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ACTIVE SUBSTANCE / INN

VARENICLINE TARTRATE

Brand name(s): VARENICLINE TARTRATE, CHANTIX, TYRVAYA
FDA LISTED
PRESCRIPTION
DISCONTINUED
NONE (TENTATIVE APPROVAL)
ANDA213268
NDA213978
ACTIVE SUBSTANCE
Varenicline Tartrate
REGULATORS
FDA
SPONSORS / MAH
PF PRISM CV, OYSTER POINT PHARMA, RHODES PHARMS
TOTAL APPLICATIONS
5
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
VARENICLINE TARTRATEANDA214571HETERO LABS LTD IIIPrescription
CHANTIXNDA021928PF PRISM CVPrescription
TYRVAYANDA213978OYSTER POINT PHARMAPrescription
VARENICLINE TARTRATEANDA201808WATSON LABS INCNone (Tentative Approval)
VARENICLINE TARTRATEANDA213268RHODES PHARMSDiscontinued

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