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ACTIVE SUBSTANCE / INN

OSIMERTINIB MESYLATE

Brand name(s): TAGRISSO, OSIMERTINIB MESYLATE
FDA LISTED
PRESCRIPTION
NONE (TENTATIVE APPROVAL)
NDA208065
ANDA214263
ACTIVE SUBSTANCE
Osimertinib Mesylate
REGULATORS
FDA
SPONSORS / MAH
ZYDUS PHARMS USA INC, ASTRAZENECA
TOTAL APPLICATIONS
2
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
TAGRISSONDA208065ASTRAZENECAPrescription
OSIMERTINIB MESYLATEANDA214263ZYDUS PHARMS USA INCNone (Tentative Approval)

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