494-001	10888547	2031-01-31	U-3042		2021-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205494-001	10888547	2031-01-31	U-3043		2021-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205494-001	12465586	2032-06-05	U-3042		2025-12-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205494-001	12465586	2032-06-05	U-3043		2025-12-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205494-001	10888544	2038-12-13	U-3041		2021-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205494-001	10888544	2038-12-13	U-3040		2021-01-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205494-001	7196205	2026-06-26		Drug substance	2014-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205494-001	11458119	2030-11-24		Drug substance, Drug product	2022-11-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205494-001	10888547	2031-01-31	U-3042		2021-01-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205494-001	10888547	2031-01-31	U-3043		2021-01-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205494-001	12465586	2032-06-05	U-3042		2025-12-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205494-001	12465586	2032-06-05	U-3043		2025-12-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205494-001	10888544	2038-12-13	U-3041		2021-01-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205494-001	10888544	2038-12-13	U-3040		2021-01-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205494-001	7196205	2026-06-26		Drug substance	2014-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205494-001	11458119	2030-11-24		Drug substance, Drug product	2022-11-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205494-001	10888547	2031-01-31	U-3042		2021-01-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205494-001	10888547	2031-01-31	U-3043		2021-01-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205494-001	10888544	2038-12-13	U-3041		2021-01-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205494-001	10888544	2038-12-13	U-3040		2021-01-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205494-001	7196205	2026-06-26		Drug substance	2014-10-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205494-001	11458119	2030-11-24		Drug substance, Drug product	2022-11-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205494-001	10888547	2031-01-31	U-3042		2021-01-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205494-001	10888547	2031-01-31	U-3043		2021-01-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205494-001	10888544	2038-12-13	U-3041		2021-01-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205494-001	10888544	2038-12-13	U-3040		2021-01-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205494-001	7196205	2026-06-26		Drug substance	2014-10-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205494-001	11458119	2030-11-24		Drug substance, Drug product	2022-11-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205494-001	10888547	2031-01-31	U-3042		2021-01-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205494-001	10888547	2031-01-31	U-3043		2021-01-21	`b8a1b40f171c…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N205494-001	NCE	2019-08-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205494-001	ODE-73	2021-08-19	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N205494-001	ODE-73	2021-08-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205494-001	ODE-73	2021-08-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205494-001	ODE-73	2021-08-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N205494-001	ODE-73	2021-08-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205494-001	ODE-73	2021-08-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205494-001	NCE	2019-08-19	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N205494-001	ODE-73	2021-08-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205494-001	NCE	2019-08-19	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N205494-001	ODE-73	2021-08-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205494-001	NCE	2019-08-19	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N205494-001	ODE-73	2021-08-19	`ea99ee380514…`

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
Cerdelga	ELIGLUSTAT	Genzyme Corporation	819f828a-b888-4e46-83fc-94d774a28a83	2024-03-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205494 application number: NDA205494 ndc (product): 58468-0220

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
58468-0220	Cerdelga	eliglustat	Genzyme Corporation	NDA	Current
58468-0220	Cerdelga	eliglustat	Genzyme Corporation	NDA	Current
58468-0220	Cerdelga	eliglustat	Genzyme Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
56239	SUPPL	2018-11-01
55469	SUPPL	2018-09-13
55376	SUPPL	2018-08-31
52743	ORIG	2018-02-28
24496	ORIG	2014-09-17
22993	ORIG	2014-09-17
19653	ORIG	2014-08-22
10455	ORIG	2014-08-20