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ACTIVE SUBSTANCE / INN

EFAVIRENZ

Brand name(s): EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE, SYMFI LO, EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE, Efavirenz Teva, Stocrin, SUSTIVA, Sustiva, EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE, ATRIPLA, EFAVIRENZ
FDA LISTED
EMA LISTED
DISCONTINUED
PRESCRIPTION
WITHDRAWN
ANDA091579
HIV Infections
ACTIVE SUBSTANCE
Efavirenz
REGULATORS
FDA · EMA
SPONSORS / MAH
BRISTOL MYERS SQUIBB, LAURUS, Teva B.V.
TOTAL APPLICATIONS
13
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
EFAVIRENZANDA090155CIPLA LIMITEDNone (Tentative Approval)
EFAVIRENZANDA091579MACLEODS PHARMS LTDPrescription
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATEANDA091593CIPLA LIMITEDNone (Tentative Approval)
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATEANDA203053HETERO LABS LTD VPrescription
EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATEANDA213038LAURUSPrescription
SUSTIVANDA020972BRISTOL MYERS SQUIBBDiscontinued
ATRIPLANDA021937GILEAD SCIENCESDiscontinued
EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATENDA022343AUROBINDO PHARMA LTDDiscontinued
EFAVIRENZANDA205322AUROBINDO PHARMADiscontinued
SYMFI LONDA208255MYLANDiscontinued
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
SustivaBristol-Myers Squibb Pharma EEIGWithdrawn28/05/1999HIV Infections
StocrinMerck Sharp & Dohme B.V.Authorised28/05/1999HIV Infections
Efavirenz TevaTeva B.V.Authorised09/01/2012HIV Infections

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