药品注册申请号:011808
申请类型:NDA (新药申请)
申请人:NOVARTIS
申请人全名:NOVARTIS PHARMACEUTICALS CORP
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
003 MELLARIL THIORIDAZINE HYDROCHLORIDE TABLET;ORAL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1962/03/15 Approved Prior to Jan 1, 1982 Discontinued
006 MELLARIL THIORIDAZINE HYDROCHLORIDE TABLET;ORAL 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
009 MELLARIL THIORIDAZINE HYDROCHLORIDE TABLET;ORAL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
011 MELLARIL THIORIDAZINE HYDROCHLORIDE TABLET;ORAL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
012 MELLARIL THIORIDAZINE HYDROCHLORIDE CONCENTRATE;ORAL 30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No None Approved Prior to Jan 1, 1982 Discontinued
015 MELLARIL THIORIDAZINE HYDROCHLORIDE TABLET;ORAL 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
016 MELLARIL THIORIDAZINE HYDROCHLORIDE TABLET;ORAL 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
017 MELLARIL THIORIDAZINE HYDROCHLORIDE TABLET;ORAL 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
018 MELLARIL THIORIDAZINE HYDROCHLORIDE CONCENTRATE;ORAL 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No None Approved Prior to Jan 1, 1982 Discontinued
批准日期,审批历史,通知信,药品说明书,审评文件等信息
审批结论日期申请类型申请提交号审批结论申请内容分类审评分类(优先级;罕用药状态)通知信、审评文件、说明书、包装标签备注
2007/12/07 SUPPL 174 Approval Labeling STANDARD
2007/12/07 SUPPL 171 Approval Labeling STANDARD
2007/12/07 SUPPL 166 Approval Labeling STANDARD
2007/12/07 SUPPL 164 Approval Labeling STANDARD
2007/12/07 SUPPL 160 Approval Labeling STANDARD
2007/12/07 SUPPL 159 Approval Labeling STANDARD
2007/12/07 SUPPL 157 Approval Labeling
2007/12/07 SUPPL 154 Approval Labeling
2007/12/07 SUPPL 153 Approval Labeling
2007/12/07 SUPPL 152 Approval Labeling
2007/12/07 SUPPL 150 Approval Labeling
2007/12/07 SUPPL 148 Approval Labeling
2007/12/07 SUPPL 145 Approval Labeling
2007/12/07 SUPPL 139 Approval Labeling
2007/12/07 SUPPL 137 Approval Labeling
2007/12/07 SUPPL 136 Approval Labeling
2007/12/07 SUPPL 129 Approval Labeling
2007/12/07 SUPPL 128 Approval Labeling
2007/12/07 SUPPL 126 Approval Labeling
2007/12/07 SUPPL 118 Approval Labeling
2007/12/07 SUPPL 107 Approval Labeling
2007/12/07 SUPPL 106 Approval Labeling
2007/12/07 SUPPL 105 Approval Labeling
2007/12/07 SUPPL 101 Approval Labeling
2007/12/07 SUPPL 97 Approval Labeling
2007/12/07 SUPPL 96 Approval Labeling
2007/12/07 SUPPL 93 Approval Labeling
2007/12/07 SUPPL 85 Approval Labeling
2007/12/07 SUPPL 77 Approval Labeling
2007/12/07 SUPPL 68 Approval Labeling
2007/12/07 SUPPL 61 Approval Labeling
2007/12/07 SUPPL 59 Approval Labeling
2007/12/07 SUPPL 31 Approval Efficacy
2007/12/07 SUPPL 29 Approval Labeling
2007/12/07 SUPPL 28 Approval Labeling
2001/06/15 SUPPL 177 Approval Manufacturing (CMC) PRIORITY
2001/03/28 SUPPL 179 Approval Manufacturing (CMC) PRIORITY
2001/03/15 SUPPL 178 Approval Labeling STANDARD
2000/06/19 SUPPL 175 Approval Labeling STANDARD
2000/03/01 SUPPL 176 Approval Manufacturing (CMC) PRIORITY
1999/05/25 SUPPL 172 Approval Manufacturing (CMC) PRIORITY
1999/04/15 SUPPL 173 Approval Manufacturing (CMC) PRIORITY
1997/01/15 SUPPL 170 Approval Manufacturing (CMC) PRIORITY
1996/03/20 SUPPL 169 Approval Manufacturing (CMC) PRIORITY
1995/11/22 SUPPL 168 Approval Manufacturing (CMC) PRIORITY
1995/10/17 SUPPL 165 Approval Manufacturing (CMC) PRIORITY
1994/12/02 SUPPL 138 Approval Manufacturing (CMC) PRIORITY
1994/11/28 SUPPL 117 Approval Manufacturing (CMC) PRIORITY
1962/03/15 ORIG 1 Approval Type 1 - New Molecular Entity PRIORITY
与本品相关的专利信息(来自FDA橙皮书Orange Book)
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与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
与本品治疗等效的药品
本品无治疗等效药品
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