Application 208623

Type: NDA
Sponsor: AMICUS THERAPS US

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GALAFOLD	MIGALASTAT HYDROCHLORIDE	CAPSULE;ORAL	EQ 123MG 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
N208623-001	GALAFOLD	MIGALASTAT HYDROCHLORIDE	EQ 123MG BASE	CAPSULE / ORAL		RLD, RS	2018-08-10

Orange Book patents#

Current patent rows page 1 of 1 · 67 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208623-001	10383864	2027-05-16	U-2371		2019-09-04
N208623-001	10406143	2027-05-16	U-2371		2019-09-26
N208623-001	11241422	2027-05-16	U-2371		2022-02-25
N208623-001	9000011	2027-05-16	U-2371		2018-09-05
N208623-001	9480682	2027-05-16	U-2371		2018-09-05
N208623-001	9987263	2027-05-16	U-2371		2018-09-05
N208623-001	10525045	2028-04-28	U-2371		2020-01-17
N208623-001	10925866	2028-04-28	U-2371		2021-03-18
N208623-001	11033538	2028-04-28	U-2371		2021-07-12
N208623-001	12599595	2028-04-28	U-2371		2026-04-24
N208623-001	9999618	2028-04-28	U-2372		2018-09-05
N208623-001	9999618	2028-04-28	U-2373		2018-09-05
N208623-001	10813921	2029-02-12	U-2371		2020-11-18
N208623-001	8592362	2029-02-12	U-2371	Delist requested	2018-09-05
N208623-001	9095584	2029-02-12	U-2371		2018-09-05
N208623-001	RE48608	2031-10-20	U-2371		2021-07-22
N208623-001	12599594	2036-07-19	U-2371		2026-04-24
N208623-001	10076514	2037-03-15	U-2371		2018-10-18
N208623-001	11234972	2037-03-15	U-2371		2022-02-25
N208623-001	10251873	2038-05-30	U-2371		2019-05-07
N208623-001	10471053	2038-05-30	U-2371		2019-12-06
N208623-001	10792278	2038-05-30	U-2371		2020-10-15
N208623-001	10792279	2038-05-30	U-2371		2020-10-15
N208623-001	10799491	2038-05-30	U-2371		2020-11-05
N208623-001	10806727	2038-05-30	U-2371		2020-11-05
N208623-001	10849889	2038-05-30	U-2371		2020-12-17
N208623-001	10849890	2038-05-30	U-2371		2020-12-17
N208623-001	10857141	2038-05-30	U-2371		2020-12-17
N208623-001	10857142	2038-05-30	U-2371		2020-12-17
N208623-001	10874655	2038-05-30	U-2371		2021-01-07
N208623-001	10874656	2038-05-30	U-2371		2021-01-07
N208623-001	10874657	2038-05-30	U-2371		2021-01-07
N208623-001	11278536	2038-05-30	U-2371		2022-04-07
N208623-001	11278537	2038-05-30	U-2371		2022-04-07
N208623-001	11278538	2038-05-30	U-2371		2022-04-07
N208623-001	11278539	2038-05-30	U-2371		2022-04-07
N208623-001	11278540	2038-05-30	U-2371		2022-04-07
N208623-001	11304940	2038-05-30		Drug substance	2022-04-19
N208623-001	11357761	2038-05-30	U-2371		2022-06-28
N208623-001	11357762	2038-05-30	U-2371		2022-06-28
N208623-001	11357763	2038-05-30	U-2371		2022-06-28
N208623-001	11357764	2038-05-30		Drug substance	2022-06-28
N208623-001	11357765	2038-05-30		Drug substance	2022-06-28
N208623-001	11376244	2038-05-30		Drug substance	2022-07-25
N208623-001	11389436	2038-05-30	U-2371		2022-07-25
N208623-001	11389437	2038-05-30	U-2371		2022-07-25
N208623-001	11426396	2038-05-30		Drug substance	2022-09-02
N208623-001	11458128	2038-05-30	U-2371		2022-10-13
N208623-001	11612593	2038-05-30		Drug substance	2023-04-17
N208623-001	11612594	2038-05-30		Drug substance	2023-04-17
N208623-001	11633387	2038-05-30		Drug substance	2023-05-12
N208623-001	11666564	2038-05-30	U-2371		2023-06-09
N208623-001	11786516	2038-05-30		Drug substance	2023-10-25
N208623-001	11813255	2038-05-30	U-2371		2023-12-08
N208623-001	12042488	2038-05-30		Drug substance	2024-07-30
N208623-001	12042489	2038-05-30	U-2371	Drug substance	2024-07-30
N208623-001	12042490	2038-05-30	U-2371		2024-07-30
N208623-001	12109205	2038-05-30	U-2371	Drug substance	2024-10-15
N208623-001	12280042	2038-05-30	U-2371	Drug substance	2025-05-07
N208623-001	11903938	2038-08-17	U-2371	Drug substance	2024-03-04
N208623-001	11357784	2039-02-06	U-2371		2022-06-28
N208623-001	11826360	2039-02-16		Drug substance	2023-12-08
N208623-001	11642334	2039-02-20	U-2371		2023-05-12
N208623-001	11622962	2039-03-17		Drug substance	2023-04-17
N208623-001	11633388	2039-03-25	U-2371		2023-05-12
N208623-001	12594268	2041-05-23	U-2371		2026-04-24
N208623-001	11833164	2042-01-11	U-2371		2023-12-08

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N208623-001	GALAFOLD	EQ 123MG BASE	CAPSULE / ORAL	RLD, RS	2018-08-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208623-001	GALAFOLD	EQ 123MG BASE	CAPSULE / ORAL	RLD, RS	2018-08-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208623-001	GALAFOLD	EQ 123MG BASE	CAPSULE / ORAL	RLD, RS	2018-08-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208623-001	GALAFOLD	EQ 123MG BASE	CAPSULE / ORAL	RLD, RS	2018-08-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208623-001	GALAFOLD	EQ 123MG BASE	CAPSULE / ORAL	RLD, RS	2018-08-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208623-001	GALAFOLD	EQ 123MG BASE	CAPSULE / ORAL	RLD, RS	2018-08-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208623-001	GALAFOLD	EQ 123MG BASE	CAPSULE / ORAL	RLD, RS	2018-08-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208623-001	GALAFOLD	EQ 123MG BASE	CAPSULE / ORAL	RLD, RS	2018-08-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208623-001	GALAFOLD	EQ 123MG BASE	CAPSULE / ORAL	RLD, RS	2018-08-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208623-001	GALAFOLD	EQ 123MG BASE	CAPSULE / ORAL	RLD, RS	2018-08-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208623-001	GALAFOLD	EQ 123MG BASE	CAPSULE / ORAL	RLD, RS	2018-08-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208623-001	GALAFOLD	EQ 123MG BASE	CAPSULE / ORAL	RLD, RS	2018-08-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208623-001	GALAFOLD	EQ 123MG BASE	CAPSULE / ORAL	RLD, RS	2018-08-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208623-001	GALAFOLD	EQ 123MG BASE	CAPSULE / ORAL	RLD, RS	2018-08-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208623-001	GALAFOLD	EQ 123MG BASE	CAPSULE / ORAL	RLD, RS	2018-08-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208623-001	GALAFOLD	EQ 123MG BASE	CAPSULE / ORAL	RLD, RS	2018-08-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208623-001	GALAFOLD	EQ 123MG BASE	CAPSULE / ORAL	RLD, RS	2018-08-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208623-001	GALAFOLD	EQ 123MG BASE	CAPSULE / ORAL	RLD, RS	2018-08-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208623-001	GALAFOLD	EQ 123MG BASE	CAPSULE / ORAL	RLD, RS	2018-08-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208623-001	GALAFOLD	EQ 123MG BASE	CAPSULE / ORAL	RLD, RS	2018-08-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208623-001	GALAFOLD	EQ 123MG BASE	CAPSULE / ORAL	RLD, RS	2018-08-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208623-001	GALAFOLD	EQ 123MG BASE	CAPSULE / ORAL	RLD, RS	2018-08-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208623-001	GALAFOLD	EQ 123MG BASE	CAPSULE / ORAL	RLD, RS	2018-08-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208623-001	GALAFOLD	EQ 123MG BASE	CAPSULE / ORAL	RLD, RS	2018-08-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208623-001	GALAFOLD	EQ 123MG BASE	CAPSULE / ORAL	RLD, RS	2018-08-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208623-001	GALAFOLD	EQ 123MG BASE	CAPSULE / ORAL	RLD, RS	2018-08-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208623-001	GALAFOLD	EQ 123MG BASE	CAPSULE / ORAL	RLD, RS	2018-08-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208623-001	GALAFOLD	EQ 123MG BASE	CAPSULE / ORAL	RLD, RS	2018-08-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208623-001	GALAFOLD	EQ 123MG BASE	CAPSULE / ORAL	RLD, RS	2018-08-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208623-001	GALAFOLD	EQ 123MG BASE	CAPSULE / ORAL	RLD, RS	2018-08-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208623-001	GALAFOLD	EQ 123MG BASE	CAPSULE / ORAL	RLD, RS	2018-08-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208623-001	GALAFOLD	EQ 123MG BASE	CAPSULE / ORAL	RLD, RS	2018-08-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208623-001	GALAFOLD	EQ 123MG BASE	CAPSULE / ORAL	RLD, RS	2018-08-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208623-001	GALAFOLD	EQ 123MG BASE	CAPSULE / ORAL	RLD, RS	2018-08-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208623-001	GALAFOLD	EQ 123MG BASE	CAPSULE / ORAL	RLD, RS	2018-08-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208623-001	GALAFOLD	EQ 123MG BASE	CAPSULE / ORAL	RLD, RS	2018-08-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208623-001	GALAFOLD	EQ 123MG BASE	CAPSULE / ORAL	RLD, RS	2018-08-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208623-001	GALAFOLD	EQ 123MG BASE	CAPSULE / ORAL	RLD, RS	2018-08-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208623-001	GALAFOLD	EQ 123MG BASE	CAPSULE / ORAL	RLD, RS	2018-08-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208623-001	GALAFOLD	EQ 123MG BASE	CAPSULE / ORAL	RLD, RS	2018-08-10	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 49 · 1,945 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	N208623-001	10383864	2027-05-16	U-2371		2019-09-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208623-001	10406143	2027-05-16	U-2371		2019-09-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208623-001	11241422	2027-05-16	U-2371		2022-02-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208623-001	9000011	2027-05-16	U-2371		2018-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208623-001	9480682	2027-05-16	U-2371		2018-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208623-001	9987263	2027-05-16	U-2371		2018-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208623-001	10525045	2028-04-28	U-2371		2020-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208623-001	10925866	2028-04-28	U-2371		2021-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208623-001	11033538	2028-04-28	U-2371		2021-07-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208623-001	12599595	2028-04-28	U-2371		2026-04-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208623-001	9999618	2028-04-28	U-2373		2018-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208623-001	9999618	2028-04-28	U-2372		2018-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208623-001	10813921	2029-02-12	U-2371		2020-11-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208623-001	8592362	2029-02-12	U-2371	Delist requested	2018-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208623-001	9095584	2029-02-12	U-2371		2018-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208623-001	RE48608	2031-10-20	U-2371		2021-07-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208623-001	12599594	2036-07-19	U-2371		2026-04-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208623-001	10076514	2037-03-15	U-2371		2018-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208623-001	11234972	2037-03-15	U-2371		2022-02-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208623-001	10251873	2038-05-30	U-2371		2019-05-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208623-001	10471053	2038-05-30	U-2371		2019-12-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208623-001	10792278	2038-05-30	U-2371		2020-10-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208623-001	10792279	2038-05-30	U-2371		2020-10-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208623-001	10799491	2038-05-30	U-2371		2020-11-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208623-001	10806727	2038-05-30	U-2371		2020-11-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208623-001	10849889	2038-05-30	U-2371		2020-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208623-001	10849890	2038-05-30	U-2371		2020-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208623-001	10857141	2038-05-30	U-2371		2020-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208623-001	10857142	2038-05-30	U-2371		2020-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208623-001	10874655	2038-05-30	U-2371		2021-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208623-001	10874656	2038-05-30	U-2371		2021-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208623-001	10874657	2038-05-30	U-2371		2021-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208623-001	11278536	2038-05-30	U-2371		2022-04-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208623-001	11278537	2038-05-30	U-2371		2022-04-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208623-001	11278538	2038-05-30	U-2371		2022-04-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208623-001	11278539	2038-05-30	U-2371		2022-04-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208623-001	11278540	2038-05-30	U-2371		2022-04-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208623-001	11304940	2038-05-30		Drug substance	2022-04-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208623-001	11357761	2038-05-30	U-2371		2022-06-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208623-001	11357762	2038-05-30	U-2371		2022-06-28	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 63 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208623-001	ODE-205	2025-08-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208623-001	ODE-205	2025-08-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208623-001	ODE-205	2025-08-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208623-001	ODE-205	2025-08-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208623-001	ODE-205	2025-08-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208623-001	ODE-205	2025-08-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208623-001	ODE-205	2025-08-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208623-001	ODE-205	2025-08-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208623-001	ODE-205	2025-08-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208623-001	ODE-205	2025-08-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208623-001	ODE-205	2025-08-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208623-001	ODE-205	2025-08-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208623-001	ODE-205	2025-08-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208623-001	NCE	2023-08-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208623-001	ODE-205	2025-08-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208623-001	NCE	2023-08-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208623-001	ODE-205	2025-08-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208623-001	NCE	2023-08-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N208623-001	ODE-205	2025-08-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208623-001	NCE	2023-08-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208623-001	ODE-205	2025-08-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208623-001	NCE	2023-08-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N208623-001	ODE-205	2025-08-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208623-001	NCE	2023-08-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N208623-001	ODE-205	2025-08-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208623-001	NCE	2023-08-10	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208623-001	ODE-205	2025-08-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208623-001	NCE	2023-08-10	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N208623-001	ODE-205	2025-08-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208623-001	NCE	2023-08-10	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208623-001	ODE-205	2025-08-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208623-001	NCE	2023-08-10	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N208623-001	ODE-205	2025-08-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208623-001	NCE	2023-08-10	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N208623-001	ODE-205	2025-08-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208623-001	NCE	2023-08-10	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N208623-001	ODE-205	2025-08-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208623-001	NCE	2023-08-10	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N208623-001	ODE-205	2025-08-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208623-001	ODE-205	2025-08-10	`6a51e52b5d6a…`

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
Galafold	MIGALASTAT HYDROCHLORIDE	Amicus Therapeutics US, LLC	66dbd928-0f1c-48b1-a832-54e4abd9f1db	2025-08-28	Adverse reactions	Exact identifier application applno (NDA): 208623 application number: NDA208623 ndc (product): 71904-100

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71904-100	Galafold	migalastat hydrochloride	Amicus Therapeutics U.S., Inc.	NDA	Current
71904-100	Galafold	migalastat hydrochloride	Amicus Therapeutics U.S., Inc.	NDA	Current
71904-100	Galafold	migalastat hydrochloride	Amicus Therapeutics US, LLC	NDA	Current
71904-100	Galafold	migalastat hydrochloride	Amicus Therapeutics US, LLC	NDA	Current
71904-100	Galafold	migalastat hydrochloride	Amicus Therapeutics U.S., Inc.	NDA	Current
71904-100	Galafold	migalastat hydrochloride	Amicus Therapeutics U.S., Inc.	NDA	Current
71904-100	Galafold	migalastat hydrochloride	Amicus Therapeutics US, LLC	NDA	Current
71904-100	Galafold	migalastat hydrochloride	Amicus Therapeutics U.S., Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81687	SUPPL	2025-03-24
81655	SUPPL	2025-03-20
78724	SUPPL	2024-07-02
78698	SUPPL	2024-06-06
74604	SUPPL	2023-06-22
74603	SUPPL	2023-06-22
74580	SUPPL	2023-06-21
74579	SUPPL	2023-06-21
69556	SUPPL	2021-12-15
69551	SUPPL	2021-12-14
64749	SUPPL	2020-09-29
64737	SUPPL	2020-09-29
59827	SUPPL	2019-08-23
59826	SUPPL	2019-08-23
55432	ORIG	2018-09-11
55172	ORIG	2018-08-14
55165	ORIG	2018-08-10