药品注册申请号:085311
申请类型:ANDA (仿制药申请)
申请人:FOSUN PHARMA
申请人全名:FOSUN PHARMA USA 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
002 LONOX ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE TABLET;ORAL 0.025MG;2.5MG No No None 1977/06/07 Approved Prior to Jan 1, 1982 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
2000/11/28 SUPPL-72(补充) Approval Manufacturing (CMC)
2000/08/24 SUPPL-71(补充) Approval Manufacturing (CMC)
1999/08/04 SUPPL-67(补充) Approval Labeling
1999/08/04 SUPPL-66(补充) Approval Manufacturing (CMC)
1999/05/05 SUPPL-69(补充) Approval Manufacturing (CMC)
1998/11/23 SUPPL-68(补充) Approval Manufacturing (CMC)
1998/06/08 SUPPL-65(补充) Approval Manufacturing (CMC)
1998/01/29 SUPPL-64(补充) Approval Manufacturing (CMC)
1991/06/26 SUPPL-63(补充) Approval Labeling
1989/12/19 SUPPL-62(补充) Approval Labeling
1989/08/09 SUPPL-61(补充) Approval Labeling
1988/12/09 SUPPL-60(补充) Approval Labeling
1988/04/19 SUPPL-59(补充) Approval Labeling
1985/10/28 SUPPL-52(补充) Approval Manufacturing (CMC)
1985/01/23 SUPPL-53(补充) Approval Manufacturing (CMC)
1983/06/17 SUPPL-51(补充) Approval Manufacturing (CMC)
1983/04/22 SUPPL-50(补充) Approval Manufacturing (CMC)
1983/04/22 SUPPL-49(补充) Approval Manufacturing (CMC)
1982/11/16 SUPPL-47(补充) Approval Manufacturing (CMC)
1982/10/15 SUPPL-46(补充) Approval Manufacturing (CMC)
1982/07/29 SUPPL-44(补充) Approval Manufacturing (CMC)
1982/07/29 SUPPL-43(补充) Approval Manufacturing (CMC)
1982/05/13 SUPPL-40(补充) Approval Manufacturing (CMC)
1982/05/13 SUPPL-39(补充) Approval Manufacturing (CMC)
1982/05/13 SUPPL-38(补充) Approval Manufacturing (CMC)
1977/06/07 ORIG-1(原始申请) Approval
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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