药品注册申请号:007337
申请类型:NDA (新药申请)
申请人:ENDO PHARMS
申请人全名:ENDO 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
005 PERCODAN-DEMI ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE TABLET;ORAL 325MG;2.25MG;0.19MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No None 1950/04/12 Approved Prior to Jan 1, 1982 Discontinued
006 PERCODAN ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE TABLET;ORAL 325MG;4.5MG;0.38MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No None Approved Prior to Jan 1, 1982 Discontinued
007 PERCODAN ASPIRIN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;4.8355MG Yes Yes AA 2005/08/05 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-54(补充) Approval Labeling STANDARD
2021/04/28 SUPPL-53(补充) Approval Labeling STANDARD
2019/10/07 SUPPL-52(补充) Approval Labeling STANDARD
2018/09/18 SUPPL-51(补充) Approval Labeling STANDARD
2018/09/18 SUPPL-50(补充) Approval REMS N/A
2016/12/16 SUPPL-49(补充) Approval Labeling STANDARD
2014/01/21 SUPPL-48(补充) Approval Manufacturing (CMC) STANDARD
2013/09/24 SUPPL-47(补充) Approval Manufacturing (CMC) STANDARD
2010/07/28 SUPPL-46(补充) Approval Labeling UNKNOWN
2010/03/11 SUPPL-45(补充) Approval Labeling UNKNOWN
2006/08/11 SUPPL-43(补充) Approval Manufacturing (CMC) STANDARD
2004/06/10 SUPPL-29(补充) Approval Labeling STANDARD
2002/04/29 SUPPL-30(补充) Approval Manufacturing (CMC) STANDARD
1995/03/17 SUPPL-27(补充) Approval Manufacturing (CMC) STANDARD
1994/04/20 SUPPL-23(补充) Approval Manufacturing (CMC) STANDARD
1994/04/19 SUPPL-25(补充) Approval Manufacturing (CMC) STANDARD
1989/06/14 SUPPL-24(补充) Approval Labeling
1987/12/17 SUPPL-22(补充) Approval Manufacturing (CMC) STANDARD
1986/07/10 SUPPL-20(补充) Approval Labeling
1983/11/03 SUPPL-18(补充) Approval Manufacturing (CMC) STANDARD
1982/03/04 SUPPL-16(补充) Approval Manufacturing (CMC) STANDARD
1980/01/24 SUPPL-14(补充) Approval Manufacturing (CMC) STANDARD
1976/01/28 SUPPL-12(补充) Approval Manufacturing (CMC) STANDARD
1975/07/28 SUPPL-11(补充) Approval Labeling
1975/03/31 SUPPL-10(补充) Approval Manufacturing (CMC) STANDARD
1975/03/31 SUPPL-9(补充) Approval Manufacturing (CMC) STANDARD
1950/04/12 ORIG-1(原始申请) Approval Type 4 - New Combination STANDARD
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:ASPIRIN; OXYCODONE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:325MG;4.8355MG 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
007337 007 NDA PERCODAN ASPIRIN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;4.8355MG Prescription Yes Yes AA 2005/08/05 ENDO PHARMS
040910 001 ANDA OXYCODONE AND ASPIRIN ASPIRIN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;4.8355MG Prescription No No AA 2020/07/16 EPIC PHARMA LLC
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