药品注册申请号:071427
申请类型:ANDA (仿制药申请)
申请人:CHARTWELL RX
申请人全名:CHARTWELL RX SCIENCES LLC
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 TEMAZEPAM TEMAZEPAM CAPSULE;ORAL 15MG No No AB 1988/01/12 1988/01/12 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
2023/06/21 SUPPL-34(补充) Approval Labeling STANDARD
2021/05/21 SUPPL-32(补充) Approval Labeling STANDARD
2019/09/06 SUPPL-31(补充) Approval Labeling STANDARD
2019/09/06 SUPPL-30(补充) Approval Labeling STANDARD
2011/02/03 SUPPL-24(补充) Approval Labeling
2008/10/08 SUPPL-19(补充) Approval Labeling
2001/11/06 SUPPL-13(补充) Approval Manufacturing (CMC)
2001/08/08 SUPPL-12(补充) Approval Manufacturing (CMC)
2001/08/08 SUPPL-11(补充) Approval Manufacturing (CMC)
2000/11/30 SUPPL-10(补充) Approval Manufacturing (CMC)
1999/05/05 SUPPL-8(补充) Approval Manufacturing (CMC)
1995/03/02 SUPPL-6(补充) Approval Manufacturing (CMC)
1994/01/19 SUPPL-5(补充) Approval Labeling
1993/12/09 SUPPL-7(补充) Approval Manufacturing (CMC)
1991/09/09 SUPPL-3(补充) Approval Manufacturing (CMC)
1991/02/01 SUPPL-4(补充) Approval Labeling
1989/10/05 SUPPL-2(补充) Approval Labeling
1989/02/22 SUPPL-1(补充) Approval Manufacturing (CMC)
1988/01/12 ORIG-1(原始申请) Approval
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:TEMAZEPAM 剂型/给药途径:CAPSULE;ORAL 规格:15MG 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
018163 001 NDA RESTORIL TEMAZEPAM CAPSULE;ORAL 15MG Prescription Yes No AB Approved Prior to Jan 1, 1982 SPECGX LLC
071456 001 ANDA TEMAZEPAM TEMAZEPAM CAPSULE;ORAL 15MG Prescription No No AB 1987/04/21 NOVEL LABS INC
071620 002 ANDA TEMAZEPAM TEMAZEPAM CAPSULE;ORAL 15MG Prescription No No AB 1987/08/07 ACTAVIS ELIZABETH
071427 001 ANDA TEMAZEPAM TEMAZEPAM CAPSULE;ORAL 15MG Prescription No No AB 1988/01/12 CHARTWELL RX
201781 002 ANDA TEMAZEPAM TEMAZEPAM CAPSULE;ORAL 15MG Prescription No No AB 2015/06/04 PRINSTON INC
203482 002 ANDA TEMAZEPAM TEMAZEPAM CAPSULE;ORAL 15MG Prescription No No AB 2016/05/23 AMNEAL PHARMS
211542 002 ANDA TEMAZEPAM TEMAZEPAM CAPSULE;ORAL 15MG Prescription No No AB 2018/11/23 ALEMBIC
217875 002 ANDA TEMAZEPAM TEMAZEPAM CAPSULE;ORAL 15MG Prescription No No AB 2023/08/24 ALKEM LABS LTD
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药品NDC数据与药品包装、标签说明书
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