药品注册申请号：016822
申请类型：NDA (新药申请)
申请人：B BRAUN
申请人全名：B BRAUN MEDICAL 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 FREAMINE 8.5% AMINO ACIDS INJECTABLE;INJECTION 8.5% (8.5GM/100ML) No No None 1971/09/24 Approved Prior to Jan 1, 1982 Discontinued
002 FREAMINE II 8.5% AMINO ACIDS INJECTABLE;INJECTION 8.5% (8.5GM/100ML) No No None Approved Prior to Jan 1, 1982 Discontinued
003 FREAMINE III 3% W/ ELECTROLYTES AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE INJECTABLE;INJECTION 3%;54MG/100ML;40MG/100ML;150MG/100ML;200MG/100ML;120MG/100ML No No None Approved Prior to Jan 1, 1982 Discontinued
004 FREAMINE III 8.5% AMINO ACIDS INJECTABLE;INJECTION 8.5% (8.5GM/100ML) No No None Approved Prior to Jan 1, 1982 Discontinued
005 FREAMINE III 10% AMINO ACIDS INJECTABLE;INJECTION 10% (10GM/100ML) No No None Approved Prior to Jan 1, 1982 Discontinued
006 FREAMINE HBC 6.9% AMINO ACIDS INJECTABLE;INJECTION 6.9% (6.9GM/100ML) No No None 1983/05/17 Discontinued
007 FREAMINE III 8.5% W/ ELECTROLYTES AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM ACETATE INJECTABLE;INJECTION 8.5%;110MG/100ML;230MG/100ML;10MG/100ML;440MG/100ML;690MG/100ML No No None 1988/07/01 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
1971/09/24 ORIG-1（原始申请） Approval Type 4 - New Combination PRIORITY
>>>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
2014/03/12 SUPPL-72（补充） Approval Manufacturing (CMC) PRIORITY
2013/11/08 SUPPL-81（补充） Approval Manufacturing (CMC) PRIORITY
2013/03/19 SUPPL-74（补充） Approval Manufacturing (CMC) PRIORITY
2013/03/15 SUPPL-75（补充） Approval Manufacturing (CMC) PRIORITY
2013/01/09 SUPPL-77（补充） Approval Manufacturing (CMC) PRIORITY
2004/05/27 SUPPL-65（补充） Approval Manufacturing (CMC)-Control PRIORITY
2000/06/20 SUPPL-64（补充） Approval Manufacturing (CMC)-Control PRIORITY
2000/04/12 SUPPL-63（补充） Approval Manufacturing (CMC)-Control PRIORITY
1999/05/04 SUPPL-62（补充） Approval Manufacturing (CMC)-Control PRIORITY
1996/06/14 SUPPL-61（补充） Approval Manufacturing (CMC)-Control PRIORITY
1995/09/13 SUPPL-60（补充） Approval Manufacturing (CMC)-Control PRIORITY
1994/10/28 SUPPL-59（补充） Approval Manufacturing (CMC) PRIORITY
1993/06/08 SUPPL-58（补充） Approval Manufacturing (CMC)-Control PRIORITY
1992/09/28 SUPPL-57（补充） Approval Manufacturing (CMC) PRIORITY
1991/12/11 SUPPL-56（补充） Approval Manufacturing (CMC) PRIORITY
1990/04/11 SUPPL-55（补充） Approval Manufacturing (CMC)-Control PRIORITY
1988/07/01 SUPPL-44（补充） Approval Labeling
1988/07/01 SUPPL-43（补充） Approval Manufacturing (CMC)-Control PRIORITY
1988/04/11 SUPPL-41（补充） Approval Labeling
1988/04/11 SUPPL-40（补充） Approval Manufacturing (CMC)-Packaging PRIORITY
1988/01/13 SUPPL-52（补充） Approval Labeling
1987/12/28 SUPPL-51（补充） Approval Labeling
1987/07/09 SUPPL-50（补充） Approval Labeling
1987/07/09 SUPPL-49（补充） Approval Labeling
1986/10/08 SUPPL-48（补充） Approval Labeling
1985/10/21 SUPPL-47（补充） Approval Labeling
1985/10/21 SUPPL-46（补充） Approval Labeling
1985/10/15 SUPPL-39（补充） Approval Labeling
1985/10/15 SUPPL-38（补充） Approval Manufacturing (CMC)-Control PRIORITY
1985/07/23 SUPPL-37（补充） Approval Labeling
1985/07/23 SUPPL-36（补充） Approval Manufacturing (CMC)-Control PRIORITY
1985/06/14 SUPPL-45（补充） Approval Manufacturing (CMC)-Control PRIORITY
1984/09/08 SUPPL-42（补充） Approval Labeling
1983/05/17 SUPPL-33（补充） Approval Labeling
1983/05/17 SUPPL-32（补充） Approval Manufacturing (CMC)-Control PRIORITY
1983/04/25 SUPPL-30（补充） Approval Labeling
1982/08/26 SUPPL-34（补充） Approval Manufacturing (CMC)-Control PRIORITY
1982/06/29 SUPPL-35（补充） Approval Manufacturing (CMC)-Formulation PRIORITY
1982/06/17 SUPPL-29（补充） Approval Manufacturing (CMC)-Control PRIORITY
1982/05/03 SUPPL-31（补充） Approval Manufacturing (CMC)-Control PRIORITY
1981/06/20 SUPPL-26（补充） Approval Labeling
1981/06/20 SUPPL-25（补充） Approval Manufacturing (CMC)-Control PRIORITY
1981/05/04 SUPPL-28（补充） Approval Manufacturing (CMC)-Control PRIORITY
1981/04/10 SUPPL-27（补充） Approval Manufacturing (CMC)-Control PRIORITY
1980/12/09 SUPPL-23（补充） Approval Manufacturing (CMC)-Control PRIORITY
1980/11/07 SUPPL-24（补充） Approval Manufacturing (CMC)-Control PRIORITY
1980/08/20 SUPPL-19（补充） Approval Manufacturing (CMC)-Control PRIORITY
1980/08/07 SUPPL-21（补充） Approval Labeling
1980/08/07 SUPPL-20（补充） Approval Manufacturing (CMC)-Control PRIORITY
1980/06/25 SUPPL-22（补充） Approval Manufacturing (CMC)-Expiration Date PRIORITY
1980/06/06 SUPPL-18（补充） Approval Manufacturing (CMC)-Control PRIORITY
1980/04/20 SUPPL-17（补充） Approval Manufacturing (CMC)-Control PRIORITY
1980/04/17 SUPPL-16（补充） Approval Labeling
1980/04/17 SUPPL-15（补充） Approval Manufacturing (CMC)-Control PRIORITY
1978/10/02 SUPPL-12（补充） Approval Labeling
1978/10/02 SUPPL-11（补充） Approval Manufacturing (CMC)-Control PRIORITY
1978/08/18 SUPPL-13（补充） Approval Labeling
1977/09/01 SUPPL-9（补充） Approval Manufacturing (CMC)-Control PRIORITY
1977/07/19 SUPPL-10（补充） Approval Manufacturing (CMC)-Control PRIORITY
1977/05/26 SUPPL-7（补充） Approval Efficacy
1977/05/06 SUPPL-6（补充） Approval Labeling
1975/01/23 SUPPL-5（补充） Approval Manufacturing (CMC)-Control PRIORITY
与本品相关的专利信息（来自FDA橙皮书Orange Book）
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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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