Details for New Drug Application (NDA): 207154

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NDA 207154 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 207154

Tradename:	ACZONE
Applicant:	Almirall
Ingredient:	dapsone
Patents:	3
Formulation / Manufacturing:	see details

Pharmacology for NDA: 207154

Medical Subject Heading (MeSH) Categories for 207154

Anti-Infective Agents
Antimalarials
Folic Acid Antagonists
Leprostatic Agents

Suppliers and Packaging for NDA: 207154

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ACZONE	dapsone	GEL;TOPICAL	207154	NDA	Allergan, Inc.	0023-5206	0023-5206-30	1 BOTTLE, PUMP in 1 CARTON (0023-5206-30) / 30 g in 1 BOTTLE, PUMP
ACZONE	dapsone	GEL;TOPICAL	207154	NDA	Allergan, Inc.	0023-5206	0023-5206-60	1 BOTTLE, PUMP in 1 CARTON (0023-5206-60) / 60 g in 1 BOTTLE, PUMP

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TOPICAL			Strength	7.5%
Approval Date:	Feb 24, 2016	TE:	AB	RLD:	Yes
Regulatory Exclusivity Expiration:	Sep 10, 2022
Regulatory Exclusivity Use:	NEW PATIENT POPULATION
Patent:	⤷ Try a Trial	Patent Expiration:	Nov 18, 2033	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Try a Trial	Patent Expiration:	Nov 18, 2033	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 207154

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Almirall	ACZONE	dapsone	GEL;TOPICAL	207154-001	Feb 24, 2016	⤷ Try a Trial	⤷ Try a Trial
Almirall	ACZONE	dapsone	GEL;TOPICAL	207154-001	Feb 24, 2016	⤷ Try a Trial	⤷ Try a Trial
Almirall	ACZONE	dapsone	GEL;TOPICAL	207154-001	Feb 24, 2016	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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