药品注册申请号:018057
申请类型:NDA (新药申请)
申请人:HQ SPCLT PHARMA
申请人全名:HQ SPECIALTY PHARMA 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
001 PLATINOL CISPLATIN INJECTABLE;INJECTION 10MG/VIAL Yes No None 1978/12/19 Approved Prior to Jan 1, 1982 Discontinued
002 CISPLATIN CISPLATIN INJECTABLE;INJECTION 50MG/VIAL Yes Yes None Approved Prior to Jan 1, 1982 Prescription
003 PLATINOL-AQ CISPLATIN INJECTABLE;INJECTION 0.5MG/ML Yes No None 1984/07/18 Discontinued
004 CISPLATIN CISPLATIN INJECTABLE;INJECTION 1MG/ML Yes No AP 1988/11/08 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
2022/03/24 SUPPL-92(补充) Approval Labeling STANDARD
2019/02/22 SUPPL-89(补充) Approval Manufacturing (CMC) N/A
2017/01/19 SUPPL-86(补充) Approval Manufacturing (CMC) STANDARD
2015/10/06 SUPPL-85(补充) Approval Manufacturing (CMC) STANDARD
2015/03/03 SUPPL-84(补充) Approval Manufacturing (CMC) STANDARD
2015/02/26 SUPPL-83(补充) Approval Labeling STANDARD
2014/02/06 SUPPL-82(补充) Approval Manufacturing (CMC) STANDARD
2011/12/29 SUPPL-81(补充) Approval Labeling 901 REQUIRED
2011/08/26 SUPPL-80(补充) Approval Labeling UNKNOWN
2010/09/02 SUPPL-79(补充) Approval Labeling STANDARD
2002/11/08 SUPPL-76(补充) Approval Labeling STANDARD
2001/01/16 SUPPL-75(补充) Approval Manufacturing (CMC) STANDARD
2000/09/13 SUPPL-74(补充) Approval Manufacturing (CMC) STANDARD
1999/05/05 SUPPL-72(补充) Approval Labeling STANDARD
1996/04/18 SUPPL-66(补充) Approval Manufacturing (CMC) STANDARD
1995/12/13 SUPPL-63(补充) Approval Manufacturing (CMC) STANDARD
1995/12/04 SUPPL-64(补充) Approval Manufacturing (CMC) STANDARD
1995/08/09 SUPPL-65(补充) Approval Labeling STANDARD
1993/05/17 SUPPL-62(补充) Approval Labeling STANDARD
1993/04/22 SUPPL-61(补充) Approval Efficacy UNKNOWN
1993/03/25 SUPPL-60(补充) Approval Labeling STANDARD
1992/07/27 SUPPL-56(补充) Approval Labeling
1991/11/27 SUPPL-53(补充) Approval Manufacturing (CMC) STANDARD
1991/11/01 SUPPL-59(补充) Approval Manufacturing (CMC) STANDARD
1991/07/11 SUPPL-57(补充) Approval Manufacturing (CMC) STANDARD
1990/12/11 SUPPL-51(补充) Approval Labeling
1990/09/27 SUPPL-55(补充) Approval Manufacturing (CMC) STANDARD
1990/05/29 SUPPL-58(补充) Approval Manufacturing (CMC) STANDARD
1990/04/04 SUPPL-52(补充) Approval Manufacturing (CMC) STANDARD
1989/03/02 SUPPL-49(补充) Approval Labeling
1988/11/08 SUPPL-47(补充) Approval Manufacturing (CMC) STANDARD
1988/05/05 SUPPL-44(补充) Approval Manufacturing (CMC) STANDARD
1988/02/11 SUPPL-27(补充) Approval Manufacturing (CMC) STANDARD
1988/01/13 SUPPL-45(补充) Approval Manufacturing (CMC) STANDARD
1988/01/12 SUPPL-50(补充) Approval Manufacturing (CMC) STANDARD
1987/06/08 SUPPL-40(补充) Approval Manufacturing (CMC) STANDARD
1987/04/10 SUPPL-46(补充) Approval Labeling
1987/03/23 SUPPL-43(补充) Approval Labeling
1987/03/05 SUPPL-35(补充) Approval Manufacturing (CMC) STANDARD
1986/11/06 SUPPL-42(补充) Approval Labeling
1986/08/26 SUPPL-39(补充) Approval Labeling
1986/08/19 SUPPL-41(补充) Approval Labeling
1986/05/02 SUPPL-21(补充) Approval Manufacturing (CMC) STANDARD
1986/01/22 SUPPL-38(补充) Approval Labeling
1985/09/16 SUPPL-33(补充) Approval Manufacturing (CMC) STANDARD
1985/08/23 SUPPL-22(补充) Approval Labeling
1985/07/03 SUPPL-32(补充) Approval Labeling
1985/03/05 SUPPL-29(补充) Approval Manufacturing (CMC) STANDARD
1985/03/05 SUPPL-28(补充) Approval Manufacturing (CMC) STANDARD
1984/07/18 SUPPL-23(补充) Approval Manufacturing (CMC) STANDARD
1984/04/04 SUPPL-24(补充) Approval Manufacturing (CMC) STANDARD
1984/02/27 SUPPL-20(补充) Approval Labeling
1983/10/31 SUPPL-26(补充) Approval Labeling
1983/01/13 SUPPL-19(补充) Approval Manufacturing (CMC) STANDARD
1982/06/10 SUPPL-17(补充) Approval Manufacturing (CMC) STANDARD
1981/12/29 SUPPL-12(补充) Approval Efficacy
1981/03/12 SUPPL-11(补充) Approval Labeling
1981/01/22 SUPPL-7(补充) Approval Manufacturing (CMC) STANDARD
1980/09/16 SUPPL-9(补充) Approval Labeling
1980/07/04 SUPPL-10(补充) Approval Manufacturing (CMC) STANDARD
1980/02/26 SUPPL-6(补充) Approval Labeling
1980/01/31 SUPPL-5(补充) Approval Labeling
1980/01/31 SUPPL-4(补充) Approval Manufacturing (CMC) STANDARD
1979/12/18 SUPPL-2(补充) Approval Labeling
1979/12/05 SUPPL-3(补充) Approval Manufacturing (CMC) STANDARD
1979/09/11 SUPPL-1(补充) Approval Manufacturing (CMC) STANDARD
1978/12/19 ORIG-1(原始申请) Approval Type 1 - New Molecular Entity STANDARD
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:CISPLATIN 剂型/给药途径:INJECTABLE;INJECTION 规格:1MG/ML 治疗等效代码:AP
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
018057 004 NDA CISPLATIN CISPLATIN INJECTABLE;INJECTION 1MG/ML Prescription Yes No AP 1988/11/08 HQ SPCLT PHARMA
074735 001 ANDA CISPLATIN CISPLATIN INJECTABLE;INJECTION 1MG/ML Prescription No Yes AP 1999/07/16 FRESENIUS KABI USA
074656 001 ANDA CISPLATIN CISPLATIN INJECTABLE;INJECTION 1MG/ML Prescription No No AP 2000/05/16 PHARMACHEMIE BV
075036 001 ANDA CISPLATIN CISPLATIN INJECTABLE;INJECTION 1MG/ML Prescription No No AP 2000/11/07 HIKMA
206774 001 ANDA CISPLATIN CISPLATIN INJECTABLE;INJECTION 1MG/ML Prescription No No AP 2015/08/18 ACCORD HLTHCARE
207323 001 ANDA CISPLATIN CISPLATIN INJECTABLE;INJECTION 1MG/ML Prescription No No AP 2017/03/17 GLAND PHARMA LTD
218868 001 ANDA CISPLATIN CISPLATIN INJECTABLE;INJECTION 1MG/ML Prescription No No AP 2024/05/10 QILU
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