Application 215211

Type: NDA
Sponsor: AMICUS THERAP US

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OPFOLDA	MIGLUSTAT	CAPSULE;ORAL	65MG	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
N215211-001	OPFOLDA	MIGLUSTAT	65MG	CAPSULE / ORAL		RLD, RS	2023-09-28

Orange Book patents#

Current patent rows page 1 of 1 · 10 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N215211-001	10512677	2033-03-07	U-3726		2023-10-26
N215211-001	11278599	2033-03-07	U-3726		2023-10-26
N215211-001	12419937	2033-03-07	U-3726		2025-10-21
N215211-001	10208299	2035-09-30	U-3726	Drug substance, Drug product	2023-10-26
N215211-001	10961522	2035-09-30	U-3726		2023-10-26
N215211-001	11753632	2035-09-30	U-3726		2023-10-26
N215211-001	11278601	2036-12-29	U-3726	Drug product	2023-10-26
N215211-001	12414985	2036-12-29	U-3726		2025-10-21
N215211-001	10857212	2037-08-12	U-3726		2023-10-26
N215211-001	12246062	2038-09-16	U-3726		2025-03-18

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N215211-001	NP	2026-09-28

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	N215211-001	OPFOLDA	65MG	CAPSULE / ORAL		RLD, RS	2023-09-28	`a50c72e98297…`

Observed Orange Book patent history#

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	N215211-001	10512677	2033-03-07	U-3726		2023-10-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N215211-001	11278599	2033-03-07	U-3726		2023-10-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N215211-001	12419937	2033-03-07	U-3726		2025-10-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N215211-001	10208299	2035-09-30	U-3726	Drug substance, Drug product	2023-10-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N215211-001	10961522	2035-09-30	U-3726		2023-10-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N215211-001	11753632	2035-09-30	U-3726		2023-10-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N215211-001	11278601	2036-12-29	U-3726	Drug product	2023-10-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N215211-001	12414985	2036-12-29	U-3726		2025-10-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N215211-001	10857212	2037-08-12	U-3726		2023-10-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N215211-001	12246062	2038-09-16	U-3726		2025-03-18	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-01 22:54:32	2026-06	N215211-001	NP	2026-09-28	`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
OPFOLDA	MIGLUSTAT	AMICUS THERAPEUTICS US, LLC	d7c38298-37db-5a80-e053-2995a90aee40	2024-11-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 215211 application number: NDA215211

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79239	SUPPL	2024-07-29
79217	SUPPL	2024-07-26
75990	ORIG	2023-10-31
75620	ORIG	2023-09-29
75601	ORIG	2023-09-28