ACTIVE SUBSTANCE / INN

OLAPARIB

Brand name(s): OLAPARIB, Lynparza, LYNPARZA
FDA LISTED
EMA LISTED
PRESCRIPTION
DISCONTINUED
AUTHORISED
NDA208558
ANDA217936
ACTIVE SUBSTANCE
Olaparib
REGULATORS
FDA · EMA
SPONSORS / MAH
SANDOZ INC, ASTRAZENECA, AstraZeneca AB
TOTAL APPLICATIONS
4
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
OLAPARIBANDA217936SANDOZ INCNone (Tentative Approval)
LYNPARZANDA206162ASTRAZENECADiscontinued
LYNPARZANDA208558ASTRAZENECAPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
LynparzaAstraZeneca ABAuthorised16/12/2014Ovarian Neoplasms;Breast Neoplasms;Pancreatic Neoplasms;Prostatic Neoplasms, Cas…

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