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. 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. Eight suppliers are listed for this compound. Additional details are available on the imiquimod profile page.

Summary for 020723

Tradename:	ALDARA
Applicant:	Bausch
Ingredient:	imiquimod
Patents:	1

Pharmacology for NDA: 020723

Mechanism of Action	Interferon Inducers
Physiological Effect	Increased Cytokine Activity Increased Cytokine Production

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CREAM;TOPICAL			Strength	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Feb 27, 1997	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Oct 1, 2024	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 020723

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	ALDARA	imiquimod	CREAM;TOPICAL	020723-001	Feb 27, 1997	⤷ Sign Up	⤷ Sign Up
Bausch	ALDARA	imiquimod	CREAM;TOPICAL	020723-001	Feb 27, 1997	⤷ Sign Up	⤷ Sign Up
Bausch	ALDARA	imiquimod	CREAM;TOPICAL	020723-001	Feb 27, 1997	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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