药品注册申请号:019510
申请类型:NDA (新药申请)
申请人:MERCK
申请人全名:MERCK RESEARCH LABORATORIES DIV MERCK CO 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 PEPCID FAMOTIDINE INJECTABLE;INJECTION 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1986/11/04 1986/11/04 Discontinued
004 PEPCID PRESERVATIVE FREE FAMOTIDINE INJECTABLE;INJECTION 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1986/11/04 Discontinued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
2007/11/05 SUPPL-31(补充) Approval Labeling STANDARD
2002/08/01 SUPPL-30(补充) Approval Manufacturing (CMC) STANDARD
2002/06/06 SUPPL-28(补充) Approval Efficacy STANDARD
2001/04/25 SUPPL-27(补充) Approval Labeling STANDARD
2001/03/14 SUPPL-29(补充) Approval Labeling STANDARD
1999/05/06 SUPPL-21(补充) Approval Manufacturing (CMC) STANDARD
1999/03/18 SUPPL-26(补充) Approval Labeling STANDARD
1999/01/28 SUPPL-25(补充) Approval Labeling STANDARD
1998/08/12 SUPPL-20(补充) Approval Labeling STANDARD
1997/12/19 SUPPL-24(补充) Approval Manufacturing (CMC) STANDARD
1997/11/12 SUPPL-23(补充) Approval Labeling STANDARD
1997/05/16 SUPPL-22(补充) Approval Labeling STANDARD
1997/05/16 SUPPL-11(补充) Approval Labeling
1996/05/08 SUPPL-15(补充) Approval Manufacturing (CMC) STANDARD
1996/01/30 SUPPL-19(补充) Approval Manufacturing (CMC) STANDARD
1995/06/29 SUPPL-18(补充) Approval Labeling STANDARD
1995/06/29 SUPPL-17(补充) Approval Labeling STANDARD
1995/06/29 SUPPL-16(补充) Approval Labeling STANDARD
1995/06/29 SUPPL-9(补充) Approval Labeling
1992/01/07 SUPPL-5(补充) Approval Manufacturing (CMC) STANDARD
1991/12/10 SUPPL-10(补充) Approval Labeling
1990/11/30 SUPPL-12(补充) Approval Labeling
1990/11/30 SUPPL-8(补充) Approval Labeling
1990/11/30 SUPPL-7(补充) Approval Labeling
1988/11/23 SUPPL-4(补充) Approval Labeling
1988/10/28 SUPPL-6(补充) Approval Labeling
1987/06/03 SUPPL-3(补充) Approval Manufacturing (CMC) STANDARD
1987/04/01 SUPPL-2(补充) Approval Labeling
1986/12/12 SUPPL-1(补充) Approval Labeling
1986/11/04 ORIG-1(原始申请) 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)
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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
与本品治疗等效的药品
本品无治疗等效药品
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