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ACTIVE SUBSTANCE / INN

DARUNAVIR ETHANOLATE

Brand name(s): PREZCOBIX PED, DARUNAVIR ETHANOLATE, PREZCOBIX
FDA LISTED
PRESCRIPTION
NONE (TENTATIVE APPROVAL)
NDA220092
NDA205395
ACTIVE SUBSTANCE
Darunavir Ethanolate
REGULATORS
FDA
SPONSORS / MAH
MICRO LABS USA, JANSSEN PRODS
TOTAL APPLICATIONS
3
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
DARUNAVIR ETHANOLATEANDA210187MICRO LABS USANone (Tentative Approval)
PREZCOBIX PEDNDA220092JANSSEN PRODSPrescription
PREZCOBIXNDA205395JANSSEN PRODSPrescription

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