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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 one supplier. There is one patent 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: | 1 |
| 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: | Try Before You Buy | Patent Expiration: | May 22, 2021 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 005
| Active Rx/OTC/Discontinued: | OTC | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 14MG/24HR | ||||
| Approval Date: | Aug 2, 1996 | TE: | RLD: | Yes | |||||
| Patent: | Try Before You Buy | Patent Expiration: | May 22, 2021 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 006
| Active Rx/OTC/Discontinued: | OTC | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 7MG/24HR | ||||
| Approval Date: | Aug 2, 1996 | TE: | RLD: | Yes | |||||
| Patent: | Try Before You Buy | Patent Expiration: | May 22, 2021 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 020165
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