e-Drug3D
1428
cas 201341-05-1
CLASS
ANTIINFECTIVE
ANTIVIRAL
ANTIRETROVIRAL
NUCLEOTIDE ANALOG HIV-1 REVERSE TRANSCRIPTASE INHIBITOR AND
HBV REVERSE TRANSCRIPTASE INHIBITOR
CHRONIC HEPATITIS B IN ADULTS
ROUTE (list)
ORAL
ATC code
J05AR06
J05AR08
J05AR12
J05AR27
J05AR24
J05AR11
J05AF07
J05AR03
PK parameters
Solubility
13.4 MILLIGRAM / MILLILITER
TARGET HIV REVERSE TRANSCRIPTASE
Reverse transcriptase,RNaseH UNIPROT Q72547 pol
Formula:
C19H30N5O10P
Calculated chemical properties:
MW 519.45
NB_atoms 35
XLogP 3.04
PSA 175.763
NB_HD 2
NB_HA 15
fsp3 0.63
Lipinski(0=no;1=yes) 0
NB_atoms 35
XLogP 3.04
PSA 175.763
NB_HD 2
NB_HA 15
fsp3 0.63
Lipinski(0=no;1=yes) 0
FDA
NDA 021356 (label) INN (TENOFOVIR DISOPROXIL FUMARATE) VIREAD (GILEAD SCIENCES INC) APPROVAL= AP YEAR= 2001 NEWMOLECULARENTITY
NDA 021752 (label) INN (EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE) TRUVADA (GILEAD) APPROVAL= AP YEAR= 2004
NDA 021937 (label) INN (EFAVIRENZ ; EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE) ATRIPLA (GILEAD SCIENCES) APPROVAL= AP YEAR= 2006
NDA 090049 (pdf not found) INN (EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE (MATRIX LABS LTD) APPROVAL= TA YEAR= 2009
NDA 090437 (pdf not found) INN (EFAVIRENZ ; EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE (MATRIX LABS LTD) APPROVAL= TA YEAR= 2009
NDA 022459 (pdf not found) INN (LAMIVUDINE ; TENOFOVIR DISOPROXIL FUMARATE) LAMIVUDINE/TENOFOVIR DISOPROXIL FUMARATE FDC TABS (HETERO DRUGS LTD) APPROVAL= TA YEAR= 2009
NDA 200623 (pdf not found) INN (LAMIVUDINE ; TENOFOVIR DISOPROXIL FUMARATE) LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE (CIPLA LIMITED) APPROVAL= TA YEAR= 2011
NDA 202123 (label) INN (EMTRICITABINE ; RILPIVIRINE HYDROCHLORIDE ; TENOFOVIR DISOPROXIL FUMARATE) COMPLERA (GILEAD SCIENCES INC) APPROVAL= AP YEAR= 2011
NDA 202171 (pdf not found) INN (LAMIVUDINE ; TENOFOVIR DISOPROXIL FUMARATE ; NEVIRAPINE) LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE; NEVIRAPINE (MATRIX LABS LTD) APPROVAL= TA YEAR= 2011
NDA 022577 (label) INN (TENOFOVIR DISOPROXIL FUMARATE) VIREAD (GILEAD SCIENCES INC) APPROVAL= AP YEAR= 2012
NDA 091593 (pdf not found) INN (EFAVIRENZ ; EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE (CIPLA LIMITED) APPROVAL= TA YEAR= 2012
NDA 203100 (label) INN (COBICISTAT ; ELVITEGRAVIR ; EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE) STRIBILD (GILEAD SCIENCES INC) APPROVAL= AP YEAR= 2012
NDA 203283 (pdf not found) INN (LAMIVUDINE ; TENOFOVIR DISOPROXIL FUMARATE) LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE (MACLEODS PHARMS LTD) APPROVAL= TA YEAR= 2012
NDA 202529 (pdf not found) INN (LAMIVUDINE ; TENOFOVIR DISOPROXIL FUMARATE) LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE (RANBAXY LABS LTD) APPROVAL= TA YEAR= 2013
NDA 204505 (pdf not found) INN (LAMIVUDINE ; TENOFOVIR DISOPROXIL FUMARATE ; NEVIRAPINE) LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE; NEVIRAPINE (AUROBINDO PHARMA LTD) APPROVAL= TA YEAR= 2013
NDA 204568 (pdf not found) INN (EFAVIRENZ ; LAMIVUDINE ; TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE (CIPLA) APPROVAL= TA YEAR= 2013
NDA 205355 (pdf not found) INN (LAMIVUDINE ; TENOFOVIR DISOPROXIL FUMARATE ; NEVIRAPINE) LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE; NEVIRAPINE (HETERO LABS LTD III) APPROVAL= TA YEAR= 2014
NDA 205861 (pdf not found) INN (EFAVIRENZ ; LAMIVUDINE ; TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE (MACLEODS PHARMS LTD) APPROVAL= TA YEAR= 2014
NDA 206042 (pdf not found) INN (EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE ; NEVIRAPINE) EMTRICITABINE;TENOFOVIR DISOPROXIL FUMARATE;NEVIRAPINE (MYLAN LABS LTD) APPROVAL= TA YEAR= 2014
NDA 091612 (pdf not found) INN (TENOFOVIR DISOPROXIL FUMARATE) TENOFOVIR DISOPROXIL FUMARATE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2015
NDA 204402 (pdf not found) INN (TENOFOVIR DISOPROXIL FUMARATE) TENOFOVIR DISOPROXIL FUMARATE (LUPIN LTD) APPROVAL= TA YEAR= 2015
NDA 206584 (pdf not found) INN (TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE (EMCURE PHARMS LTD) APPROVAL= TA YEAR= 2015 OBSOLETE
NDA 090742 (pdf not found) INN (TENOFOVIR DISOPROXIL FUMARATE) TENOFOVIR DISOPROXIL FUMARATE (STRIDES PHARMA) APPROVAL= AP YEAR= 2016
NDA 203470 (pdf not found) INN (TENOFOVIR DISOPROXIL FUMARATE) TENOFOVIR DISOPROXIL FUMARATE (PHARMACARE LTD) APPROVAL= TA YEAR= 2016 OBSOLETE
NDA 090894 (pdf not found) INN (EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2017
NDA 204119 (pdf not found) INN (EFAVIRENZ ; LAMIVUDINE ; TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE (HETERO DRUGS LTD) APPROVAL= TA YEAR= 2017
NDA 207315 (pdf not found) INN (LAMIVUDINE ; TENOFOVIR DISOPROXIL FUMARATE) LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE (HETERO LABS LTD III) APPROVAL= TA YEAR= 2017
NDA 209670 (pdf not found) INN (DOLUTEGRAVIR ; LAMIVUDINE ; TENOFOVIR DISOPROXIL FUMARATE) DOLUTEGRAVIR, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE (MYLAN PHARMS INC) APPROVAL= TA YEAR= 2017
NDA 022141 (label) INN (LAMIVUDINE ; TENOFOVIR DISOPROXIL FUMARATE) CIMDUO (MYLAN LABS LTD) APPROVAL= AP YEAR= 2018
NDA 022142 (label) INN (EFAVIRENZ ; LAMIVUDINE ; TENOFOVIR DISOPROXIL FUMARATE) SYMFI (MYLAN LABS LTD) APPROVAL= AP YEAR= 2018
NDA 078800 (pdf not found) INN (TENOFOVIR DISOPROXIL FUMARATE) TENOFOVIR DISOPROXIL FUMARATE (CIPLA) APPROVAL= AP YEAR= 2018
NDA 090513 (pdf not found) INN (EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2018
NDA 090636 (pdf not found) INN (TENOFOVIR DISOPROXIL FUMARATE) TENOFOVIR DISOPROXIL FUMARATE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2018
NDA 090647 (pdf not found) INN (TENOFOVIR DISOPROXIL FUMARATE) TENOFOVIR DISOPROXIL FUMARATE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2018
NDA 022344 (label) INN (LAMIVUDINE ; TENOFOVIR DISOPROXIL FUMARATE) LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2018 DISCONTINUED
NDA 091215 (pdf not found) INN (EFAVIRENZ ; EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2018
NDA 022343 (label) INN (EFAVIRENZ ; LAMIVUDINE ; TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2018 DISCONTINUED
NDA 203041 (pdf not found) INN (EFAVIRENZ ; EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2018
NDA 203232 (pdf not found) INN (TENOFOVIR DISOPROXIL FUMARATE) TENOFOVIR DISOPROXIL FUMARATE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2018
NDA 206569 (pdf not found) INN (TENOFOVIR DISOPROXIL FUMARATE) TENOFOVIR DISOPROXIL FUMARATE (NORVIUM BIOSCIENCE) APPROVAL= AP YEAR= 2018 DISCONTINUED
NDA 208255 (label) INN (EFAVIRENZ ; LAMIVUDINE ; TENOFOVIR DISOPROXIL FUMARATE) SYMFI LO (MYLAN) APPROVAL= AP YEAR= 2018
NDA 206436 (pdf not found) INN (EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (NORVIUM BIOSCIENCE) APPROVAL= AP YEAR= 2018
NDA 209498 (pdf not found) INN (TENOFOVIR DISOPROXIL FUMARATE) TENOFOVIR DISOPROXIL FUMARATE (QILU) APPROVAL= AP YEAR= 2018
NDA 209550 (label) INN (TENOFOVIR DISOPROXIL FUMARATE) TENOFOVIR DISOPROXIL FUMARATE (CHARTWELL RX) APPROVAL= AP YEAR= 2018 DISCONTINUED
NDA 206481 (pdf not found) INN (TENOFOVIR DISOPROXIL FUMARATE) TENOFOVIR DISOPROXIL FUMARATE (CHARTWELL) APPROVAL= AP YEAR= 2018
NDA 209721 (pdf not found) INN (EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (AMNEAL PHARMS CO) APPROVAL= AP YEAR= 2018
NDA 210807 (label) INN (DORAVIRINE ; LAMIVUDINE ; TENOFOVIR DISOPROXIL FUMARATE) DELSTRIGO (MSD MERCK CO) APPROVAL= AP YEAR= 2018
NDA 211284 (label) INN (LAMIVUDINE ; TENOFOVIR DISOPROXIL FUMARATE) TEMIXYS (CHARTWELL RX) APPROVAL= AP YEAR= 2018 DISCONTINUED
NDA 206894 (pdf not found) INN (EFAVIRENZ ; EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE (CIPLA) APPROVAL= AP YEAR= 2019
NDA 210649 (label) INN (EFAVIRENZ ; LAMIVUDINE ; TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2019 DISCONTINUED
NDA 210787 (pdf not found) INN (DOLUTEGRAVIR ; LAMIVUDINE ; TENOFOVIR DISOPROXIL FUMARATE) DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE (LAURUS LABS LTD) APPROVAL= TA YEAR= 2019
NDA 212114 (pdf not found) INN (EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (LAURUS) APPROVAL= AP YEAR= 2019
NDA 210796 (pdf not found) INN (DOLUTEGRAVIR ; LAMIVUDINE ; TENOFOVIR DISOPROXIL FUMARATE) DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE (MACLEODS PHARMS LTD) APPROVAL= TA YEAR= 2019
NDA 203442 (pdf not found) INN (EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2020
NDA 212689 (pdf not found) INN (EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2020
NDA 212786 (pdf not found) INN (EFAVIRENZ ; LAMIVUDINE ; TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE (LAURUS) APPROVAL= AP YEAR= 2020
NDA 213038 (pdf not found) INN (EFAVIRENZ ; LAMIVUDINE ; TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE (LAURUS) APPROVAL= AP YEAR= 2020
NDA 213556 (pdf not found) INN (DOLUTEGRAVIR ; LAMIVUDINE ; TENOFOVIR DISOPROXIL FUMARATE) DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE (SHANGHAI DESANA BIO-PHARMACEUTICALS CO LTD) APPROVAL= TA YEAR= 2020
NDA 201806 (pdf not found) INN (EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2021
NDA 091055 (pdf not found) INN (EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (STRIDES PHARMA) APPROVAL= AP YEAR= 2021
NDA 090958 (pdf not found) INN (EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (CIPLA) APPROVAL= AP YEAR= 2021 DISCONTINUED
NDA 204287 (pdf not found) INN (EFAVIRENZ ; EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2021
NDA 204131 (pdf not found) INN (EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (CHARTWELL RX) APPROVAL= AP YEAR= 2021
NDA 208740 (pdf not found) INN (EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (APOTEX) APPROVAL= AP YEAR= 2021 DISCONTINUED
NDA 212303 (pdf not found) INN (DOLUTEGRAVIR ; LAMIVUDINE ; TENOFOVIR DISOPROXIL FUMARATE) DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE (LUPIN PHARMS) APPROVAL= TA YEAR= 2021
NDA 213541 (pdf not found) INN (EFAVIRENZ ; EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE (LAURUS) APPROVAL= AP YEAR= 2021
NDA 203053 (pdf not found) INN (EFAVIRENZ ; EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE (HETERO LABS LTD V) APPROVAL= AP YEAR= 2022
NDA 211337 (pdf not found) INN (TENOFOVIR DISOPROXIL FUMARATE) TENOFOVIR DISOPROXIL FUMARATE (REYOUNG) APPROVAL= AP YEAR= 2023
NDA 211640 (pdf not found) INN (EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2023
NDA 201802 (pdf not found) INN (EFAVIRENZ ; EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ; EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (STRIDES PHARMA) APPROVAL= AP YEAR= 2023
NDA 211868 (pdf not found) INN (DOLUTEGRAVIR ; LAMIVUDINE ; TENOFOVIR DISOPROXIL FUMARATE) DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE (EMCURE PHARMS LTD) APPROVAL= TA YEAR= 2023
NDA 217016 (pdf not found) INN (DOLUTEGRAVIR ; TENOFOVIR DISOPROXIL FUMARATE ; LAMIVUDINE) DOLUTEGRAVIR; TENOFOVIR DISOPROXIL FUMARATE; LAMIVUDINE (STRIDES PHARMA) APPROVAL= TA YEAR= 2023
NDA 079071 (pdf not found) INN (TENOFOVIR DISOPROXIL FUMARATE) TENOFOVIR DISOPROXIL FUMARATE (NORVIUM BIOSCIENCE) APPROVAL= AP YEAR= 2024
NDA 209061 (pdf not found) INN (EFAVIRENZ ; EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE (MYLAN) APPROVAL= AP YEAR= 2024 DISCONTINUED
NDA 208452 (pdf not found) INN (EMTRICITABINE ; RILPIVIRINE HYDROCHLORIDE ; TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE (MYLAN) APPROVAL= AP YEAR= 2025
NDA 021356 (label) INN (TENOFOVIR DISOPROXIL FUMARATE) VIREAD (GILEAD SCIENCES INC) APPROVAL= AP YEAR= 2001 NEWMOLECULARENTITY
NDA 021752 (label) INN (EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE) TRUVADA (GILEAD) APPROVAL= AP YEAR= 2004
NDA 021937 (label) INN (EFAVIRENZ ; EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE) ATRIPLA (GILEAD SCIENCES) APPROVAL= AP YEAR= 2006
NDA 090049 (pdf not found) INN (EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE (MATRIX LABS LTD) APPROVAL= TA YEAR= 2009
NDA 090437 (pdf not found) INN (EFAVIRENZ ; EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE (MATRIX LABS LTD) APPROVAL= TA YEAR= 2009
NDA 022459 (pdf not found) INN (LAMIVUDINE ; TENOFOVIR DISOPROXIL FUMARATE) LAMIVUDINE/TENOFOVIR DISOPROXIL FUMARATE FDC TABS (HETERO DRUGS LTD) APPROVAL= TA YEAR= 2009
NDA 200623 (pdf not found) INN (LAMIVUDINE ; TENOFOVIR DISOPROXIL FUMARATE) LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE (CIPLA LIMITED) APPROVAL= TA YEAR= 2011
NDA 202123 (label) INN (EMTRICITABINE ; RILPIVIRINE HYDROCHLORIDE ; TENOFOVIR DISOPROXIL FUMARATE) COMPLERA (GILEAD SCIENCES INC) APPROVAL= AP YEAR= 2011
NDA 202171 (pdf not found) INN (LAMIVUDINE ; TENOFOVIR DISOPROXIL FUMARATE ; NEVIRAPINE) LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE; NEVIRAPINE (MATRIX LABS LTD) APPROVAL= TA YEAR= 2011
NDA 022577 (label) INN (TENOFOVIR DISOPROXIL FUMARATE) VIREAD (GILEAD SCIENCES INC) APPROVAL= AP YEAR= 2012
NDA 091593 (pdf not found) INN (EFAVIRENZ ; EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE (CIPLA LIMITED) APPROVAL= TA YEAR= 2012
NDA 203100 (label) INN (COBICISTAT ; ELVITEGRAVIR ; EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE) STRIBILD (GILEAD SCIENCES INC) APPROVAL= AP YEAR= 2012
NDA 203283 (pdf not found) INN (LAMIVUDINE ; TENOFOVIR DISOPROXIL FUMARATE) LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE (MACLEODS PHARMS LTD) APPROVAL= TA YEAR= 2012
NDA 202529 (pdf not found) INN (LAMIVUDINE ; TENOFOVIR DISOPROXIL FUMARATE) LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE (RANBAXY LABS LTD) APPROVAL= TA YEAR= 2013
NDA 204505 (pdf not found) INN (LAMIVUDINE ; TENOFOVIR DISOPROXIL FUMARATE ; NEVIRAPINE) LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE; NEVIRAPINE (AUROBINDO PHARMA LTD) APPROVAL= TA YEAR= 2013
NDA 204568 (pdf not found) INN (EFAVIRENZ ; LAMIVUDINE ; TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE (CIPLA) APPROVAL= TA YEAR= 2013
NDA 205355 (pdf not found) INN (LAMIVUDINE ; TENOFOVIR DISOPROXIL FUMARATE ; NEVIRAPINE) LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE; NEVIRAPINE (HETERO LABS LTD III) APPROVAL= TA YEAR= 2014
NDA 205861 (pdf not found) INN (EFAVIRENZ ; LAMIVUDINE ; TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE (MACLEODS PHARMS LTD) APPROVAL= TA YEAR= 2014
NDA 206042 (pdf not found) INN (EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE ; NEVIRAPINE) EMTRICITABINE;TENOFOVIR DISOPROXIL FUMARATE;NEVIRAPINE (MYLAN LABS LTD) APPROVAL= TA YEAR= 2014
NDA 091612 (pdf not found) INN (TENOFOVIR DISOPROXIL FUMARATE) TENOFOVIR DISOPROXIL FUMARATE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2015
NDA 204402 (pdf not found) INN (TENOFOVIR DISOPROXIL FUMARATE) TENOFOVIR DISOPROXIL FUMARATE (LUPIN LTD) APPROVAL= TA YEAR= 2015
NDA 206584 (pdf not found) INN (TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE (EMCURE PHARMS LTD) APPROVAL= TA YEAR= 2015 OBSOLETE
NDA 090742 (pdf not found) INN (TENOFOVIR DISOPROXIL FUMARATE) TENOFOVIR DISOPROXIL FUMARATE (STRIDES PHARMA) APPROVAL= AP YEAR= 2016
NDA 203470 (pdf not found) INN (TENOFOVIR DISOPROXIL FUMARATE) TENOFOVIR DISOPROXIL FUMARATE (PHARMACARE LTD) APPROVAL= TA YEAR= 2016 OBSOLETE
NDA 090894 (pdf not found) INN (EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2017
NDA 204119 (pdf not found) INN (EFAVIRENZ ; LAMIVUDINE ; TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE (HETERO DRUGS LTD) APPROVAL= TA YEAR= 2017
NDA 207315 (pdf not found) INN (LAMIVUDINE ; TENOFOVIR DISOPROXIL FUMARATE) LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE (HETERO LABS LTD III) APPROVAL= TA YEAR= 2017
NDA 209670 (pdf not found) INN (DOLUTEGRAVIR ; LAMIVUDINE ; TENOFOVIR DISOPROXIL FUMARATE) DOLUTEGRAVIR, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE (MYLAN PHARMS INC) APPROVAL= TA YEAR= 2017
NDA 022141 (label) INN (LAMIVUDINE ; TENOFOVIR DISOPROXIL FUMARATE) CIMDUO (MYLAN LABS LTD) APPROVAL= AP YEAR= 2018
NDA 022142 (label) INN (EFAVIRENZ ; LAMIVUDINE ; TENOFOVIR DISOPROXIL FUMARATE) SYMFI (MYLAN LABS LTD) APPROVAL= AP YEAR= 2018
NDA 078800 (pdf not found) INN (TENOFOVIR DISOPROXIL FUMARATE) TENOFOVIR DISOPROXIL FUMARATE (CIPLA) APPROVAL= AP YEAR= 2018
NDA 090513 (pdf not found) INN (EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2018
NDA 090636 (pdf not found) INN (TENOFOVIR DISOPROXIL FUMARATE) TENOFOVIR DISOPROXIL FUMARATE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2018
NDA 090647 (pdf not found) INN (TENOFOVIR DISOPROXIL FUMARATE) TENOFOVIR DISOPROXIL FUMARATE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2018
NDA 022344 (label) INN (LAMIVUDINE ; TENOFOVIR DISOPROXIL FUMARATE) LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2018 DISCONTINUED
NDA 091215 (pdf not found) INN (EFAVIRENZ ; EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE (TEVA PHARMS USA) APPROVAL= AP YEAR= 2018
NDA 022343 (label) INN (EFAVIRENZ ; LAMIVUDINE ; TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2018 DISCONTINUED
NDA 203041 (pdf not found) INN (EFAVIRENZ ; EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE (AUROBINDO PHARMA) APPROVAL= AP YEAR= 2018
NDA 203232 (pdf not found) INN (TENOFOVIR DISOPROXIL FUMARATE) TENOFOVIR DISOPROXIL FUMARATE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2018
NDA 206569 (pdf not found) INN (TENOFOVIR DISOPROXIL FUMARATE) TENOFOVIR DISOPROXIL FUMARATE (NORVIUM BIOSCIENCE) APPROVAL= AP YEAR= 2018 DISCONTINUED
NDA 208255 (label) INN (EFAVIRENZ ; LAMIVUDINE ; TENOFOVIR DISOPROXIL FUMARATE) SYMFI LO (MYLAN) APPROVAL= AP YEAR= 2018
NDA 206436 (pdf not found) INN (EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (NORVIUM BIOSCIENCE) APPROVAL= AP YEAR= 2018
NDA 209498 (pdf not found) INN (TENOFOVIR DISOPROXIL FUMARATE) TENOFOVIR DISOPROXIL FUMARATE (QILU) APPROVAL= AP YEAR= 2018
NDA 209550 (label) INN (TENOFOVIR DISOPROXIL FUMARATE) TENOFOVIR DISOPROXIL FUMARATE (CHARTWELL RX) APPROVAL= AP YEAR= 2018 DISCONTINUED
NDA 206481 (pdf not found) INN (TENOFOVIR DISOPROXIL FUMARATE) TENOFOVIR DISOPROXIL FUMARATE (CHARTWELL) APPROVAL= AP YEAR= 2018
NDA 209721 (pdf not found) INN (EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (AMNEAL PHARMS CO) APPROVAL= AP YEAR= 2018
NDA 210807 (label) INN (DORAVIRINE ; LAMIVUDINE ; TENOFOVIR DISOPROXIL FUMARATE) DELSTRIGO (MSD MERCK CO) APPROVAL= AP YEAR= 2018
NDA 211284 (label) INN (LAMIVUDINE ; TENOFOVIR DISOPROXIL FUMARATE) TEMIXYS (CHARTWELL RX) APPROVAL= AP YEAR= 2018 DISCONTINUED
NDA 206894 (pdf not found) INN (EFAVIRENZ ; EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE (CIPLA) APPROVAL= AP YEAR= 2019
NDA 210649 (label) INN (EFAVIRENZ ; LAMIVUDINE ; TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2019 DISCONTINUED
NDA 210787 (pdf not found) INN (DOLUTEGRAVIR ; LAMIVUDINE ; TENOFOVIR DISOPROXIL FUMARATE) DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE (LAURUS LABS LTD) APPROVAL= TA YEAR= 2019
NDA 212114 (pdf not found) INN (EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (LAURUS) APPROVAL= AP YEAR= 2019
NDA 210796 (pdf not found) INN (DOLUTEGRAVIR ; LAMIVUDINE ; TENOFOVIR DISOPROXIL FUMARATE) DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE (MACLEODS PHARMS LTD) APPROVAL= TA YEAR= 2019
NDA 203442 (pdf not found) INN (EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2020
NDA 212689 (pdf not found) INN (EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (ZYDUS PHARMS) APPROVAL= AP YEAR= 2020
NDA 212786 (pdf not found) INN (EFAVIRENZ ; LAMIVUDINE ; TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE (LAURUS) APPROVAL= AP YEAR= 2020
NDA 213038 (pdf not found) INN (EFAVIRENZ ; LAMIVUDINE ; TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE (LAURUS) APPROVAL= AP YEAR= 2020
NDA 213556 (pdf not found) INN (DOLUTEGRAVIR ; LAMIVUDINE ; TENOFOVIR DISOPROXIL FUMARATE) DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE (SHANGHAI DESANA BIO-PHARMACEUTICALS CO LTD) APPROVAL= TA YEAR= 2020
NDA 201806 (pdf not found) INN (EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (HETERO LABS LTD III) APPROVAL= AP YEAR= 2021
NDA 091055 (pdf not found) INN (EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (STRIDES PHARMA) APPROVAL= AP YEAR= 2021
NDA 090958 (pdf not found) INN (EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (CIPLA) APPROVAL= AP YEAR= 2021 DISCONTINUED
NDA 204287 (pdf not found) INN (EFAVIRENZ ; EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2021
NDA 204131 (pdf not found) INN (EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (CHARTWELL RX) APPROVAL= AP YEAR= 2021
NDA 208740 (pdf not found) INN (EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (APOTEX) APPROVAL= AP YEAR= 2021 DISCONTINUED
NDA 212303 (pdf not found) INN (DOLUTEGRAVIR ; LAMIVUDINE ; TENOFOVIR DISOPROXIL FUMARATE) DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE (LUPIN PHARMS) APPROVAL= TA YEAR= 2021
NDA 213541 (pdf not found) INN (EFAVIRENZ ; EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE (LAURUS) APPROVAL= AP YEAR= 2021
NDA 203053 (pdf not found) INN (EFAVIRENZ ; EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE (HETERO LABS LTD V) APPROVAL= AP YEAR= 2022
NDA 211337 (pdf not found) INN (TENOFOVIR DISOPROXIL FUMARATE) TENOFOVIR DISOPROXIL FUMARATE (REYOUNG) APPROVAL= AP YEAR= 2023
NDA 211640 (pdf not found) INN (EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2023
NDA 201802 (pdf not found) INN (EFAVIRENZ ; EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ; EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE (STRIDES PHARMA) APPROVAL= AP YEAR= 2023
NDA 211868 (pdf not found) INN (DOLUTEGRAVIR ; LAMIVUDINE ; TENOFOVIR DISOPROXIL FUMARATE) DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE (EMCURE PHARMS LTD) APPROVAL= TA YEAR= 2023
NDA 217016 (pdf not found) INN (DOLUTEGRAVIR ; TENOFOVIR DISOPROXIL FUMARATE ; LAMIVUDINE) DOLUTEGRAVIR; TENOFOVIR DISOPROXIL FUMARATE; LAMIVUDINE (STRIDES PHARMA) APPROVAL= TA YEAR= 2023
NDA 079071 (pdf not found) INN (TENOFOVIR DISOPROXIL FUMARATE) TENOFOVIR DISOPROXIL FUMARATE (NORVIUM BIOSCIENCE) APPROVAL= AP YEAR= 2024
NDA 209061 (pdf not found) INN (EFAVIRENZ ; EMTRICITABINE ; TENOFOVIR DISOPROXIL FUMARATE) EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE (MYLAN) APPROVAL= AP YEAR= 2024 DISCONTINUED
NDA 208452 (pdf not found) INN (EMTRICITABINE ; RILPIVIRINE HYDROCHLORIDE ; TENOFOVIR DISOPROXIL FUMARATE) EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE (MYLAN) APPROVAL= AP YEAR= 2025