药品注册申请号：018024
申请类型：NDA (新药申请)
申请人：PH HEALTH
申请人全名：PH HEALTH LTD
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 NUBAIN NALBUPHINE HYDROCHLORIDE SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS 10MG/ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1979/05/15 Approved Prior to Jan 1, 1982 Discontinued
002 NUBAIN NALBUPHINE HYDROCHLORIDE SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS 20MG/ML (20MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1982/05/27 Discontinued
003 NUBAIN NALBUPHINE HYDROCHLORIDE SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS 100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
004 NUBAIN NALBUPHINE HYDROCHLORIDE SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS 20MG/2ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
005 NUBAIN NALBUPHINE HYDROCHLORIDE SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS 200MG/10ML (20MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1984/03/02 Discontinued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
1979/05/15 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
2023/12/15 SUPPL-43（补充） Approval Labeling-Package Insert STANDARD
2019/10/07 SUPPL-42（补充） Approval Labeling-Package Insert STANDARD
2016/12/16 SUPPL-41（补充） Approval Labeling-Package Insert STANDARD
2005/08/23 SUPPL-40（补充） Approval Labeling STANDARD
2003/04/30 SUPPL-36（补充） Approval Labeling STANDARD
2002/10/25 SUPPL-39（补充） Approval Manufacturing (CMC)-Control STANDARD
2002/04/16 SUPPL-37（补充） Approval Manufacturing (CMC) STANDARD
2002/01/15 SUPPL-38（补充） Approval Manufacturing (CMC)-Control STANDARD
1995/12/15 SUPPL-35（补充） Approval Manufacturing (CMC)-Control STANDARD
1994/11/02 SUPPL-32（补充） Approval Labeling
1993/10/15 SUPPL-33（补充） Approval Manufacturing (CMC)-Control STANDARD
1990/10/19 SUPPL-31（补充） Approval Manufacturing (CMC) STANDARD
1988/11/10 SUPPL-29（补充） Approval Manufacturing (CMC)-Formulation STANDARD
1988/11/10 SUPPL-27（补充） Approval Labeling
1988/03/03 SUPPL-24（补充） Approval Manufacturing (CMC)-Expiration Date STANDARD
1987/12/07 SUPPL-28（补充） Approval Manufacturing (CMC)-Control STANDARD
1987/08/04 SUPPL-26（补充） Approval Labeling
1986/10/23 SUPPL-16（补充） Approval Efficacy-New Indication
1984/11/28 SUPPL-23（补充） Approval Manufacturing (CMC)-Formulation STANDARD
1984/09/17 SUPPL-20（补充） Approval Manufacturing (CMC)-Control STANDARD
1984/09/13 SUPPL-22（补充） Approval Manufacturing (CMC) STANDARD
1984/09/13 SUPPL-21（补充） Approval Manufacturing (CMC) STANDARD
1984/03/02 SUPPL-15（补充） Approval Manufacturing (CMC)-Expiration Date STANDARD
1984/03/02 SUPPL-14（补充） Approval Manufacturing (CMC)-Formulation STANDARD
1983/08/17 SUPPL-19（补充） Approval Manufacturing (CMC) STANDARD
1983/08/17 SUPPL-18（补充） Approval Manufacturing (CMC) STANDARD
1983/02/16 SUPPL-17（补充） Approval Labeling
1982/05/27 SUPPL-11（补充） Approval Manufacturing (CMC)-Expiration Date STANDARD
1982/05/27 SUPPL-10（补充） Approval Manufacturing (CMC)-Formulation STANDARD
1982/05/20 SUPPL-13（补充） Approval Manufacturing (CMC) STANDARD
1982/05/20 SUPPL-12（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1981/04/01 SUPPL-7（补充） Approval Manufacturing (CMC) STANDARD
1981/02/20 SUPPL-6（补充） Approval Manufacturing (CMC) STANDARD
1980/02/21 SUPPL-3（补充） Approval Manufacturing (CMC) STANDARD
1980/01/24 SUPPL-2（补充） Approval Manufacturing (CMC) STANDARD
1979/06/28 SUPPL-1（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
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
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
参考引用1
参考引用2
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