药品注册申请号：040432
申请类型：ANDA (仿制药申请)
申请人：CHARTWELL
申请人全名：CHARTWELL SCHEDULED LLC
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 HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET;ORAL 325MG;7.5MG No No AA 2003/01/22 2003/01/22 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
2023/12/15 SUPPL-16（补充） Approval Labeling STANDARD
2023/12/15 SUPPL-15（补充） Approval Labeling STANDARD
2021/03/05 SUPPL-14（补充） Approval Labeling STANDARD
2019/10/28 SUPPL-13（补充） Approval Labeling STANDARD
2018/09/21 SUPPL-12（补充） Approval Labeling STANDARD
2018/09/18 SUPPL-11（补充） Approval REMS
2018/08/15 SUPPL-10（补充） Approval Labeling STANDARD
2016/12/16 SUPPL-9（补充） Approval Labeling STANDARD
2016/12/16 SUPPL-8（补充） Approval Labeling STANDARD
2016/02/23 SUPPL-7（补充） Approval Labeling STANDARD
2013/10/18 SUPPL-6（补充） Approval Labeling STANDARD
2011/06/27 SUPPL-5（补充） Approval Labeling
2003/10/10 SUPPL-1（补充） Approval Labeling
2003/01/22 ORIG-1（原始申请） Approval
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
无
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
无
与本品治疗等效的药品
活性成分:ACETAMINOPHEN; HYDROCODONE BITARTRATE 剂型/给药途径:TABLET;ORAL 规格:325MG;7.5MG 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
040405 001 ANDA ANEXSIA 7.5/325 ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET;ORAL 325MG;7.5MG Prescription No Yes AA 2000/09/08 SPECGX LLC
040432 001 ANDA HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET;ORAL 325MG;7.5MG Prescription No No AA 2003/01/22 CHARTWELL
040656 001 ANDA HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET;ORAL 325MG;7.5MG Prescription No No AA 2006/01/19 STRIDES PHARMA
090118 002 ANDA HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET;ORAL 325MG;7.5MG Discontinued No No AA 2008/12/23 SUN PHARM INDS INC
201013 002 ANDA HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET;ORAL 325MG;7.5MG Prescription No No AA 2012/04/11 AUROLIFE PHARMA LLC
202214 002 ANDA HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET;ORAL 325MG;7.5MG Prescription No No AA 2013/03/27 TRIS PHARMA INC
202991 002 ANDA HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET;ORAL 325MG;7.5MG Prescription No No AA 2016/04/12 RHODES PHARMS
040746 002 ANDA HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET;ORAL 325MG;7.5MG Prescription No No AA 2016/05/10 AMNEAL PHARMS NY
202935 003 ANDA HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET;ORAL 325MG;7.5MG Prescription No No AA 2016/06/15 STRIDES PHARMA
209037 002 ANDA HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET;ORAL 325MG;7.5MG Prescription No No AA 2017/06/21 ABHAI LLC
210211 002 ANDA HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET;ORAL 325MG;7.5MG Prescription No No AA 2017/10/30 WES PHARMA INC
203863 002 ANDA HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET;ORAL 325MG;7.5MG Prescription No No AA 2018/03/30 EPIC PHARMA LLC
211487 003 ANDA HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET;ORAL 325MG;7.5MG Prescription No No AA 2018/11/07 ASCENT PHARMS INC
209924 003 ANDA HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET;ORAL 325MG;7.5MG Prescription No No AA 2018/11/16 ELITE LABS INC
211729 002 ANDA HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET;ORAL 325MG;7.5MG Prescription No No AA 2020/01/03 GRANULES
214928 002 ANDA HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET;ORAL 325MG;7.5MG Discontinued No No AA 2021/12/30 PRINSTON INC
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
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