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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 five 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 twenty-nine drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the nicotine profile page.

Summary for NDA: 020165

Tradename:
NICODERM CQ
Applicant:
Sanofi Aventis Us
Ingredient:
nicotine
Patents:4
Therapeutic Class:Antidotes, Deterrents, and Toxicologic Agents
Formulation / Manufacturing:see details

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 0135-0145 0135-0145-02 14 PATCH in 1 CARTON (0135-0145-02) > 24 h in 1 PATCH
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

Summary for product number 004

Active Rx/OTC/Discontinued:OTCDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength21MG/24HR
Approval Date:Aug 2, 1996TE:RLD:Yes
Patent:8,075,911Patent Expiration:May 22, 2021Product Flag?YSubstance Flag?Delist Request?
Patent:8,663,680Patent Expiration:Feb 13, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:9,205,059Patent Expiration:Dec 15, 2019Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book 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;TRANSDERMAL020165-004Aug 2, 19965,633,008► subscribe
Sanofi Aventis Us
NICODERM CQ
nicotine
FILM, EXTENDED RELEASE;TRANSDERMAL020165-004Aug 2, 19965,344,656► subscribe
Sanofi Aventis Us
NICODERM CQ
nicotine
FILM, EXTENDED RELEASE;TRANSDERMAL020165-005Aug 2, 19965,633,008► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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