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Last Updated: October 15, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020723

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NDA 020723 describes ALDARA, which is a drug marketed by Bausch and is included in one NDA. It is available from one supplier. 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 fourteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the imiquimod profile page.
Summary for 020723
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 Valeant Pharmaceuticals North America LLC 99207-260 99207-260-12 12 PACKET in 1 CARTON (99207-260-12) > .25 g in 1 PACKET

Profile for product number 001

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

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