药品注册申请号:017106
申请类型:NDA (新药申请)
申请人:MMT
申请人全名:MERIDIAN MEDICAL TECHNOLOGIES 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 ATROPEN ATROPINE SOLUTION;INTRAMUSCULAR EQ 2MG SULFATE/0.7ML Yes No None 1973/05/15 Approved Prior to Jan 1, 1982 Discontinued
002 ATROPEN ATROPINE SOLUTION;INTRAMUSCULAR EQ 1MG SULFATE/0.7ML Yes No None 2003/06/19 Discontinued
003 ATROPEN ATROPINE SOLUTION;INTRAMUSCULAR EQ 0.5MG SULFATE/0.7ML Yes No None 2003/06/19 Discontinued
004 ATROPEN ATROPINE SOLUTION;INTRAMUSCULAR EQ 0.25MG SULFATE/0.3ML Yes No None 2004/09/17 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
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
2020/11/20 SUPPL-52(补充) Approval Labeling STANDARD
2016/05/27 SUPPL-49(补充) Approval Manufacturing (CMC) PRIORITY
2015/08/10 SUPPL-51(补充) Approval Manufacturing (CMC) PRIORITY
2013/11/14 SUPPL-45(补充) Approval Manufacturing (CMC) PRIORITY
2004/09/17 SUPPL-32(补充) Approval Manufacturing (CMC) PRIORITY
2003/06/19 SUPPL-28(补充) Approval Efficacy PRIORITY
2002/06/28 SUPPL-27(补充) Approval Manufacturing (CMC) PRIORITY
2002/03/04 SUPPL-25(补充) Approval Manufacturing (CMC) PRIORITY
2002/01/07 SUPPL-26(补充) Approval Manufacturing (CMC) PRIORITY
2001/06/08 SUPPL-24(补充) Approval Manufacturing (CMC) PRIORITY
2001/02/13 SUPPL-23(补充) Approval Manufacturing (CMC) PRIORITY
2001/01/31 SUPPL-22(补充) Approval Manufacturing (CMC) PRIORITY
2000/10/19 SUPPL-21(补充) Approval Manufacturing (CMC) PRIORITY
2000/08/18 SUPPL-19(补充) Approval Manufacturing (CMC) PRIORITY
2000/08/16 SUPPL-20(补充) Approval Manufacturing (CMC) PRIORITY
1999/10/28 SUPPL-18(补充) Approval Manufacturing (CMC) PRIORITY
1999/04/26 SUPPL-17(补充) Approval Manufacturing (CMC) PRIORITY
1999/03/16 SUPPL-16(补充) Approval Manufacturing (CMC) PRIORITY
1998/08/25 SUPPL-15(补充) Approval Manufacturing (CMC) PRIORITY
1998/04/21 SUPPL-14(补充) Approval Labeling STANDARD
1997/03/06 SUPPL-13(补充) Approval Manufacturing (CMC) PRIORITY
1996/12/17 SUPPL-12(补充) Approval Manufacturing (CMC) PRIORITY
1991/03/05 SUPPL-11(补充) Approval Manufacturing (CMC) PRIORITY
1990/08/17 SUPPL-10(补充) Approval Manufacturing (CMC) PRIORITY
1989/04/04 SUPPL-9(补充) Approval Manufacturing (CMC) PRIORITY
1987/08/19 SUPPL-8(补充) Approval Manufacturing (CMC) PRIORITY
1986/10/06 SUPPL-7(补充) Approval Manufacturing (CMC) PRIORITY
1985/01/14 SUPPL-6(补充) Approval Manufacturing (CMC) PRIORITY
1984/06/06 SUPPL-5(补充) Approval Labeling
1979/12/27 SUPPL-4(补充) Approval Manufacturing (CMC) PRIORITY
1979/05/10 SUPPL-3(补充) Approval Manufacturing (CMC) PRIORITY
1978/07/27 SUPPL-1(补充) Approval Manufacturing (CMC) PRIORITY
1973/05/15 ORIG-1(原始申请) Approval Type 5 - New Formulation or New Manufacturer 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
本品无治疗等效药品
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