美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=EFAVIRENZ"
商品名 申请号 产品号 申请类型 活性成分 剂型/给药途径 规格/剂量 RLD RS 申请号原始批准/暂定批准日期 产品号批准日期 申请人 市场状态
EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE 205861 001 NDA EFAVIRENZ;LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 600MG;300MG;300MG No No 2014/08/14 (TA) -- MACLEODS PHARMS LTD None (Tentative Approval)
LAMIVUDINE; ZIDOVUDINE; EFAVIRENZ 206040 001 NDA LAMIVUDINE;ZIDOVUDINE;EFAVIRENZ TABLET;ORAL 150MG;300MG;600MG No No 2014/09/04 (TA) -- MYLAN LABS LTD None (Tentative Approval)
EFAVIRENZ 091175 001 ANDA EFAVIRENZ TABLET;ORAL 600MG No No 2015/11/23 (TA) -- TEVA PHARMS USA None (Tentative Approval)
EFAVIRENZ 091471 001 ANDA EFAVIRENZ TABLET;ORAL 600MG No No 2016/02/17 2016/02/17 MYLAN Discontinued
EFAVIRENZ 207895 001 ANDA EFAVIRENZ TABLET;ORAL 600MG No No 2017/05/19 (TA) -- PHARMACARE LTD None (Tentative Approval)
EFAVIRENZ, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE 204119 001 NDA EFAVIRENZ;LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE TABLET; ORAL 600MG;300MG;300MG No No 2017/06/30 (TA) -- HETERO DRUGS LTD None (Tentative Approval)
EFAVIRENZ 078064 001 ANDA EFAVIRENZ CAPSULE;ORAL 50MG No No 2017/12/15 2017/12/15 AUROBINDO PHARMA Prescription
EFAVIRENZ 078064 002 ANDA EFAVIRENZ CAPSULE;ORAL 100MG No No 2017/12/15 2017/12/15 AUROBINDO PHARMA Prescription
EFAVIRENZ 078064 003 ANDA EFAVIRENZ CAPSULE;ORAL 200MG No Yes 2017/12/15 2017/12/15 AUROBINDO PHARMA Prescription
EFAVIRENZ 205389 001 NDA EFAVIRENZ TABLET;ORAL 50MG No No 2018/02/23 (TA) -- MICRO LABS LTD INDIA None (Tentative Approval)
EFAVIRENZ 205389 002 NDA EFAVIRENZ TABLET;ORAL 100MG No No 2018/02/23 (TA) -- MICRO LABS LTD INDIA None (Tentative Approval)
EFAVIRENZ 205389 003 NDA EFAVIRENZ TABLET;ORAL 200MG No No 2018/02/23 (TA) -- MICRO LABS LTD INDIA None (Tentative Approval)
EFAVIRENZ 204869 001 ANDA EFAVIRENZ TABLET;ORAL 600MG No No 2018/03/12 2018/03/12 STRIDES PHARMA Prescription
EFAVIRENZ 078886 001 ANDA EFAVIRENZ TABLET;ORAL 600MG No Yes 2018/04/27 2018/04/27 HETERO LABS LTD III Prescription
EFAVIRENZ 204766 001 ANDA EFAVIRENZ TABLET;ORAL 600MG No No 2018/06/15 2018/06/15 CIPLA Prescription
EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE 022343 001 NDA EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 600MG;300MG;300MG Yes No 2018/08/15 2018/08/15 AUROBINDO PHARMA LTD Discontinued
EFAVIRENZ 205322 001 ANDA EFAVIRENZ TABLET;ORAL 600MG No No 2018/08/30 2018/08/30 AUROBINDO PHARMA Discontinued
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE 203041 001 ANDA EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 600MG;200MG;300MG No No 2018/09/04 2018/09/04 AUROBINDO PHARMA Prescription
EFAVIRENZ 077673 001 ANDA EFAVIRENZ TABLET;ORAL 600MG No No 2018/09/21 2018/09/21 AUROBINDO PHARMA LTD Prescription
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE 091215 001 ANDA EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 600MG;200MG;300MG No No 2018/11/09 2018/11/09 TEVA PHARMS USA Prescription
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