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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 three 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. Twenty-three suppliers are listed for this compound. Additional details are available on the nicotine profile page.
The generic ingredient in NICODERM CQ is nicotine. There are thirty drug master file entries for this compound. Twenty-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: | 3 |
| 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 | 020165-005 | Aug 2, 1996 | Start Trial | Start Trial |
| Sanofi Aventis Us | NICODERM CQ | nicotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 020165-004 | Aug 2, 1996 | Start Trial | Start Trial |
| Sanofi Aventis Us | NICODERM CQ | nicotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 020165-004 | Aug 2, 1996 | Start Trial | Start Trial |
| Sanofi Aventis Us | NICODERM CQ | nicotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 020165-006 | Aug 2, 1996 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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