药品注册申请号:021539
申请类型:NDA (新药申请)
申请人:CUMBERLAND PHARMS
申请人全名:CUMBERLAND 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 ACETADOTE ACETYLCYSTEINE INJECTABLE;INTRAVENOUS 6GM/30ML (200MG/ML) Yes Yes AP 2004/01/23 2004/01/23 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
2021/09/27 SUPPL-20(补充) Approval Labeling STANDARD ;Orphan
2019/10/30 SUPPL-17(补充) Approval Labeling STANDARD ;Orphan
2017/01/23 SUPPL-16(补充) Approval Labeling STANDARD ;Orphan
2016/07/29 SUPPL-15(补充) Approval Labeling STANDARD ;Orphan
2013/06/05 SUPPL-12(补充) Approval Labeling UNKNOWN
2013/01/15 SUPPL-13(补充) Approval Manufacturing (CMC) PRIORITY
2011/01/07 SUPPL-10(补充) Approval Manufacturing (CMC) PRIORITY
2008/12/12 SUPPL-5(补充) Approval Labeling STANDARD
2006/02/15 SUPPL-4(补充) Approval Labeling STANDARD
2004/04/28 SUPPL-2(补充) Approval Labeling STANDARD
2004/04/28 SUPPL-1(补充) Approval Labeling STANDARD ;Orphan
2004/01/23 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 8148356 2026/05/21 Y 2012/04/04 PDF格式
8399445 2025/08/24 U-1373 2013/03/28 PDF格式
8653061 2025/08/24 U-1373 2014/02/24 PDF格式
8722738 2032/04/06 U-1373 2014/05/27 PDF格式
9327028 2031/07/21 U-1839 2016/05/18 PDF格式
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
001 ODE 2011/01/23**本条是由Drugfuture回溯的历史信息**
与本品治疗等效的药品
活性成分:ACETYLCYSTEINE 剂型/给药途径:INJECTABLE;INTRAVENOUS 规格:6GM/30ML (200MG/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
021539 001 NDA ACETADOTE ACETYLCYSTEINE INJECTABLE;INTRAVENOUS 6GM/30ML (200MG/ML) Prescription Yes Yes AP 2004/01/23 CUMBERLAND PHARMS
200644 001 ANDA ACETYLCYSTEINE ACETYLCYSTEINE INJECTABLE;INTRAVENOUS 6GM/30ML (200MG/ML) Prescription No No AP 2012/11/07 FRESENIUS KABI USA
203173 001 ANDA ACETYLCYSTEINE ACETYLCYSTEINE INJECTABLE;INTRAVENOUS 6GM/30ML (200MG/ML) Prescription No No AP 2015/03/24 RISING
207358 001 ANDA ACETYLCYSTEINE ACETYLCYSTEINE INJECTABLE;INTRAVENOUS 6GM/30ML (200MG/ML) Prescription No No AP 2016/02/29 EUGIA PHARMA
091684 001 ANDA ACETYLCYSTEINE ACETYLCYSTEINE INJECTABLE;INTRAVENOUS 6GM/30ML (200MG/ML) Prescription No No AP 2017/10/31 SAGENT PHARMS INC
208166 001 ANDA ACETYLCYSTEINE ACETYLCYSTEINE INJECTABLE;INTRAVENOUS 6GM/30ML (200MG/ML) Prescription No No AP 2018/07/20 ZYDUS PHARMS
213693 001 ANDA ACETYLCYSTEINE ACETYLCYSTEINE INJECTABLE;INTRAVENOUS 6GM/30ML (200MG/ML) Prescription No No AP 2022/02/03 ASPEN
215620 001 ANDA ACETYLCYSTEINE ACETYLCYSTEINE INJECTABLE;INTRAVENOUS 6GM/30ML (200MG/ML) Prescription No No AP 2022/02/23 INDOCO
217182 001 ANDA ACETYLCYSTEINE ACETYLCYSTEINE INJECTABLE;INTRAVENOUS 6GM/30ML (200MG/ML) Prescription No No AP 2023/04/19 STERISCIENCE
更多信息
药品NDC数据与药品包装、标签说明书
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