药品注册申请号:019257
申请类型:NDA (新药申请)
申请人:LEADIANT BIOSCI INC
申请人全名:LEADIANT BIOSCIENCES 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 CARNITOR LEVOCARNITINE SOLUTION;ORAL 1GM/10ML Yes Yes AA 1986/04/10 1986/04/10 Prescription
002 CARNITOR SF LEVOCARNITINE SOLUTION;ORAL 1GM/10ML Yes No AA 2007/03/28 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
2018/04/17 SUPPL-14(补充) Approval Labeling STANDARD ;Orphan
2015/05/29 SUPPL-12(补充) Approval Labeling STANDARD
2007/03/28 SUPPL-11(补充) Approval Manufacturing (CMC) N/A
2002/04/15 SUPPL-10(补充) Approval Labeling STANDARD
1998/12/15 SUPPL-9(补充) Approval Labeling STANDARD
1997/01/27 SUPPL-8(补充) Approval Manufacturing (CMC) PRIORITY
1995/10/17 SUPPL-7(补充) Approval Manufacturing (CMC) PRIORITY
1995/05/12 SUPPL-6(补充) Approval Manufacturing (CMC) PRIORITY
1990/04/25 SUPPL-4(补充) Approval Manufacturing (CMC) PRIORITY
1989/01/12 SUPPL-2(补充) Approval Manufacturing (CMC) PRIORITY
1988/05/11 SUPPL-3(补充) Approval Manufacturing (CMC) PRIORITY
1986/08/29 SUPPL-1(补充) Approval Manufacturing (CMC) PRIORITY ;Orphan
1986/04/10 ORIG-1(原始申请) Approval Type 3 - New Dosage Form PRIORITY ;Orphan
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:LEVOCARNITINE 剂型/给药途径:SOLUTION;ORAL 规格:1GM/10ML 治疗等效代码:AA
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
019257 001 NDA CARNITOR LEVOCARNITINE SOLUTION;ORAL 1GM/10ML Prescription Yes Yes AA 1986/04/10 LEADIANT BIOSCI INC
076851 001 ANDA LEVOCARNITINE LEVOCARNITINE SOLUTION;ORAL 1GM/10ML Prescription No No AA 2004/08/10 RISING
019257 002 NDA CARNITOR SF LEVOCARNITINE SOLUTION;ORAL 1GM/10ML Prescription Yes No AA 2007/03/28 LEADIANT BIOSCI INC
077399 001 ANDA LEVOCARNITINE LEVOCARNITINE SOLUTION;ORAL 1GM/10ML Discontinued No No AA 2007/10/25 HIKMA
211676 001 ANDA LEVOCARNITINE LEVOCARNITINE SOLUTION;ORAL 1GM/10ML Prescription No No AA 2019/08/14 NOVITIUM PHARMA
211676 002 ANDA LEVOCARNITINE SF LEVOCARNITINE SOLUTION;ORAL 1GM/10ML Prescription No No AA 2019/08/14 NOVITIUM PHARMA
212533 001 ANDA LEVOCARNITINE LEVOCARNITINE SOLUTION;ORAL 1GM/10ML Prescription No No AA 2021/11/10 SCIEGEN PHARMS INC
活性成分:LEVOCARNITINE 剂型/给药途径:SOLUTION;ORAL 规格:1GM/10ML 治疗等效代码:AA
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
019257 001 NDA CARNITOR LEVOCARNITINE SOLUTION;ORAL 1GM/10ML Prescription Yes Yes AA 1986/04/10 LEADIANT BIOSCI INC
076851 001 ANDA LEVOCARNITINE LEVOCARNITINE SOLUTION;ORAL 1GM/10ML Prescription No No AA 2004/08/10 RISING
019257 002 NDA CARNITOR SF LEVOCARNITINE SOLUTION;ORAL 1GM/10ML Prescription Yes No AA 2007/03/28 LEADIANT BIOSCI INC
077399 001 ANDA LEVOCARNITINE LEVOCARNITINE SOLUTION;ORAL 1GM/10ML Discontinued No No AA 2007/10/25 HIKMA
211676 001 ANDA LEVOCARNITINE LEVOCARNITINE SOLUTION;ORAL 1GM/10ML Prescription No No AA 2019/08/14 NOVITIUM PHARMA
211676 002 ANDA LEVOCARNITINE SF LEVOCARNITINE SOLUTION;ORAL 1GM/10ML Prescription No No AA 2019/08/14 NOVITIUM PHARMA
212533 001 ANDA LEVOCARNITINE LEVOCARNITINE SOLUTION;ORAL 1GM/10ML Prescription No No AA 2021/11/10 SCIEGEN PHARMS INC
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