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Details for New Drug Application (NDA): 020165
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The generic ingredient in NICODERM CQ is nicotine. There are thirty drug master file entries for this compound. Twenty-six 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 |
Paragraph IV (Patent) Challenges for 020165
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
NICODERM CQ | FILM, EXTENDED RELEASE;TRANSDERMAL | nicotine | 020165 | 2014-05-30 |
Profile for product number 004
Active Rx/OTC/Discontinued: | OTC | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 21MG/24HR | ||||
Approval Date: | Aug 2, 1996 | TE: | RLD: | Yes | |||||
Patent: | Start Trial | Patent Expiration: | May 22, 2021 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | Start Trial | Patent Expiration: | Feb 13, 2020 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | Start Trial | Patent Expiration: | Feb 13, 2020 | Product 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 | Start Trial | Start Trial |
Sanofi Aventis Us | NICODERM CQ | nicotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 020165-005 | Aug 2, 1996 | Start Trial | Start Trial |
Sanofi Aventis Us | NICODERM CQ | nicotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 020165-005 | Aug 2, 1996 | Start Trial | Start Trial |
Sanofi Aventis Us | NICODERM CQ | nicotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 020165-005 | Aug 2, 1996 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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