药品注册申请号:216590
申请类型:ANDA (仿制药申请)
申请人:MEITHEAL
申请人全名:MEITHEAL PHARMACEUTICALS 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 LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM INJECTABLE;INJECTION EQ 50MG BASE/VIAL No No AP 2023/07/19 2023/07/19 Prescription
002 LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM INJECTABLE;INJECTION EQ 100MG BASE/VIAL No No AP 2023/07/19 Prescription
003 LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM INJECTABLE;INJECTION EQ 200MG BASE/VIAL No No AP 2023/07/19 Prescription
004 LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM INJECTABLE;INJECTION EQ 350MG BASE/VIAL No No AP 2023/07/19 Prescription
005 LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM INJECTABLE;INJECTION EQ 500MG BASE/VIAL No No AP 2023/07/19 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
2024/04/17 SUPPL-5(补充) Approval Labeling STANDARD
2023/07/19 ORIG-1(原始申请) Approval 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:LEUCOVORIN CALCIUM 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 50MG BASE/VIAL 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
089384 001 ANDA LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM INJECTABLE;INJECTION EQ 50MG BASE/VIAL Prescription No Yes AP 1987/09/14 HIKMA
200753 001 ANDA LEUCOVORIN CALCIUM PRESERVATIVE FREE LEUCOVORIN CALCIUM INJECTABLE;INJECTION EQ 50MG BASE/VIAL Prescription No No AP 2012/09/06 SAGENT PHARMS
217021 001 ANDA LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM INJECTABLE;INJECTION EQ 50MG BASE/VIAL Prescription No No AP 2023/07/10 HAINAN POLY
216590 001 ANDA LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM INJECTABLE;INJECTION EQ 50MG BASE/VIAL Prescription No No AP 2023/07/19 MEITHEAL
活性成分:LEUCOVORIN CALCIUM 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 100MG BASE/VIAL 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
089717 001 ANDA LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM INJECTABLE;INJECTION EQ 100MG BASE/VIAL Prescription No Yes AP 1988/03/28 HIKMA
081277 001 ANDA LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM INJECTABLE;INJECTION EQ 100MG BASE/VIAL Discontinued No No AP 1993/09/28 TEVA PHARMS USA
200753 002 ANDA LEUCOVORIN CALCIUM PRESERVATIVE FREE LEUCOVORIN CALCIUM INJECTABLE;INJECTION EQ 100MG BASE/VIAL Prescription No No AP 2012/09/06 SAGENT PHARMS
203800 001 ANDA LEUCOVORIN CALCIUM PRESERVATIVE FREE LEUCOVORIN CALCIUM INJECTABLE;INJECTION EQ 100MG BASE/VIAL Prescription No No AP 2017/05/19 MYLAN LABS LTD
217021 002 ANDA LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM INJECTABLE;INJECTION EQ 100MG BASE/VIAL Prescription No No AP 2023/07/10 HAINAN POLY
216590 002 ANDA LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM INJECTABLE;INJECTION EQ 100MG BASE/VIAL Prescription No No AP 2023/07/19 MEITHEAL
活性成分:LEUCOVORIN CALCIUM 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 200MG BASE/VIAL 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
040056 001 ANDA LEUCOVORIN CALCIUM PRESERVATIVE FREE LEUCOVORIN CALCIUM INJECTABLE;INJECTION EQ 200MG BASE/VIAL Prescription No Yes AP 1995/05/23 HIKMA
040258 001 ANDA LEUCOVORIN CALCIUM PRESERVATIVE FREE LEUCOVORIN CALCIUM INJECTABLE;INJECTION EQ 200MG BASE/VIAL Prescription No No AP 1999/02/26 FRESENIUS KABI USA
200753 003 ANDA LEUCOVORIN CALCIUM PRESERVATIVE FREE LEUCOVORIN CALCIUM INJECTABLE;INJECTION EQ 200MG BASE/VIAL Prescription No No AP 2012/09/06 SAGENT PHARMS
203800 002 ANDA LEUCOVORIN CALCIUM PRESERVATIVE FREE LEUCOVORIN CALCIUM INJECTABLE;INJECTION EQ 200MG BASE/VIAL Prescription No No AP 2017/05/19 MYLAN LABS LTD
217021 003 ANDA LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM INJECTABLE;INJECTION EQ 200MG BASE/VIAL Prescription No No AP 2023/07/10 HAINAN POLY
216590 003 ANDA LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM INJECTABLE;INJECTION EQ 200MG BASE/VIAL Prescription No No AP 2023/07/19 MEITHEAL
活性成分:LEUCOVORIN CALCIUM 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 350MG BASE/VIAL 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
040174 001 ANDA LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM INJECTABLE;INJECTION EQ 350MG BASE/VIAL Discontinued No No AP 1997/06/12 TEVA PHARMS USA
040335 001 ANDA LEUCOVORIN CALCIUM PRESERVATIVE FREE LEUCOVORIN CALCIUM INJECTABLE;INJECTION EQ 350MG BASE/VIAL Prescription No Yes AP 2000/04/20 HIKMA
200855 001 ANDA LEUCOVORIN CALCIUM PRESERVATIVE FREE LEUCOVORIN CALCIUM INJECTABLE;INJECTION EQ 350MG BASE/VIAL Prescription No No AP 2012/09/06 SAGENT PHARMS
203800 003 ANDA LEUCOVORIN CALCIUM PRESERVATIVE FREE LEUCOVORIN CALCIUM INJECTABLE;INJECTION EQ 350MG BASE/VIAL Prescription No No AP 2017/05/19 MYLAN LABS LTD
216590 004 ANDA LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM INJECTABLE;INJECTION EQ 350MG BASE/VIAL Prescription No No AP 2023/07/19 MEITHEAL
活性成分:LEUCOVORIN CALCIUM 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 500MG BASE/VIAL 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
040286 001 ANDA LEUCOVORIN CALCIUM PRESERVATIVE FREE LEUCOVORIN CALCIUM INJECTABLE;INJECTION EQ 500MG BASE/VIAL Prescription No Yes AP 1999/02/26 FRESENIUS KABI USA
209110 001 ANDA LEUCOVORIN CALCIUM PRESERVATIVE FREE LEUCOVORIN CALCIUM INJECTABLE;INJECTION EQ 500MG BASE/VIAL Prescription No No AP 2017/10/26 SAGENT PHARMS INC
217021 004 ANDA LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM INJECTABLE;INJECTION EQ 500MG BASE/VIAL Prescription No No AP 2023/07/10 HAINAN POLY
216590 005 ANDA LEUCOVORIN CALCIUM LEUCOVORIN CALCIUM INJECTABLE;INJECTION EQ 500MG BASE/VIAL Prescription No No AP 2023/07/19 MEITHEAL
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