METRONIDAZOLE甲硝唑_FDA数据库

申请号	产品号	商品名	活性成分	活性成分	剂型/给药途径	规格/剂量	申请机构	批准时间	参比制剂	标准制剂	市场状态	TE
(NDA) 216755	001	LIKMEZP	METRONIDAZOLE	甲硝唑	SUSPENSION;ORAL	500MG/5ML	SAPTALIS PHARMS	2023-09-22	Yes	Yes	RX
(NDA) 205223	001	NUVESSAP	METRONIDAZOLE	甲硝唑	GEL;VAGINAL	1.3%	CHEMO RESEARCH SL	2014-03-24	Yes	Yes	RX
(NDA) 021789	001	METROGEL	METRONIDAZOLE	甲硝唑	GEL;TOPICAL	1%	GALDERMA LABS LP	2005-06-30	Yes	Yes	RX	AB
(NDA) 020901	001	METROLOTION	METRONIDAZOLE	甲硝唑	LOTION;TOPICAL	0.75%	GALDERMA LABS LP	1998-11-24	Yes	Yes	RX	AB
(NDA) 020868	001	FLAGYL ER	METRONIDAZOLE	甲硝唑	TABLET, EXTENDED RELEASE;ORAL	750MG	PFIZER	1997-11-26	Yes	No	DISCN
(NDA) 020743	001	NORITATE	METRONIDAZOLE	甲硝唑	CREAM;TOPICAL	1%	BAUSCH	1997-09-26	Yes	Yes	RX
(NDA) 020531	001	METROCREAM	METRONIDAZOLE	甲硝唑	CREAM;TOPICAL	0.75%	GALDERMA LABS LP	1995-09-20	Yes	Yes	RX	AB
(NDA) 020334	001	FLAGYL	METRONIDAZOLE	甲硝唑	CAPSULE;ORAL	375MG	PFIZER	1995-05-03	Yes	Yes	RX	AB
(NDA) 020208	001	METROGEL-VAGINAL	METRONIDAZOLE	甲硝唑	GEL;VAGINAL	0.75%	BAUSCH	1992-08-17	Yes	Yes	RX	AB
(NDA) 019737	001	METROGEL	METRONIDAZOLE	甲硝唑	GEL;TOPICAL	0.75%	GALDERMA LABS LP	1988-11-22	Yes	No	DISCN
(NDA) 018900	001	METRO I.V. IN PLASTIC CONTAINER	METRONIDAZOLE	甲硝唑	INJECTABLE;INJECTION	500MG/100ML	B BRAUN	1983-09-29	Yes	Yes	RX	AP
(NDA) 018890	002	METRONIDAZOLE IN PLASTIC CONTAINER	METRONIDAZOLE	甲硝唑	INJECTABLE;INJECTION	500MG/100ML	HOSPIRA	1983-11-18	Yes	Yes	RX	AP
(NDA) 018657	001	FLAGYL I.V. RTU IN PLASTIC CONTAINER	METRONIDAZOLE	甲硝唑	INJECTABLE;INJECTION	500MG/100ML	BAXTER HLTHCARE	1982-01-01	Yes	Yes	RX	AP
(NDA) 012623	001	FLAGYL	METRONIDAZOLE	甲硝唑	TABLET;ORAL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PFIZER	1982-01-01	Yes	No	DISCN
(NDA) 012623	003	FLAGYL	METRONIDAZOLE	甲硝唑	TABLET;ORAL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PFIZER	1982-01-01	Yes	No	DISCN

申请号	产品号	商品名	活性成分	活性成分	剂型/给药途径	规格/剂量	申请机构	批准时间	参比制剂	标准制剂	市场状态	TE
(NDA) 216755	001	LIKMEZP	METRONIDAZOLE	甲硝唑	SUSPENSION;ORAL	500MG/5ML	SAPTALIS PHARMS	2023-09-22	Yes	Yes	RX
(NDA) 205223	001	NUVESSAP	METRONIDAZOLE	甲硝唑	GEL;VAGINAL	1.3%	CHEMO RESEARCH SL	2014-03-24	Yes	Yes	RX
(NDA) 021789	001	METROGEL	METRONIDAZOLE	甲硝唑	GEL;TOPICAL	1%	GALDERMA LABS LP	2005-06-30	Yes	Yes	RX	AB
(NDA) 020901	001	METROLOTION	METRONIDAZOLE	甲硝唑	LOTION;TOPICAL	0.75%	GALDERMA LABS LP	1998-11-24	Yes	Yes	RX	AB
(NDA) 020868	001	FLAGYL ER	METRONIDAZOLE	甲硝唑	TABLET, EXTENDED RELEASE;ORAL	750MG	PFIZER	1997-11-26	Yes	No	DISCN
(NDA) 020743	001	NORITATE	METRONIDAZOLE	甲硝唑	CREAM;TOPICAL	1%	BAUSCH	1997-09-26	Yes	Yes	RX
(NDA) 020531	001	METROCREAM	METRONIDAZOLE	甲硝唑	CREAM;TOPICAL	0.75%	GALDERMA LABS LP	1995-09-20	Yes	Yes	RX	AB
(NDA) 020334	001	FLAGYL	METRONIDAZOLE	甲硝唑	CAPSULE;ORAL	375MG	PFIZER	1995-05-03	Yes	Yes	RX	AB
(NDA) 020208	001	METROGEL-VAGINAL	METRONIDAZOLE	甲硝唑	GEL;VAGINAL	0.75%	BAUSCH	1992-08-17	Yes	Yes	RX	AB
(NDA) 019737	001	METROGEL	METRONIDAZOLE	甲硝唑	GEL;TOPICAL	0.75%	GALDERMA LABS LP	1988-11-22	Yes	No	DISCN
(NDA) 018900	001	METRO I.V. IN PLASTIC CONTAINER	METRONIDAZOLE	甲硝唑	INJECTABLE;INJECTION	500MG/100ML	B BRAUN	1983-09-29	Yes	Yes	RX	AP
(NDA) 018890	002	METRONIDAZOLE IN PLASTIC CONTAINER	METRONIDAZOLE	甲硝唑	INJECTABLE;INJECTION	500MG/100ML	HOSPIRA	1983-11-18	Yes	Yes	RX	AP
(NDA) 018657	001	FLAGYL I.V. RTU IN PLASTIC CONTAINER	METRONIDAZOLE	甲硝唑	INJECTABLE;INJECTION	500MG/100ML	BAXTER HLTHCARE	1982-01-01	Yes	Yes	RX	AP
(NDA) 012623	001	FLAGYL	METRONIDAZOLE	甲硝唑	TABLET;ORAL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PFIZER	1982-01-01	Yes	No	DISCN
(NDA) 012623	003	FLAGYL	METRONIDAZOLE	甲硝唑	TABLET;ORAL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PFIZER	1982-01-01	Yes	No	DISCN