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Details for New Drug Application (NDA): 020066

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NDA 020066 describes NICORETTE (MINT), which is a drug marketed by Glaxosmithkline and is included in two NDAs. It is available from three suppliers. Additional details are available on the NICORETTE (MINT) profile page.

The generic ingredient in NICORETTE (MINT) is nicotine polacrilex. There are twenty-nine drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the nicotine polacrilex profile page.

Summary for NDA: 020066

Tradename:
NICORETTE
Applicant:
Glaxosmithkline
Ingredient:
nicotine polacrilex
Patents:1
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 020066

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NICORETTE
nicotine polacrilex
GUM, CHEWING;BUCCAL 020066 NDA GlaxoSmithKline Consumer Healthcare LP 0135-0158 0135-0158-07 1 BLISTER PACK in 1 CARTON (0135-0158-07) > 110 GUM, CHEWING in 1 BLISTER PACK
NICORETTE
nicotine polacrilex
GUM, CHEWING;BUCCAL 020066 NDA GlaxoSmithKline Consumer Healthcare LP 0135-0158 0135-0158-10 1 BLISTER PACK in 1 CARTON (0135-0158-10) > 170 GUM, CHEWING in 1 BLISTER PACK

Summary for product number 002

Active Rx/OTC/Discontinued:OTCDosage:GUM, CHEWING;BUCCALStrengthEQ 4MG BASE
Approval Date:Feb 9, 1996TE:RLD:Yes
Patent:8,323,683Patent Expiration:Apr 30, 2028Product Flag?YSubstance Flag?Delist Request?

Summary for product number 003

Active Rx/OTC/Discontinued:OTCDosage:GUM, CHEWING;BUCCALStrengthEQ 4MG BASE
Approval Date:Dec 23, 1998TE:RLD:No

Summary for product number 004

Active Rx/OTC/Discontinued:OTCDosage:GUM, CHEWING;BUCCALStrengthEQ 4MG BASE
Approval Date:Sep 25, 2000TE:RLD:No


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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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