Details for New Drug Application (NDA): 021794

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NDA 021794 describes ACZONE, which is a drug marketed by Allergan and Almirall and is included in two NDAs. It is available from three suppliers. There are three patents 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 are eight drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the dapsone profile page.

Summary for 021794

Tradename:	ACZONE
Applicant:	Allergan
Ingredient:	dapsone
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 021794

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	Allergan, Inc.	0023-3670	0023-3670-03	15 TUBE in 1 CARTON (0023-3670-03) / 3 g in 1 TUBE
ACZONE	dapsone	GEL;TOPICAL	021794	NDA	Allergan, Inc.	0023-3670	0023-3670-30	1 TUBE in 1 CARTON (0023-3670-30) / 30 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
Allergan	ACZONE	dapsone	GEL;TOPICAL	021794-001	Jul 7, 2005	⤷ Try a Trial	⤷ Try a Trial
Allergan	ACZONE	dapsone	GEL;TOPICAL	021794-001	Jul 7, 2005	⤷ Try a Trial	⤷ Try a Trial
Allergan	ACZONE	dapsone	GEL;TOPICAL	021794-001	Jul 7, 2005	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.