药品注册申请号：005010
申请类型：NDA (新药申请)
申请人：QUAGEN
申请人全名：QUAGEN PHARMACEUTICALS 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 DEMEROL MEPERIDINE HYDROCHLORIDE TABLET;ORAL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1942/11/10 Approved Prior to Jan 1, 1982 Discontinued
002 DEMEROL MEPERIDINE HYDROCHLORIDE INJECTABLE;INJECTION 50MG/ML No No None Approved Prior to Jan 1, 1982 Discontinued
003 DEMEROL MEPERIDINE HYDROCHLORIDE INJECTABLE;INJECTION 100MG/ML No No None Approved Prior to Jan 1, 1982 Discontinued
004 DEMEROL MEPERIDINE HYDROCHLORIDE TABLET;ORAL 100MG Yes No None Approved Prior to Jan 1, 1982 Discontinued
005 DEMEROL MEPERIDINE HYDROCHLORIDE SYRUP;ORAL 50MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No None Approved Prior to Jan 1, 1982 Discontinued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 DEMEROL MEPERIDINE HYDROCHLORIDE INJECTABLE;INJECTION 25MG/ML No No None Approved Prior to Jan 1, 1982 Discontinued
009 DEMEROL MEPERIDINE HYDROCHLORIDE INJECTABLE;INJECTION 75MG/ML No No None Approved Prior to Jan 1, 1982 Discontinued
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
1942/11/10 ORIG-1（原始申请） Approval Type 1 - New Molecular Entity STANDARD
>>>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
2024/10/31 SUPPL-61（补充） Approval REMS - MODIFIED - D-N-A N/A
2023/12/15 SUPPL-60（补充） Approval Labeling-Package Insert,Labeling-Medication Guide STANDARD
2021/03/04 SUPPL-59（补充） Approval Labeling-Package Insert,Labeling-Medication Guide STANDARD
2019/10/07 SUPPL-58（补充） Approval Labeling-Package Insert,Labeling-Medication Guide STANDARD
2018/09/18 SUPPL-57（补充） Approval Labeling-Package Insert STANDARD
2018/09/18 SUPPL-56（补充） Approval REMS - PROPOSAL - D-N-A N/A
2017/08/16 SUPPL-55（补充） Approval Labeling-Package Insert,Labeling-Medication Guide STANDARD
2016/12/16 SUPPL-54（补充） Approval Labeling-Package Insert,Labeling-Package Insert,Labeling-Package Insert STANDARD
2011/10/31 SUPPL-51（补充） Approval Labeling-Package Insert STANDARD
2011/04/11 SUPPL-50（补充） Approval Labeling STANDARD
2009/03/05 SUPPL-49（补充） Approval Labeling STANDARD
2003/05/15 SUPPL-48（补充） Approval Labeling STANDARD
2003/02/26 SUPPL-47（补充） Approval Labeling STANDARD
2000/10/17 SUPPL-46（补充） Approval Manufacturing (CMC)-Control STANDARD
1997/07/24 SUPPL-31（补充） Approval Labeling
1995/10/10 SUPPL-45（补充） Approval Manufacturing (CMC)-Control STANDARD
1995/03/16 SUPPL-44（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1995/03/16 SUPPL-43（补充） Approval Manufacturing (CMC)-Control STANDARD
1995/03/16 SUPPL-42（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1992/09/29 SUPPL-40（补充） Approval Manufacturing (CMC)-Control STANDARD
1992/09/29 SUPPL-39（补充） Approval Manufacturing (CMC)-Control STANDARD
1992/09/10 SUPPL-41（补充） Approval Manufacturing (CMC)-Control STANDARD
1992/07/30 SUPPL-38（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1991/02/12 SUPPL-37（补充） Approval Manufacturing (CMC) STANDARD
1990/09/12 SUPPL-36（补充） Approval Manufacturing (CMC) STANDARD
1990/01/25 SUPPL-35（补充） Approval Manufacturing (CMC) STANDARD
1989/05/25 SUPPL-33（补充） Approval Manufacturing (CMC) STANDARD
1989/05/24 SUPPL-34（补充） Approval Manufacturing (CMC) STANDARD
1989/04/03 SUPPL-32（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1988/01/06 SUPPL-30（补充） Approval Labeling
1986/07/18 SUPPL-29（补充） Approval Labeling
1986/05/12 SUPPL-28（补充） Approval Manufacturing (CMC)-Control STANDARD
1985/06/04 SUPPL-27（补充） Approval Manufacturing (CMC)-Control STANDARD
1985/05/20 SUPPL-26（补充） Approval Manufacturing (CMC) STANDARD
1985/05/20 SUPPL-25（补充） Approval Manufacturing (CMC)-Control STANDARD
1984/01/17 SUPPL-24（补充） Approval Manufacturing (CMC)-Control STANDARD
1983/03/28 SUPPL-23（补充） Approval Manufacturing (CMC)-Control STANDARD
1983/03/28 SUPPL-22（补充） Approval Labeling
1983/03/28 SUPPL-21（补充） Approval Manufacturing (CMC)-Control STANDARD
1983/03/28 SUPPL-20（补充） Approval Manufacturing (CMC)-Control STANDARD
1983/03/28 SUPPL-19（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1983/03/28 SUPPL-18（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1982/09/07 SUPPL-17（补充） Approval Manufacturing (CMC)-Control STANDARD
1979/07/26 SUPPL-14（补充） Approval Labeling
1978/07/27 SUPPL-12（补充） Approval Labeling
1978/07/21 SUPPL-13（补充） Approval Labeling
1978/01/04 SUPPL-10（补充） Approval Manufacturing (CMC) STANDARD
1977/12/02 SUPPL-11（补充） Approval Manufacturing (CMC)-Control STANDARD
1976/08/10 SUPPL-9（补充） Approval Manufacturing (CMC)-Formulation STANDARD
1976/05/04 SUPPL-8（补充） Approval Labeling
1974/01/18 SUPPL-4（补充） Approval Labeling
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
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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
本品无治疗等效药品
更多信息
药品NDC数据与药品包装、标签说明书
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