药品注册申请号：018692
申请类型：NDA (新药申请)
申请人：HOSPIRA
申请人全名：HOSPIRA 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 MARCAINE BUPIVACAINE HYDROCHLORIDE INJECTABLE;SPINAL 0.75% Yes Yes AP 1984/05/04 1984/05/04 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
2018/11/02 SUPPL 20 Approval Labeling STANDARD
2014/09/19 SUPPL 16 Approval Manufacturing (CMC) STANDARD
2012/01/30 SUPPL 15 Approval Labeling STANDARD
2010/02/19 SUPPL 14 Approval Labeling 901 REQUIRED
2003/06/12 SUPPL 7 Approval Labeling STANDARD
2001/08/21 SUPPL 4 Approval Manufacturing (CMC) STANDARD
1999/03/09 SUPPL 3 Approval Labeling STANDARD
1999/03/09 SUPPL 2 Approval Labeling
1987/06/26 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1984/05/04 ORIG 1 Approval Type 3 - New Dosage Form 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
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
活性成分:BUPIVACAINE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;SPINAL 规格:0.75% 治疗等效代码:AP
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
018692 001 NDA MARCAINE BUPIVACAINE HYDROCHLORIDE INJECTABLE;SPINAL 0.75% Prescription Yes Yes AP 1984/05/04 HOSPIRA
071810 001 ANDA BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE INJECTABLE;SPINAL 0.75% Prescription No No AP 1987/12/11 HOSPIRA
207266 001 ANDA BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE INJECTABLE;SPINAL 0.75% Prescription No No AP 2016/07/25 BAXTER HLTHCARE CORP
209087 001 ANDA BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE INJECTABLE;SPINAL 0.75% Prescription No No AP 2019/04/02 B BRAUN MEDICAL INC
212822 001 ANDA BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE INJECTABLE;SPINAL 0.75% Prescription No No AP 2019/12/30 HUONS
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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