Application 219474

Type: NDA
Sponsor: ACROTECH BIOPHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ADQUEY	DIFAMILAST	OINTMENT;TOPICAL	1%	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
N219474-001	ADQUEY	DIFAMILAST	1%	OINTMENT / TOPICAL		RLD, RS	2026-02-12

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N219474-001	RE46792	2028-03-01	U-4445	Drug substance, Drug product	2026-03-11
N219474-001	10588893	2036-12-31		Drug substance, Drug product	2026-03-11

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N219474-001	NCE	2031-02-12

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
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219474-001	ADQUEY	1%	OINTMENT / TOPICAL		RLD, RS	2026-02-12	`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
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219474-001	RE46792	2028-03-01	U-4445	Drug substance, Drug product	2026-03-11	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219474-001	10588893	2036-12-31		Drug substance, Drug product	2026-03-11	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219474-001	NCE	2031-02-12	`a50c72e98297…`

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
ADQUEY	DIFAMILAST	Acrotech Biopharma Inc	46c95e41-fa29-4e11-9d94-0fd4f0291c34	2026-02-25	Adverse reactions	Exact identifier application applno (NDA): 219474 application number: NDA219474

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85372	ORIG	2026-03-13
85135	ORIG	2026-02-24
85044	ORIG	2026-02-13