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Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022483

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NDA 022483 describes ZYCLARA, which is a drug marketed by Medicis and is included in one NDA. It is available from one supplier. There are four 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. Nine suppliers are listed for this compound. Additional details are available on the imiquimod profile page.

Summary for 022483

Tradename:1
Applicant:1
Ingredient:1
Patents:4
Therapeutic Class:Dermatological Agents
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 Valeant Pharmaceuticals North America LLC 99207-270 99207-270-01 4 PACKET in 1 CARTON (99207-270-01) > .25 g in 1 PACKET
ZYCLARA imiquimod CREAM;TOPICAL 022483 NDA Valeant Pharmaceuticals North America LLC 99207-270 99207-270-28 28 PACKET in 1 CARTON (99207-270-28) > .25 g in 1 PACKET

Summary for product number 001

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


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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 verifification 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.

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