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ACTIVE SUBSTANCE / INN

GEMCITABINE HYDROCHLORIDE

Brand name(s): INLEXZO, GEMCITABINE HYDROCHLORIDE, AVGEMSI, INFUGEM, GEMZAR
FDA LISTED
PRESCRIPTION
DISCONTINUED
NONE (TENTATIVE APPROVAL)
ANDA210383
ANDA205242
ACTIVE SUBSTANCE
Gemcitabine Hydrochloride
REGULATORS
FDA
SPONSORS / MAH
JANSSEN BIOTECH, MYLAN LABS LTD, NOVAST LABS
TOTAL APPLICATIONS
8
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
GEMCITABINE HYDROCHLORIDEANDA205242MYLAN LABS LTDPrescription
INFUGEMNDA208313SUN PHARMDiscontinued
GEMCITABINE HYDROCHLORIDEANDA210383NOVAST LABSDiscontinued
AVGEMSINDA219920AVYXA HOLDINGSPrescription
AVGEMSINDA219920AVYXA HOLDINGSDiscontinued
GEMZARNDA020509LILLYDiscontinued
GEMCITABINE HYDROCHLORIDEANDA090242FRESENIUS KABI USANone (Tentative Approval)
INLEXZONDA219683JANSSEN BIOTECHPrescription

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