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Last Updated: June 18, 2024

Details for New Drug Application (NDA): 022483


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NDA 022483 describes ZYCLARA, which is a drug marketed by Bausch and is included in one NDA. It is available from four suppliers. There are ten patents protecting this drug and two Paragraph IV challenges. Additional details are available on the ZYCLARA profile page.

The generic ingredient in ZYCLARA is imiquimod. There are fourteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the imiquimod profile page.
Summary for 022483
Tradename:ZYCLARA
Applicant:Bausch
Ingredient:imiquimod
Patents:10
Formulation / Manufacturing:see details
Pharmacology for NDA: 022483
Suppliers and Packaging for NDA: 022483
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZYCLARA imiquimod CREAM;TOPICAL 022483 NDA AUTHORIZED GENERIC Teva Pharmaceuticals USA, Inc. 0093-3133 0093-3133-31 1 BOTTLE, PUMP in 1 CARTON (0093-3133-31) / 7.5 g in 1 BOTTLE, PUMP
ZYCLARA imiquimod CREAM;TOPICAL 022483 NDA AUTHORIZED GENERIC Bryant Ranch Prepack 63629-8818 63629-8818-1 1 BOTTLE, PUMP in 1 CARTON (63629-8818-1) / 7.5 g in 1 BOTTLE, PUMP

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength3.75%
Approval Date:Mar 25, 2010TE:ABRLD:Yes
Patent:⤷  Sign UpPatent Expiration:Dec 11, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ACTINIC KERATOSIS
Patent:⤷  Sign UpPatent Expiration:Aug 18, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF GENITAL WARTS
Patent:⤷  Sign UpPatent Expiration:Aug 18, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF PERIANAL WARTS

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