药品注册申请号:085055
申请类型:ANDA (仿制药申请)
申请人:JANSSEN PHARMS
申请人全名:JANSSEN 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 TYLENOL W/ CODEINE NO. 1 ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 300MG;7.5MG No No None 1977/08/17 Approved Prior to Jan 1, 1982 Discontinued
002 TYLENOL W/ CODEINE NO. 2 ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 300MG;15MG No No None Approved Prior to Jan 1, 1982 Discontinued
003 TYLENOL W/ CODEINE NO. 3 ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 300MG;30MG No Yes AA Approved Prior to Jan 1, 1982 Prescription
004 TYLENOL W/ CODEINE NO. 4 ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 300MG;60MG No No AA Approved Prior to Jan 1, 1982 Prescription
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2019/10/29 SUPPL 64 Approval Labeling STANDARD
2019/05/06 SUPPL 62 Approval Labeling STANDARD
2019/05/06 SUPPL 56 Approval Labeling STANDARD
2018/09/20 SUPPL 61 Approval Labeling STANDARD
2018/09/18 SUPPL 60 Approval REMS
2017/08/29 SUPPL 59 Approval Labeling STANDARD
2017/03/24 SUPPL 58 Approval Labeling STANDARD
2016/12/16 SUPPL 57 Approval Labeling STANDARD
2014/08/15 SUPPL 54 Approval Labeling STANDARD
2013/05/10 SUPPL 53 Approval Labeling STANDARD
2011/09/15 SUPPL 52 Approval Labeling
2008/07/11 SUPPL 50 Approval Labeling
2007/10/31 SUPPL 49 Approval Labeling
2001/05/31 SUPPL 46 Approval Manufacturing (CMC)
2000/11/02 SUPPL 44 Approval Manufacturing (CMC)
2000/11/02 SUPPL 43 Approval Manufacturing (CMC)
1994/09/23 SUPPL 40 Approval Manufacturing (CMC)
1993/09/24 SUPPL 39 Approval Manufacturing (CMC)
1992/11/12 SUPPL 36 Approval Manufacturing (CMC)
1991/05/07 SUPPL 35 Approval Labeling
1991/03/15 SUPPL 34 Approval Labeling
1990/08/31 SUPPL 32 Approval Labeling
1990/08/31 SUPPL 31 Approval Manufacturing (CMC)
1990/08/31 SUPPL 30 Approval Manufacturing (CMC)
1988/12/23 SUPPL 29 Approval Labeling
1986/12/04 SUPPL 24 Approval Manufacturing (CMC)
1986/12/04 SUPPL 22 Approval Manufacturing (CMC)
1986/12/04 SUPPL 21 Approval Manufacturing (CMC)
1983/10/21 SUPPL 18 Approval Manufacturing (CMC)
1983/10/21 SUPPL 17 Approval Manufacturing (CMC)
1983/08/11 SUPPL 15 Approval Manufacturing (CMC)
1982/12/08 SUPPL 9 Approval Manufacturing (CMC)
1982/12/08 SUPPL 8 Approval Manufacturing (CMC)
1982/12/08 SUPPL 7 Approval Manufacturing (CMC)
1982/12/08 SUPPL 6 Approval Manufacturing (CMC)
1981/12/30 SUPPL 5 Approval Manufacturing (CMC)
1977/08/17 ORIG 1 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
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: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
085055 003 ANDA TYLENOL W/ CODEINE NO. 3 ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 300MG;30MG Prescription No Yes AA Approved Prior to Jan 1, 1982 JANSSEN PHARMS
085868 001 ANDA ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 300MG;30MG Prescription No No AA Approved Prior to Jan 1, 1982 SUN PHARM INDS LTD
088628 001 ANDA ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 300MG;30MG Prescription No No AA 1985/03/06 TEVA
089805 001 ANDA ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 300MG;30MG Prescription No No AA 1988/09/30 VINTAGE
040419 002 ANDA ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 300MG;30MG Prescription No No 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 EYWA
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
085055 004 ANDA TYLENOL W/ CODEINE NO. 4 ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 300MG;60MG Prescription No No AA Approved Prior to Jan 1, 1982 JANSSEN PHARMS
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 Prescription No Yes AA 1985/03/06 TEVA
089828 001 ANDA ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 300MG;60MG Prescription No No AA 1988/09/30 VINTAGE PHARMS
040419 003 ANDA ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 300MG;60MG Prescription No No 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 EYWA
212418 003 ANDA ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 300MG;60MG Prescription No No AA 2019/09/10 ELITE LABS INC
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