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Details for New Drug Application (NDA): 021794

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NDA 021794 describes ACZONE, which is a drug marketed by Allergan Inc and Allergan and is included in two NDAs. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the ACZONE profile page.

The generic ingredient in ACZONE is dapsone. There are seven drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the dapsone profile page.

Summary for NDA: 021794

Tradename:
ACZONE
Applicant:
Allergan
Ingredient:
dapsone
Patents:3
Therapeutic Class:Antimycobacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 021794

Ingredient-typeSulfones

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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength5%
Approval Date:Jul 7, 2005TE:RLD:Yes
Patent:5,863,560Patent Expiration:Sep 11, 2016Product Flag?YSubstance Flag?Delist Request?
Patent:6,620,435Patent Expiration:Sep 11, 2016Product Flag?YSubstance Flag?Delist Request?
Patent:6,060,085Patent Expiration:Sep 11, 2016Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ACNE

Expired Orange Book Patents for NDA: 021794

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan
ACZONE
dapsone
GEL;TOPICAL021794-001Jul 7, 20055,863,560► subscribe
Allergan
ACZONE
dapsone
GEL;TOPICAL021794-001Jul 7, 20056,620,435► subscribe
Allergan
ACZONE
dapsone
GEL;TOPICAL021794-001Jul 7, 20056,060,085► subscribe
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