药品注册申请号:017892
申请类型:NDA (新药申请)
申请人:PFIZER
申请人全名:PFIZER INC
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
001 HALCION TRIAZOLAM TABLET;ORAL 0.25MG Yes Yes AB 1982/11/15 1982/11/15 Prescription
002 HALCION TRIAZOLAM TABLET;ORAL 0.5MG No No None 1982/11/15 Discontinued
003 HALCION TRIAZOLAM TABLET;ORAL 0.125MG Yes No AB 1985/04/26 Prescription
批准日期,申请提交历史,通知信,药品说明书,审评文件等信息
提交状态日期提交号审批结论申请内容分类审评优先级;罕用药状态通知信、审评文件、说明书、包装标签备注
2023/01/13 SUPPL-57(补充) Approval Labeling STANDARD
2021/10/27 SUPPL-56(补充) Approval Labeling STANDARD
2021/02/05 SUPPL-55(补充) Approval Labeling 901 REQUIRED
2019/10/09 SUPPL-50(补充) Approval Labeling STANDARD
2019/02/06 SUPPL-54(补充) Approval Labeling 901 REQUIRED
2016/12/16 SUPPL-49(补充) Approval Labeling 901 REQUIRED
2015/12/15 SUPPL-48(补充) Approval Manufacturing (CMC) PRIORITY
2014/09/18 SUPPL-47(补充) Approval Labeling STANDARD
2014/01/21 SUPPL-45(补充) Approval Manufacturing (CMC) PRIORITY
2013/01/25 SUPPL-44(补充) Approval Manufacturing (CMC) PRIORITY
2008/02/12 SUPPL-38(补充) Approval Labeling STANDARD
2003/06/25 SUPPL-34(补充) Approval Labeling STANDARD
1999/11/04 SUPPL-35(补充) Approval Manufacturing (CMC) PRIORITY
1996/04/04 SUPPL-33(补充) Approval Labeling STANDARD
1994/11/04 SUPPL-32(补充) Approval Manufacturing (CMC) PRIORITY
1994/07/13 SUPPL-31(补充) Approval Manufacturing (CMC) PRIORITY
1993/09/14 SUPPL-30(补充) Approval Labeling STANDARD
1993/05/25 SUPPL-26(补充) Approval Manufacturing (CMC) PRIORITY
1993/05/21 SUPPL-21(补充) Approval Manufacturing (CMC) PRIORITY
1992/02/21 SUPPL-24(补充) Approval Manufacturing (CMC) PRIORITY
1991/11/13 SUPPL-23(补充) Approval Labeling
1991/01/17 SUPPL-22(补充) Approval Labeling
1990/08/16 SUPPL-19(补充) Approval Labeling
1990/08/16 SUPPL-18(补充) Approval Labeling
1990/08/16 SUPPL-17(补充) Approval Labeling
1989/03/20 SUPPL-16(补充) Approval Labeling
1988/08/24 SUPPL-9(补充) Approval Manufacturing (CMC) PRIORITY
1988/07/26 SUPPL-13(补充) Approval Manufacturing (CMC) PRIORITY
1988/05/06 SUPPL-15(补充) Approval Labeling
1988/05/05 SUPPL-14(补充) Approval Labeling
1988/03/25 SUPPL-12(补充) Approval Manufacturing (CMC) PRIORITY
1987/10/23 SUPPL-11(补充) Approval Labeling
1987/10/23 SUPPL-10(补充) Approval Labeling
1987/10/23 SUPPL-8(补充) Approval Labeling
1987/10/23 SUPPL-7(补充) Approval Labeling
1987/10/23 SUPPL-2(补充) Approval Labeling
1985/12/06 SUPPL-5(补充) Approval Manufacturing (CMC) PRIORITY
1985/04/26 SUPPL-4(补充) Approval Labeling
1985/04/26 SUPPL-1(补充) Approval Manufacturing (CMC) PRIORITY
1982/11/15 ORIG-1(原始申请) 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)
关联产品号专利号专利过期日是否物质专利是否产品专利专利用途代码撤销请求提交日期专利下载备注
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
活性成分:TRIAZOLAM 剂型/给药途径:TABLET;ORAL 规格:0.25MG 治疗等效代码:AB
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
017892 001 NDA HALCION TRIAZOLAM TABLET;ORAL 0.25MG Prescription Yes Yes AB 1982/11/15 PFIZER
074224 002 ANDA TRIAZOLAM TRIAZOLAM TABLET;ORAL 0.25MG Prescription No No AB 1994/06/01 HIKMA
214219 002 ANDA TRIAZOLAM TRIAZOLAM TABLET;ORAL 0.25MG Prescription No No AB 2020/10/20 NOVAST LABS
216890 002 ANDA TRIAZOLAM TRIAZOLAM TABLET;ORAL 0.25MG Prescription No No AB 2022/11/08 SANDOZ
213003 002 ANDA TRIAZOLAM TRIAZOLAM TABLET;ORAL 0.25MG Prescription No No AB 2022/12/28 ZYDUS PHARMS
活性成分:TRIAZOLAM 剂型/给药途径:TABLET;ORAL 规格:0.125MG 治疗等效代码:AB
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
017892 003 NDA HALCION TRIAZOLAM TABLET;ORAL 0.125MG Prescription Yes No AB 1985/04/26 PFIZER
074224 001 ANDA TRIAZOLAM TRIAZOLAM TABLET;ORAL 0.125MG Prescription No No AB 1994/06/01 HIKMA
214219 001 ANDA TRIAZOLAM TRIAZOLAM TABLET;ORAL 0.125MG Prescription No No AB 2020/10/20 NOVAST LABS
216890 001 ANDA TRIAZOLAM TRIAZOLAM TABLET;ORAL 0.125MG Prescription No No AB 2022/11/08 SANDOZ
213003 001 ANDA TRIAZOLAM TRIAZOLAM TABLET;ORAL 0.125MG Prescription No No AB 2022/12/28 ZYDUS PHARMS
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药品NDC数据与药品包装、标签说明书
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