药品注册申请号：040419
申请类型：ANDA (仿制药申请)
申请人：SPECGX LLC
申请人全名：SPECGX 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 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 300MG;15MG No Yes AA 2001/05/31 2001/05/31 Prescription
002 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 300MG;30MG No Yes AA 2001/05/31 Prescription
003 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 300MG;60MG No Yes AA 2001/05/31 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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2001/05/31 ORIG-1（原始申请） Approval
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2025/03/10 SUPPL-37（补充） Approval Labeling-Package Insert,Labeling-Medication Guide STANDARD
2024/10/31 SUPPL-38（补充） Approval REMS-Modified
2023/12/15 SUPPL-36（补充） Approval Labeling-Package Insert STANDARD
2023/12/15 SUPPL-35（补充） Approval Labeling-Package Insert STANDARD
2021/03/04 SUPPL-29（补充） Approval Labeling-Package Insert,Labeling-Medication Guide STANDARD
2019/10/07 SUPPL-26（补充） Approval Labeling-Package Insert,Labeling-Medication Guide STANDARD
2018/09/20 SUPPL-25（补充） Approval Labeling-Medication Guide,Labeling-Package Insert STANDARD
2018/09/18 SUPPL-24（补充） Approval REMS - PROPOSAL - D-N-A
2018/04/06 SUPPL-23（补充） Approval Labeling-Medication Guide,Labeling-Package Insert STANDARD
2018/04/06 SUPPL-21（补充） Approval Labeling-Medication Guide,Labeling-Package Insert STANDARD
2016/12/16 SUPPL-19（补充） Approval Labeling-Medication Guide,Labeling-Package Insert STANDARD
2016/12/16 SUPPL-17（补充） Approval Labeling-Medication Guide,Labeling-Package Insert STANDARD
2013/10/18 SUPPL-16（补充） Approval Labeling-Package Insert STANDARD
2013/05/10 SUPPL-14（补充） Approval Labeling-Package Insert STANDARD
2011/06/22 SUPPL-12（补充） Approval Labeling-Package Insert
2008/02/21 SUPPL-11（补充） Approval Labeling
2007/11/30 SUPPL-10（补充） Approval Labeling
2002/12/13 SUPPL-4（补充） Approval Labeling
2002/12/13 SUPPL-3（补充） Approval Manufacturing (CMC)-Facility
2002/12/13 SUPPL-2（补充） Approval Manufacturing (CMC)-Packaging
2002/04/11 SUPPL-1（补充） Approval Manufacturing (CMC)-Facility
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; CODEINE PHOSPHATE; 剂型/给药途径:TABLET;ORAL; 规格:300MG;15MG; 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
088629 002 ANDA ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 300MG;15MG Discontinued No No AA 1985/03/06 ANI PHARMS
089990 001 ANDA ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 300MG;15MG Prescription No No AA 1988/09/30 STRIDES PHARMA INTL
040419 001 ANDA ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 300MG;15MG Prescription No Yes AA 2001/05/31 SPECGX LLC
202800 001 ANDA ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 300MG;15MG Prescription No No AA 2013/04/15 AUROLIFE PHARMA LLC
211610 001 ANDA ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 300MG;15MG Prescription No No AA 2019/06/27 HIBROW HLTHCARE
212418 001 ANDA ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 300MG;15MG Prescription No No AA 2019/09/10 ELITE LABS INC
>>>活性成分:ACETAMINOPHEN; CODEINE PHOSPHATE; 剂型/给药途径:TABLET;ORAL; 规格:300MG;30MG; 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
085868 001 ANDA ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 300MG;30MG Discontinued No No AA Approved Prior to Jan 1, 1982 SUN PHARM INDS LTD
088629 003 ANDA ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 300MG;30MG Discontinued No No AA 1985/03/06 ANI PHARMS
089805 001 ANDA ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 300MG;30MG Prescription No No AA 1988/09/30 STRIDES PHARMA INTL
040419 002 ANDA ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 300MG;30MG Prescription No Yes AA 2001/05/31 SPECGX LLC
040779 001 ANDA ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 300MG;30MG Prescription No No AA 2008/05/29 AMNEAL PHARMS NY
202800 002 ANDA ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 300MG;30MG Prescription No No AA 2013/04/15 AUROLIFE PHARMA LLC
211610 002 ANDA ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 300MG;30MG Prescription No No AA 2019/06/27 HIBROW HLTHCARE
212418 002 ANDA ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 300MG;30MG Prescription No No AA 2019/09/10 ELITE LABS INC
>>>活性成分:ACETAMINOPHEN; CODEINE PHOSPHATE; 剂型/给药途径:TABLET;ORAL; 规格:300MG;60MG; 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
087083 001 ANDA ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 300MG;60MG Prescription No No AA Approved Prior to Jan 1, 1982 SUN PHARM INDS LTD
088629 001 ANDA ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 300MG;60MG Discontinued Yes No AA 1985/03/06 ANI PHARMS
089828 001 ANDA ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 300MG;60MG Prescription No No AA 1988/09/30 STRIDES PHARMA INTL
040419 003 ANDA ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 300MG;60MG Prescription No Yes AA 2001/05/31 SPECGX LLC
202800 003 ANDA ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 300MG;60MG Prescription No No AA 2013/04/15 AUROLIFE PHARMA LLC
211610 003 ANDA ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 300MG;60MG Prescription No No AA 2019/06/27 HIBROW HLTHCARE
212418 003 ANDA ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 300MG;60MG Prescription No No AA 2019/09/10 ELITE LABS 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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