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 1.

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.

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
2026-08-01 22:54:32	2026-06	N208623-001	GALAFOLD	EQ 123MG BASE	CAPSULE / ORAL		RLD, RS	2018-08-10	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 67 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-01 22:54:32	2026-06	N208623-001	10383864	2027-05-16	U-2371		2019-09-04	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208623-001	10406143	2027-05-16	U-2371		2019-09-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208623-001	11241422	2027-05-16	U-2371		2022-02-25	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208623-001	9000011	2027-05-16	U-2371		2018-09-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208623-001	9480682	2027-05-16	U-2371		2018-09-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208623-001	9987263	2027-05-16	U-2371		2018-09-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208623-001	10525045	2028-04-28	U-2371		2020-01-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208623-001	10925866	2028-04-28	U-2371		2021-03-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208623-001	11033538	2028-04-28	U-2371		2021-07-12	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208623-001	12599595	2028-04-28	U-2371		2026-04-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208623-001	9999618	2028-04-28	U-2373		2018-09-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208623-001	9999618	2028-04-28	U-2372		2018-09-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208623-001	10813921	2029-02-12	U-2371		2020-11-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208623-001	8592362	2029-02-12	U-2371	Delist requested	2018-09-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208623-001	9095584	2029-02-12	U-2371		2018-09-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208623-001	RE48608	2031-10-20	U-2371		2021-07-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208623-001	12599594	2036-07-19	U-2371		2026-04-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208623-001	10076514	2037-03-15	U-2371		2018-10-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208623-001	11234972	2037-03-15	U-2371		2022-02-25	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208623-001	10251873	2038-05-30	U-2371		2019-05-07	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208623-001	10471053	2038-05-30	U-2371		2019-12-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208623-001	10792278	2038-05-30	U-2371		2020-10-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208623-001	10792279	2038-05-30	U-2371		2020-10-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208623-001	10799491	2038-05-30	U-2371		2020-11-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208623-001	10806727	2038-05-30	U-2371		2020-11-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208623-001	10849889	2038-05-30	U-2371		2020-12-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208623-001	10849890	2038-05-30	U-2371		2020-12-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208623-001	10857141	2038-05-30	U-2371		2020-12-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208623-001	10857142	2038-05-30	U-2371		2020-12-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208623-001	10874655	2038-05-30	U-2371		2021-01-07	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208623-001	10874656	2038-05-30	U-2371		2021-01-07	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208623-001	10874657	2038-05-30	U-2371		2021-01-07	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208623-001	11278536	2038-05-30	U-2371		2022-04-07	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208623-001	11278537	2038-05-30	U-2371		2022-04-07	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208623-001	11278538	2038-05-30	U-2371		2022-04-07	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208623-001	11278539	2038-05-30	U-2371		2022-04-07	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208623-001	11278540	2038-05-30	U-2371		2022-04-07	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208623-001	11304940	2038-05-30		Drug substance	2022-04-19	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208623-001	11357761	2038-05-30	U-2371		2022-06-28	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N208623-001	11357762	2038-05-30	U-2371		2022-06-28	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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