ACTIVE SUBSTANCE / INN

TENOFOVIR DISOPROXIL FUMARATE

Brand name(s): EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE, DOLUTEGRAVIR; TENOFOVIR DISOPROXIL FUMARATE; LAMIVUDINE, VIREAD, DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE, EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE, TENOFOVIR DISOPROXIL FUMARATE, DELSTRIGO, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE, EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE
FDA LISTED
PRESCRIPTION
NONE (TENTATIVE APPROVAL)
ANDA079071
NDA217016
ACTIVE SUBSTANCE
Tenofovir Disoproxil Fumarate
REGULATORS
FDA
SPONSORS / MAH
LAURUS LABS LTD, LAURUS, GILEAD SCIENCES INC
TOTAL APPLICATIONS
10
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
TENOFOVIR DISOPROXIL FUMARATEANDA079071PHARMOBEDIENTPrescription
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATEANDA091593CIPLA LIMITEDNone (Tentative Approval)
VIREADNDA021356GILEAD SCIENCES INCPrescription
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATEANDA203053HETERO LABS LTD VPrescription
LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATENDA207315HETERO LABS LTD IIINone (Tentative Approval)
DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATENDA210787LAURUS LABS LTDNone (Tentative Approval)
DELSTRIGONDA210807MSD MERCK COPrescription
EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATEANDA213038LAURUSPrescription
DOLUTEGRAVIR; TENOFOVIR DISOPROXIL FUMARATE; LAMIVUDINENDA217016STRIDES PHARMANone (Tentative Approval)
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEANDA204131CHARTWELL RXPrescription

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