药品注册申请号:015230
申请类型:NDA (新药申请)
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
002 AMICAR AMINOCAPROIC ACID SOLUTION;ORAL 0.25GM/ML Yes Yes AA 1964/06/04 Approved Prior to Jan 1, 1982 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
2009/02/03 SUPPL-37(补充) Approval Labeling STANDARD
2008/08/19 SUPPL-35(补充) Approval Labeling STANDARD
2004/08/24 SUPPL-31(补充) Approval Labeling STANDARD
2003/09/02 SUPPL-30(补充) Approval Manufacturing (CMC) PRIORITY
2003/09/02 SUPPL-29(补充) Approval Manufacturing (CMC) PRIORITY
2003/09/02 SUPPL-28(补充) Approval Manufacturing (CMC) PRIORITY
1999/09/14 SUPPL-27(补充) Approval Manufacturing (CMC) PRIORITY
1999/09/14 SUPPL-26(补充) Approval Manufacturing (CMC) PRIORITY
1999/09/14 SUPPL-25(补充) Approval Manufacturing (CMC) PRIORITY
1997/04/16 SUPPL-23(补充) Approval Labeling STANDARD
1997/01/17 SUPPL-24(补充) Approval Manufacturing (CMC) PRIORITY
1990/04/03 SUPPL-17(补充) Approval Labeling
1986/11/04 SUPPL-22(补充) Approval Manufacturing (CMC) PRIORITY
1986/01/17 SUPPL-21(补充) Approval Labeling
1983/06/06 SUPPL-20(补充) Approval Labeling
1982/12/10 SUPPL-19(补充) Approval Labeling
1982/09/22 SUPPL-18(补充) Approval Manufacturing (CMC) PRIORITY
1980/12/22 SUPPL-15(补充) Approval Manufacturing (CMC) PRIORITY
1978/10/17 SUPPL-12(补充) Approval Manufacturing (CMC) PRIORITY
1964/06/04 ORIG-1(原始申请) Approval Type 3 - New Dosage Form PRIORITY
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:AMINOCAPROIC ACID 剂型/给药途径:SOLUTION;ORAL 规格:0.25GM/ML 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
015230 002 NDA AMICAR AMINOCAPROIC ACID SOLUTION;ORAL 0.25GM/ML Prescription Yes Yes AA Approved Prior to Jan 1, 1982 HIKMA
212780 001 ANDA AMINOCAPROIC ACID AMINOCAPROIC ACID SOLUTION;ORAL 0.25GM/ML Prescription No No AA 2019/08/23 AMNEAL
212814 001 ANDA AMINOCAPROIC ACID AMINOCAPROIC ACID SOLUTION;ORAL 0.25GM/ML Discontinued No No AA 2020/02/26 VISTAPHARM
212494 001 ANDA AMINOCAPROIC ACID AMINOCAPROIC ACID SOLUTION;ORAL 0.25GM/ML Prescription No No AA 2020/08/11 TULEX PHARMS INC
214140 001 ANDA AMINOCAPROIC ACID AMINOCAPROIC ACID SOLUTION;ORAL 0.25GM/ML Prescription No No AA 2021/01/26 CARNEGIE
213825 001 ANDA AMINOCAPROIC ACID AMINOCAPROIC ACID SOLUTION;ORAL 0.25GM/ML Prescription No No AA 2021/04/08 BELCHER
215510 001 ANDA AMINOCAPROIC ACID AMINOCAPROIC ACID SOLUTION;ORAL 0.25GM/ML Prescription No No AA 2022/03/23 FLORIDA
216804 001 ANDA AMINOCAPROIC ACID AMINOCAPROIC ACID SOLUTION;ORAL 0.25GM/ML Prescription No No AA 2022/09/26 AUROBINDO PHARMA
216464 001 ANDA AMINOCAPROIC ACID AMINOCAPROIC ACID SOLUTION;ORAL 0.25GM/ML Prescription No No AA 2022/11/04 ANNORA PHARMA
214458 001 ANDA AMINOCAPROIC ACID AMINOCAPROIC ACID SOLUTION;ORAL 0.25GM/ML Prescription No No AA 2023/03/24 TARO
213213 001 ANDA AMINOCAPROIC ACID AMINOCAPROIC ACID SOLUTION;ORAL 0.25GM/ML Prescription No No AA 2023/12/27 SUNNY
更多信息
药品NDC数据与药品包装、标签说明书
©2006-2024 DrugFuture->U.S. FDA Drugs Database