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ACTIVE SUBSTANCE / INN

VARENICLINE

Brand name(s): VARENICLINE, Champix
FDA LISTED
EMA LISTED
AUTHORISED
NONE (TENTATIVE APPROVAL)
Tobacco Use Cessation
ANDA201920
ACTIVE SUBSTANCE
Varenicline
REGULATORS
FDA · EMA
SPONSORS / MAH
TEVA PHARMS USA, Pfizer Europe MA EEIG
TOTAL APPLICATIONS
2
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
VARENICLINEANDA201920TEVA PHARMS USANone (Tentative Approval)
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
ChampixPfizer Europe MA EEIGAuthorised25/09/2006Tobacco Use Cessation

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