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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 | AB |
(NDA) 050786 | 001 | PYLERA | BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE | 枸橼酸铋钾;甲硝唑;盐酸四环素 | CAPSULE;ORAL | 140MG;125MG;125MG | LABS JUVISE | 2006-09-28 | Yes | Yes | RX | AB |
(NDA) 050719 | 001 | HELIDAC | BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE | 碱式水杨酸铋;甲硝唑;盐酸四环素 | TABLET, CHEWABLE, TABLET, CAPSULE;ORAL | 262.4MG,N/A,N/A;N/A,250MG,N/A;N/A,N/A,500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CASPER PHARMA LLC | 1996-08-15 | Yes | No | DISCN | |
(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 |