药品注册申请号：077244
申请类型：ANDA (仿制药申请)
申请人：HIKMA
申请人全名：HIKMA PHARMACEUTICALS USA 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 CARBOPLATIN CARBOPLATIN INJECTABLE;INTRAVENOUS 50MG/5ML (10MG/ML) No No AP 2004/10/15 2004/10/15 Prescription
002 CARBOPLATIN CARBOPLATIN INJECTABLE;INTRAVENOUS 150MG/15ML (10MG/ML) No No AP 2004/10/15 Prescription
003 CARBOPLATIN CARBOPLATIN INJECTABLE;INTRAVENOUS 450MG/45ML (10MG/ML) No No AP 2004/10/15 Prescription
004 CARBOPLATIN CARBOPLATIN INJECTABLE;INTRAVENOUS 600MG/60ML (10MG/ML) No No AP 2006/01/20 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
2012/03/13 SUPPL-10（补充） Approval Labeling
2011/09/07 SUPPL-8（补充） Approval Labeling
2006/01/20 SUPPL-3（补充） Approval Labeling
2006/01/20 SUPPL-2（补充） Approval Manufacturing (CMC)
2005/07/11 SUPPL-1（补充） Approval Labeling
2004/10/15 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
无
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
无
与本品治疗等效的药品
活性成分:CARBOPLATIN 剂型/给药途径:INJECTABLE;INTRAVENOUS 规格:50MG/5ML (10MG/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
076517 001 ANDA CARBOPLATIN CARBOPLATIN INJECTABLE;INTRAVENOUS 50MG/5ML (10MG/ML) Prescription No Yes AP 2004/10/14 HOSPIRA
077269 001 ANDA CARBOPLATIN CARBOPLATIN INJECTABLE;INTRAVENOUS 50MG/5ML (10MG/ML) Prescription No No AP 2004/10/14 PHARMACHEMIE BV
077244 001 ANDA CARBOPLATIN CARBOPLATIN INJECTABLE;INTRAVENOUS 50MG/5ML (10MG/ML) Prescription No No AP 2004/10/15 HIKMA
077861 001 ANDA CARBOPLATIN CARBOPLATIN INJECTABLE;INTRAVENOUS 50MG/5ML (10MG/ML) Prescription No No AP 2007/01/18 TEYRO LABS
078280 001 ANDA CARBOPLATIN CARBOPLATIN INJECTABLE;INTRAVENOUS 50MG/5ML (10MG/ML) Prescription No No AP 2008/05/08 SANDOZ
077926 001 ANDA CARBOPLATIN CARBOPLATIN INJECTABLE;INTRAVENOUS 50MG/5ML (10MG/ML) Prescription No No AP 2008/09/19 SUN PHARM
090475 001 ANDA CARBOPLATIN CARBOPLATIN INJECTABLE;INTRAVENOUS 50MG/5ML (10MG/ML) Prescription No No AP 2009/07/29 EPIC PHARMA LLC
205487 001 ANDA CARBOPLATIN CARBOPLATIN INJECTABLE;INTRAVENOUS 50MG/5ML (10MG/ML) Prescription No No AP 2016/03/28 EUGIA PHARMA
206775 001 ANDA CARBOPLATIN CARBOPLATIN INJECTABLE;INTRAVENOUS 50MG/5ML (10MG/ML) Prescription No No AP 2017/02/09 ACCORD HLTHCARE
207324 001 ANDA CARBOPLATIN CARBOPLATIN INJECTABLE;INTRAVENOUS 50MG/5ML (10MG/ML) Prescription No No AP 2017/02/15 GLAND PHARMA LTD
208487 001 ANDA CARBOPLATIN CARBOPLATIN INJECTABLE;INTRAVENOUS 50MG/5ML (10MG/ML) Prescription No No AP 2017/04/26 NOVAST LABS
活性成分:CARBOPLATIN 剂型/给药途径:INJECTABLE;INTRAVENOUS 规格:150MG/15ML (10MG/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
076517 002 ANDA CARBOPLATIN CARBOPLATIN INJECTABLE;INTRAVENOUS 150MG/15ML (10MG/ML) Prescription No Yes AP 2004/10/14 HOSPIRA
077269 002 ANDA CARBOPLATIN CARBOPLATIN INJECTABLE;INTRAVENOUS 150MG/15ML (10MG/ML) Prescription No No AP 2004/10/14 PHARMACHEMIE BV
077244 002 ANDA CARBOPLATIN CARBOPLATIN INJECTABLE;INTRAVENOUS 150MG/15ML (10MG/ML) Prescription No No AP 2004/10/15 HIKMA
077861 002 ANDA CARBOPLATIN CARBOPLATIN INJECTABLE;INTRAVENOUS 150MG/15ML (10MG/ML) Prescription No No AP 2007/01/18 TEYRO LABS
078280 002 ANDA CARBOPLATIN CARBOPLATIN INJECTABLE;INTRAVENOUS 150MG/15ML (10MG/ML) Prescription No No AP 2008/05/08 SANDOZ
077926 002 ANDA CARBOPLATIN CARBOPLATIN INJECTABLE;INTRAVENOUS 150MG/15ML (10MG/ML) Prescription No No AP 2008/09/19 SUN PHARM
090475 002 ANDA CARBOPLATIN CARBOPLATIN INJECTABLE;INTRAVENOUS 150MG/15ML (10MG/ML) Prescription No No AP 2009/07/29 EPIC PHARMA LLC
205487 002 ANDA CARBOPLATIN CARBOPLATIN INJECTABLE;INTRAVENOUS 150MG/15ML (10MG/ML) Prescription No No AP 2016/03/28 EUGIA PHARMA
206775 002 ANDA CARBOPLATIN CARBOPLATIN INJECTABLE;INTRAVENOUS 150MG/15ML (10MG/ML) Prescription No No AP 2017/02/09 ACCORD HLTHCARE
207324 002 ANDA CARBOPLATIN CARBOPLATIN INJECTABLE;INTRAVENOUS 150MG/15ML (10MG/ML) Prescription No No AP 2017/02/15 GLAND PHARMA LTD
208487 002 ANDA CARBOPLATIN CARBOPLATIN INJECTABLE;INTRAVENOUS 150MG/15ML (10MG/ML) Prescription No No AP 2017/04/26 NOVAST LABS
活性成分:CARBOPLATIN 剂型/给药途径:INJECTABLE;INTRAVENOUS 规格:450MG/45ML (10MG/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
076517 003 ANDA CARBOPLATIN CARBOPLATIN INJECTABLE;INTRAVENOUS 450MG/45ML (10MG/ML) Prescription No Yes AP 2004/10/14 HOSPIRA
077269 003 ANDA CARBOPLATIN CARBOPLATIN INJECTABLE;INTRAVENOUS 450MG/45ML (10MG/ML) Prescription No No AP 2004/10/14 PHARMACHEMIE BV
077244 003 ANDA CARBOPLATIN CARBOPLATIN INJECTABLE;INTRAVENOUS 450MG/45ML (10MG/ML) Prescription No No AP 2004/10/15 HIKMA
077247 003 ANDA CARBOPLATIN CARBOPLATIN INJECTABLE;INTRAVENOUS 450MG/45ML (10MG/ML) Prescription No No AP 2004/10/21 FRESENIUS KABI USA
077266 003 ANDA CARBOPLATIN CARBOPLATIN INJECTABLE;INTRAVENOUS 450MG/45ML (10MG/ML) Prescription No No AP 2006/02/15 FRESENIUS KABI USA
077861 003 ANDA CARBOPLATIN CARBOPLATIN INJECTABLE;INTRAVENOUS 450MG/45ML (10MG/ML) Prescription No No AP 2007/01/18 TEYRO LABS
078280 003 ANDA CARBOPLATIN CARBOPLATIN INJECTABLE;INTRAVENOUS 450MG/45ML (10MG/ML) Prescription No No AP 2008/05/08 SANDOZ
077926 003 ANDA CARBOPLATIN CARBOPLATIN INJECTABLE;INTRAVENOUS 450MG/45ML (10MG/ML) Prescription No No AP 2008/09/19 SUN PHARM
090475 003 ANDA CARBOPLATIN CARBOPLATIN INJECTABLE;INTRAVENOUS 450MG/45ML (10MG/ML) Prescription No No AP 2009/07/29 EPIC PHARMA LLC
205487 003 ANDA CARBOPLATIN CARBOPLATIN INJECTABLE;INTRAVENOUS 450MG/45ML (10MG/ML) Prescription No No AP 2016/03/28 EUGIA PHARMA
206775 003 ANDA CARBOPLATIN CARBOPLATIN INJECTABLE;INTRAVENOUS 450MG/45ML (10MG/ML) Prescription No No AP 2017/02/09 ACCORD HLTHCARE
207324 003 ANDA CARBOPLATIN CARBOPLATIN INJECTABLE;INTRAVENOUS 450MG/45ML (10MG/ML) Prescription No No AP 2017/02/15 GLAND PHARMA LTD
208487 003 ANDA CARBOPLATIN CARBOPLATIN INJECTABLE;INTRAVENOUS 450MG/45ML (10MG/ML) Prescription No No AP 2017/04/26 NOVAST LABS
活性成分:CARBOPLATIN 剂型/给药途径:INJECTABLE;INTRAVENOUS 规格:600MG/60ML (10MG/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
077059 001 ANDA CARBOPLATIN CARBOPLATIN INJECTABLE;INTRAVENOUS 600MG/60ML (10MG/ML) Prescription No Yes AP 2004/11/23 HOSPIRA
077244 004 ANDA CARBOPLATIN CARBOPLATIN INJECTABLE;INTRAVENOUS 600MG/60ML (10MG/ML) Prescription No No AP 2006/01/20 HIKMA
077266 004 ANDA CARBOPLATIN CARBOPLATIN INJECTABLE;INTRAVENOUS 600MG/60ML (10MG/ML) Prescription No No AP 2006/02/15 FRESENIUS KABI USA
077861 004 ANDA CARBOPLATIN CARBOPLATIN INJECTABLE;INTRAVENOUS 600MG/60ML (10MG/ML) Prescription No No AP 2007/01/18 TEYRO LABS
077269 004 ANDA CARBOPLATIN CARBOPLATIN INJECTABLE;INTRAVENOUS 600MG/60ML (10MG/ML) Prescription No No AP 2007/12/28 PHARMACHEMIE BV
091268 002 ANDA CARBOPLATIN CARBOPLATIN INJECTABLE;INTRAVENOUS 600MG/60ML (10MG/ML) Prescription No No AP 2010/07/28 EPIC PHARMA LLC
206775 004 ANDA CARBOPLATIN CARBOPLATIN INJECTABLE;INTRAVENOUS 600MG/60ML (10MG/ML) Prescription No No AP 2017/02/09 ACCORD HLTHCARE
207324 004 ANDA CARBOPLATIN CARBOPLATIN INJECTABLE;INTRAVENOUS 600MG/60ML (10MG/ML) Prescription No No AP 2017/02/15 GLAND PHARMA LTD
208487 004 ANDA CARBOPLATIN CARBOPLATIN INJECTABLE;INTRAVENOUS 600MG/60ML (10MG/ML) Prescription No No AP 2017/04/26 NOVAST LABS
205487 004 ANDA CARBOPLATIN CARBOPLATIN INJECTABLE;INTRAVENOUS 600MG/60ML (10MG/ML) Prescription No No AP 2020/08/03 EUGIA PHARMA
更多信息
药品NDC数据与药品包装、标签说明书
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