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Generated: May 26, 2017

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Details for New Drug Application (NDA): 021928

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NDA 021928 describes CHANTIX, which is a drug marketed by Pfizer Inc and is included in one NDA. It is available from ten suppliers. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the CHANTIX profile page.

The generic ingredient in CHANTIX is varenicline tartrate. There are seven drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the varenicline tartrate profile page.

Summary for NDA: 021928

Therapeutic Class:Antidotes, Deterrents, and Toxicologic Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 021928

Suppliers and Packaging for NDA: 021928

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
varenicline tartrate
TABLET;ORAL 021928 NDA Pfizer Laboratories Div Pfizer Inc 0069-0468 0069-0468-56 56 TABLET, FILM COATED in 1 BOTTLE (0069-0468-56)
varenicline tartrate
TABLET;ORAL 021928 NDA Pfizer Laboratories Div Pfizer Inc 0069-0469 0069-0469-03 1 BLISTER PACK in 1 CARTON (0069-0469-03) > 56 TABLET, FILM COATED in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 0.5MG BASE
Approval Date:May 10, 2006TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 12, 2019
Regulatory Exclusivity Use:
Regulatory Exclusivity Expiration:Dec 16, 2019
Regulatory Exclusivity Use:
Patent:6,410,550Patent Expiration:May 10, 2020Product Flag?YSubstance Flag?YDelist Request?

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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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