药品注册申请号:012250
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 CARBOCAINE MEPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 1% Yes Yes AP 1960/05/17 Approved Prior to Jan 1, 1982 Prescription
002 CARBOCAINE MEPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 2% Yes Yes AP Approved Prior to Jan 1, 1982 Prescription
005 CARBOCAINE MEPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 1.5% Yes Yes AP Approved Prior to Jan 1, 1982 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
2023/12/21 SUPPL-40(补充) Approval Labeling STANDARD
2018/11/02 SUPPL-37(补充) Approval Labeling STANDARD
2010/02/19 SUPPL-33(补充) Approval Labeling 901 REQUIRED
2005/09/28 SUPPL-28(补充) Approval Labeling STANDARD
2001/01/31 SUPPL-23(补充) Approval Manufacturing (CMC) PRIORITY
1999/04/27 SUPPL-19(补充) Approval Labeling
1999/03/11 SUPPL-22(补充) Approval Labeling STANDARD
1991/05/21 SUPPL-20(补充) Approval Manufacturing (CMC) PRIORITY
1987/01/29 SUPPL-16(补充) Approval Labeling
1985/03/15 SUPPL-18(补充) Approval Manufacturing (CMC) PRIORITY
1984/03/30 SUPPL-17(补充) Approval Manufacturing (CMC) PRIORITY
1981/08/21 SUPPL-15(补充) Approval Manufacturing (CMC) PRIORITY
1980/10/03 SUPPL-14(补充) Approval Manufacturing (CMC) PRIORITY
1979/06/26 SUPPL-12(补充) Approval Labeling
1978/06/15 SUPPL-13(补充) Approval Manufacturing (CMC) PRIORITY
1976/10/06 SUPPL-10(补充) Approval Manufacturing (CMC) PRIORITY
1975/10/28 SUPPL-8(补充) Approval Labeling
1974/04/15 SUPPL-7(补充) Approval Labeling
1960/05/17 ORIG-1(原始申请) Approval Type 3 - New Dosage Form PRIORITY
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:MEPIVACAINE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:1% 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
012250 001 NDA CARBOCAINE MEPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 1% Prescription Yes Yes AP Approved Prior to Jan 1, 1982 HOSPIRA
089406 001 ANDA POLOCAINE-MPF MEPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 1% Prescription No No AP 1986/12/01 FRESENIUS KABI USA
089407 001 ANDA POLOCAINE MEPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 1% Prescription No No AP 1986/12/01 FRESENIUS KABI USA
活性成分:MEPIVACAINE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:2% 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
012250 002 NDA CARBOCAINE MEPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 2% Prescription Yes Yes AP Approved Prior to Jan 1, 1982 HOSPIRA
089409 001 ANDA POLOCAINE-MPF MEPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 2% Prescription No No AP 1986/12/01 FRESENIUS KABI USA
089410 001 ANDA POLOCAINE MEPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 2% Prescription No No AP 1986/12/01 FRESENIUS KABI USA
活性成分:MEPIVACAINE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:1.5% 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
012250 005 NDA CARBOCAINE MEPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 1.5% Prescription Yes Yes AP Approved Prior to Jan 1, 1982 HOSPIRA
089408 001 ANDA POLOCAINE-MPF MEPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 1.5% Prescription No No AP 1986/12/01 FRESENIUS KABI USA
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