美国FDA药品数据库-药物在线

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	077916	001	ANDA	EFAVIRENZ	TABLET; ORAL	600MG	No	No	2006/05/24 (TA)	--	CIPLA LIMITED	None (Tentative Approval)
LAMIVUDINE; ZIDOVUDINE; EFAVIRENZ	022096	001	NDA	LAMIVUDINE; ZIDOVUDINE; EFAVIRENZ	TABLET; ORAL	150MG; 300MG; 600MG	No	No	2007/06/01 (TA)	--	STRIDES ACROLAB	None (Tentative Approval)
STAVUDINE; LAMIVUDINE; EFAVIRENZ	022097	001	NDA	STAVUDINE; LAMIVUDINE; EFAVIRENZ	TABLET; ORAL	40MG; 150MG; 600MG	No	No	2007/06/01 (TA)	--	STRIDES ACROLAB	None (Tentative Approval)
EFAVIRENZ	078958	001	ANDA	EFAVIRENZ	TABLET; ORAL	600MG	No	No	2007/12/20 (TA)	--	EMCURE PHARMA	None (Tentative Approval)
EFAVIRENZ	078883	001	ANDA	EFAVIRENZ	TABLET; ORAL	600MG	No	No	2008/04/25 (TA)	--	MATRIX LABS	None (Tentative Approval)
EFAVIRENZ	090155	001	ANDA	EFAVIRENZ	CAPSULE; ORAL	200MG	No	No	2009/08/03 (TA)	--	CIPLA LIMITED	None (Tentative Approval)
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	090437	001	ANDA	EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	TABLET; ORAL	600MG; 200MG; 300MG	No	No	2009/08/12 (TA)	--	MATRIX LABS LTD	None (Tentative Approval)
EFAVIRENZ	022461	001	NDA	EFAVIRENZ	TABLET; ORAL	50MG	No	No	2009/11/24 (TA)	--	MATRIX LABS LTD	None (Tentative Approval)
EFAVIRENZ	022461	002	NDA	EFAVIRENZ	TABLET; ORAL	100MG	No	No	2009/11/24 (TA)	--	MATRIX LABS LTD	None (Tentative Approval)
EFAVIRENZ	022461	003	NDA	EFAVIRENZ	TABLET; ORAL	200MG	No	No	2009/11/24 (TA)	--	MATRIX LABS LTD	None (Tentative Approval)
EFAVIRENZ 200MG SCORED TABLETS	022420	001	NDA	EFAVIRENZ	TABLET; ORAL	200MG	No	No	2010/02/12 (TA)	--	STRIDES ARCOLAB LTD	None (Tentative Approval)
EFAVIRENZ	091579	001	ANDA	EFAVIRENZ	TABLET; ORAL	600MG	No	No	2011/08/29 (TA)	--	MACLEODS PHARMS LTD	None (Tentative Approval)
EFAVIRENZ	202042	001	ANDA	EFAVIRENZ	CAPSULE; ORAL	50MG	No	No	2012/01/19 (TA)	--	MICRO LABS LTD	None (Tentative Approval)
EFAVIRENZ	202042	002	ANDA	EFAVIRENZ	CAPSULE; ORAL	200MG	No	No	2012/01/19 (TA)	--	MICRO LABS LTD	None (Tentative Approval)
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	091593	001	ANDA	EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	TABLET; ORAL	600MG	No	No	2012/02/27 (TA)	--	CIPLA LIMITED	None (Tentative Approval)
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	091593	002	ANDA	EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	TABLET; ORAL	200MG	No	No	2012/02/27 (TA)	--	CIPLA LIMITED	None (Tentative Approval)
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	091593	003	ANDA	EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	TABLET; ORAL	300MG	No	No	2012/02/27 (TA)	--	CIPLA LIMITED	None (Tentative Approval)
EFAVIRENZ	202301	001	ANDA	EFAVIRENZ	TABLET; ORAL	600MG	No	No	2012/06/20 (TA)	--	MICRO LABS LTD	None (Tentative Approval)
EFAVIRENZ	202990	001	ANDA	EFAVIRENZ	TABLET; ORAL	600MG	No	No	2012/06/25 (TA)	--	PAR FORMULATIONS PRIVATE LTD	None (Tentative Approval)
EFAVIRENZ, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE	204568	001	NDA	EFAVIRENZ;LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE	TABLET; ORAL	600MG	No	No	2013/12/30 (TA)	--	CIPLA	None (Tentative Approval)