药品注册申请号:050753
申请类型:NDA (新药申请)
申请人:MYLAN SPECIALITY LP
申请人全名:MYLAN SPECIALTY LP
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 TOBI TOBRAMYCIN SOLUTION;INHALATION 300MG/5ML Yes Yes AN 1997/12/22 1997/12/22 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
2023/02/10 SUPPL-28(补充) Approval Labeling STANDARD ;Orphan
2018/12/20 SUPPL-23(补充) Approval Labeling STANDARD ;Orphan
2018/10/05 SUPPL-22(补充) Approval Labeling STANDARD ;Orphan
2016/04/29 SUPPL-19(补充) Approval Manufacturing (CMC) PRIORITY
2015/10/05 SUPPL-18(补充) Approval Labeling STANDARD ;Orphan
2015/04/14 SUPPL-17(补充) Approval Manufacturing (CMC) PRIORITY
2014/04/25 SUPPL-16(补充) Approval Labeling STANDARD
2013/10/24 SUPPL-15(补充) Approval Manufacturing (CMC) PRIORITY
2013/09/26 SUPPL-11(补充) Approval Labeling STANDARD
2008/10/16 SUPPL-9(补充) Approval Labeling STANDARD
2005/08/05 SUPPL-7(补充) Approval Labeling STANDARD
2002/03/21 SUPPL-2(补充) Approval Labeling STANDARD
2001/09/05 SUPPL-4(补充) Approval Manufacturing (CMC) PRIORITY
2000/05/18 SUPPL-3(补充) Approval Manufacturing (CMC) PRIORITY
1998/09/11 SUPPL-1(补充) Approval Labeling STANDARD ;Orphan
1997/12/22 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
001 5508269 2014/10/19 Y U-909 PDF格式**本条是由Drugfuture回溯的历史信息**
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:TOBRAMYCIN 剂型/给药途径:SOLUTION;INHALATION 规格:300MG/5ML 治疗等效代码:AN
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
050753 001 NDA TOBI TOBRAMYCIN SOLUTION;INHALATION 300MG/5ML Prescription Yes Yes AN 1997/12/22 MYLAN SPECIALITY LP
091589 001 ANDA TOBRAMYCIN TOBRAMYCIN SOLUTION;INHALATION 300MG/5ML Prescription No No AN 2013/10/10 TEVA PHARMS USA
201422 001 ANDA TOBRAMYCIN TOBRAMYCIN SOLUTION;INHALATION 300MG/5ML Prescription No No AN 2014/05/28 HIKMA
205433 001 NDA KITABIS PAK TOBRAMYCIN SOLUTION;INHALATION 300MG/5ML Prescription No No AN 2014/12/02 PULMOFLOW INC
205501 001 ANDA TOBRAMYCIN TOBRAMYCIN SOLUTION;INHALATION 300MG/5ML Prescription No No AN 2015/07/13 AMNEAL PHARMS
208964 001 ANDA TOBRAMYCIN TOBRAMYCIN SOLUTION;INHALATION 300MG/5ML Prescription No No AN 2017/03/22 LUPIN
207080 001 ANDA TOBRAMYCIN TOBRAMYCIN SOLUTION;INHALATION 300MG/5ML Prescription No No AN 2018/07/09 DR REDDYS LABS SA
207136 001 ANDA TOBRAMYCIN TOBRAMYCIN SOLUTION;INHALATION 300MG/5ML Prescription No No AN 2019/12/26 SUN PHARM
212848 001 ANDA TOBRAMYCIN TOBRAMYCIN SOLUTION;INHALATION 300MG/5ML Prescription No No AN 2021/04/01 ALKEM LABS LTD
214478 001 ANDA TOBRAMYCIN TOBRAMYCIN SOLUTION;INHALATION 300MG/5ML Prescription No No AN 2023/06/30 MANKIND PHARMA
217344 001 ANDA TOBRAMYCIN TOBRAMYCIN SOLUTION;INHALATION 300MG/5ML Prescription No No AN 2023/07/27 MICRO LABS
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药品NDC数据与药品包装、标签说明书
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