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Details for New Drug Application (NDA): 020723

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NDA 020723 describes ALDARA, which is a drug marketed by Medicis and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the ALDARA profile page.

The generic ingredient in ALDARA is imiquimod. There are thirteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the imiquimod profile page.

Summary for NDA: 020723

Tradename:
ALDARA
Applicant:
Medicis
Ingredient:
imiquimod
Patents:1
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 020723

Suppliers and Packaging for NDA: 020723

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALDARA
imiquimod
CREAM;TOPICAL 020723 NDA Perrigo New York Inc. 45802-076 45802-076-62 24 PACKET in 1 CARTON (45802-076-62) > 250 mg in 1 PACKET (45802-076-00)
ALDARA
imiquimod
CREAM;TOPICAL 020723 NDA Valeant Pharmaceuticals North America LLC 99207-260 99207-260-01 4 PACKET in 1 CARTON (99207-260-01) > .25 g in 1 PACKET

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength5%
Approval Date:Feb 27, 1997TE:ABRLD:Yes
Patent:7,696,159*PEDPatent Expiration:Oct 1, 2024Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 020723

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Medicis
ALDARA
imiquimod
CREAM;TOPICAL020723-001Feb 27, 19974,689,338*PED► subscribe
Medicis
ALDARA
imiquimod
CREAM;TOPICAL020723-001Feb 27, 19975,238,944*PED► subscribe
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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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