药品注册申请号:080704
申请类型:ANDA (仿制药申请)
申请人:BIONPHARMA
申请人全名:BIONPHARMA 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 VITAMIN D ERGOCALCIFEROL CAPSULE;ORAL 50,000 IU No No AA 1978/10/16 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
2008/07/24 SUPPL-43(补充) Approval Labeling
2001/10/24 SUPPL-41(补充) Approval Labeling
2001/10/24 SUPPL-40(补充) Approval Manufacturing (CMC)
2001/10/24 SUPPL-39(补充) Approval Manufacturing (CMC)
2001/10/24 SUPPL-38(补充) Approval Manufacturing (CMC)
2001/10/24 SUPPL-37(补充) Approval Manufacturing (CMC)
1998/09/09 SUPPL-36(补充) Approval Manufacturing (CMC)
1997/01/16 SUPPL-30(补充) Approval Manufacturing (CMC)
1996/08/28 SUPPL-34(补充) Approval Manufacturing (CMC)
1996/08/28 SUPPL-33(补充) Approval Manufacturing (CMC)
1996/08/28 SUPPL-32(补充) Approval Manufacturing (CMC)
1995/05/31 SUPPL-31(补充) Approval Manufacturing (CMC)
1995/01/24 SUPPL-29(补充) Approval Manufacturing (CMC)
1995/01/24 SUPPL-28(补充) Approval Manufacturing (CMC)
1989/03/24 SUPPL-27(补充) Approval Labeling
1985/03/22 SUPPL-23(补充) Approval Manufacturing (CMC)
1985/03/22 SUPPL-22(补充) Approval Manufacturing (CMC)
1985/03/22 SUPPL-21(补充) Approval Manufacturing (CMC)
1985/03/22 SUPPL-20(补充) Approval Manufacturing (CMC)
1985/03/22 SUPPL-19(补充) Approval Manufacturing (CMC)
1985/03/22 SUPPL-18(补充) Approval Manufacturing (CMC)
1985/03/22 SUPPL-17(补充) Approval Manufacturing (CMC)
1985/03/22 SUPPL-16(补充) Approval Manufacturing (CMC)
1985/03/22 SUPPL-15(补充) Approval Manufacturing (CMC)
1984/03/08 SUPPL-12(补充) Approval Manufacturing (CMC)
1978/10/16 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)
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:ERGOCALCIFEROL 剂型/给药途径:CAPSULE;ORAL 规格:50,000 IU 治疗等效代码:AA
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
003444 001 NDA DRISDOL ERGOCALCIFEROL CAPSULE;ORAL 50,000 IU Prescription Yes No AA Approved Prior to Jan 1, 1982 SS PHARMA
080704 001 ANDA VITAMIN D ERGOCALCIFEROL CAPSULE;ORAL 50,000 IU Prescription No No AA Approved Prior to Jan 1, 1982 BIONPHARMA
040833 001 ANDA ERGOCALCIFEROL ERGOCALCIFEROL CAPSULE;ORAL 50,000 IU Prescription No No AA 2009/05/20 CHARTWELL RX
040865 001 ANDA ERGOCALCIFEROL ERGOCALCIFEROL CAPSULE;ORAL 50,000 IU Discontinued No No AA 2009/12/29 SUN PHARM INDS INC
090455 001 ANDA ERGOCALCIFEROL ERGOCALCIFEROL CAPSULE;ORAL 50,000 IU Prescription No Yes AA 2010/08/03 STRIDES PHARMA
204276 001 ANDA ERGOCALCIFEROL ERGOCALCIFEROL CAPSULE;ORAL 50,000 IU Prescription No No AA 2018/12/07 PURACAP PHARM LLC
更多信息
药品NDC数据与药品包装、标签说明书
©2006-2024 DrugFuture->U.S. FDA Drugs Database