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ACTIVE SUBSTANCE / INN

LAMIVUDINE

Brand name(s): LAMIVUDINE, Lamivudine Teva Pharma B.V., Epivir, ABACAVIR SULFATE AND LAMIVUDINE, ABACAVIR SULFATE; LAMIVUDINE, LAMIVUDINE, NEVIRAPINE AND ZIDOVUDINE, DUTREBIS, LAMIVUDINE; ZIDOVUDINE, Lamivudine Teva, LAMIVUDINE AND ZIDOVUDINE, ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE, Zeffix
FDA LISTED
EMA LISTED
PRESCRIPTION
DISCONTINUED
AUTHORISED
NDA205626
ANDA078850
ACTIVE SUBSTANCE
Lamivudine
REGULATORS
FDA · EMA
SPONSORS / MAH
Teva B.V. , LUPIN LTD, Teva B.V.
TOTAL APPLICATIONS
14
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
LAMIVUDINEANDA078850INVAGEN PHARMSNone (Tentative Approval)
LAMIVUDINEANDA090457STRIDES PHARMAPrescription
LAMIVUDINE AND ZIDOVUDINEANDA090679MACLEODS PHARMS LTDPrescription
LAMIVUDINE; ZIDOVUDINENDA201151CIPLA LIMITEDNone (Tentative Approval)
ABACAVIR SULFATE; LAMIVUDINENDA202007CIPLA LIMITEDNone (Tentative Approval)
ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINEANDA202912LUPIN LTDDiscontinued
LAMIVUDINEANDA203586BRECKENRIDGEDiscontinued
ABACAVIR SULFATE AND LAMIVUDINENDA204311PHARMOBEDIENTDiscontinued
LAMIVUDINE, NEVIRAPINE AND ZIDOVUDINENDA205626MICRO LABSDiscontinued
DUTREBISNDA206510MERCK SHARP DOHMEDiscontinued
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
ZeffixGlaxoSmithKline Trading Services LimitedAuthorised29/07/1999Hepatitis B, Chronic
Lamivudine TevaTeva B.V.Authorised23/10/2009Hepatitis B, Chronic
Lamivudine Teva Pharma B.V.Teva B.V. Authorised10/12/2009HIV Infections
EpivirViiV Healthcare BVAuthorised08/08/1996HIV Infections

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