Last Updated: November 8, 2026

Details for New Drug Application (NDA): 021794

NDA 021794 describes ACZONE, which is a drug marketed by Almirall and is included in two NDAs. It is available from two suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the ACZONE profile page.

The generic ingredient in ACZONE is dapsone. There is one drug master file entry for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the dapsone profile page.

Summary for 021794

Tradename:	ACZONE
Applicant:	Almirall
Ingredient:	dapsone
Patents:	0

Medical Subject Heading (MeSH) Categories for 021794

Anti-Infective Agents
Antimalarials
Folic Acid Antagonists
Leprostatic Agents

Suppliers and Packaging for NDA: 021794

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ACZONE	dapsone	GEL;TOPICAL	021794	NDA AUTHORIZED GENERIC	Pacific Pharma, Inc.	60758-670	60758-670-30	1 TUBE in 1 CARTON (60758-670-30) / 30 g in 1 TUBE
ACZONE	dapsone	GEL;TOPICAL	021794	NDA AUTHORIZED GENERIC	Pacific Pharma, Inc.	60758-670	60758-670-60	1 TUBE in 1 CARTON (60758-670-60) / 60 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TOPICAL			Strength	5%
Approval Date:	Jul 7, 2005	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021794

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Almirall	ACZONE	dapsone	GEL;TOPICAL	021794-001	Jul 7, 2005	⤷ Start Trial	⤷ Start Trial
Almirall	ACZONE	dapsone	GEL;TOPICAL	021794-001	Jul 7, 2005	⤷ Start Trial	⤷ Start Trial
Almirall	ACZONE	dapsone	GEL;TOPICAL	021794-001	Jul 7, 2005	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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