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Generated: November 12, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020165

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NDA 020165 describes NICODERM CQ, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from four suppliers. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the NICODERM CQ profile page.

The generic ingredient in NICODERM CQ is nicotine. There are thirty drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the nicotine profile page.
Summary for 020165
Tradename:NICODERM CQ
Applicant:Sanofi Aventis Us
Ingredient:nicotine
Patents:4
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 020165
Suppliers and Packaging for NDA: 020165
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NICODERM CQ nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020165 NDA GlaxoSmithKline Consumer Healthcare Holdings (US) LLC 0135-0194 0135-0194-01 7 PATCH in 1 CARTON (0135-0194-01) > 24 h in 1 PATCH
NICODERM CQ nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020165 NDA GlaxoSmithKline Consumer Healthcare Holdings (US) LLC 0135-0194 0135-0194-02 14 PATCH in 1 CARTON (0135-0194-02) > 24 h in 1 PATCH

Profile for product number 004

Active Rx/OTC/Discontinued:OTCDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength21MG/24HR
Approval Date:Aug 2, 1996TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:May 22, 2021Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Feb 13, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Feb 13, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:A METHOD TO REDUCE WITHDRAWAL SYMPTOMS, INCLUDING NICOTINE CRAVING, ASSOCIATED WITH SMOKING CESSATION

Expired US Patents for NDA 020165

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us NICODERM CQ nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020165-006 Aug 2, 1996 ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us NICODERM CQ nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020165-004 Aug 2, 1996 ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us NICODERM CQ nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020165-005 Aug 2, 1996 ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us NICODERM CQ nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020165-004 Aug 2, 1996 ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us NICODERM CQ nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020165-006 Aug 2, 1996 ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us NICODERM CQ nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020165-006 Aug 2, 1996 ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us NICODERM CQ nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020165-005 Aug 2, 1996 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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