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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 021794


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NDA 021794 describes ACZONE, which is a drug marketed by Abbvie and Almirall and is included in two NDAs. It is available from three 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 are eight drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the dapsone profile page.
Summary for 021794
Tradename:ACZONE
Applicant:Abbvie
Ingredient:dapsone
Patents:0
Pharmacology for NDA: 021794
Medical Subject Heading (MeSH) Categories for 021794
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:RXDosage:GEL;TOPICALStrength5%
Approval Date:Jul 7, 2005TE:ABRLD:Yes

Expired US Patents for NDA 021794

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

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