药品注册申请号:080737
申请类型:ANDA (仿制药申请)
申请人:AM REGENT
申请人全名:AMERICAN REGENT 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 CYANOCOBALAMIN CYANOCOBALAMIN INJECTABLE;INJECTION 1MG/ML Yes Yes AP 1972/04/26 Approved Prior to Jan 1, 1982 Prescription
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2002/06/27 SUPPL 23 Approval Manufacturing (CMC)
2002/06/27 SUPPL 22 Approval Manufacturing (CMC)
2001/05/14 SUPPL 21 Approval Labeling
2001/05/14 SUPPL 20 Approval Manufacturing (CMC)
2001/02/21 SUPPL 19 Approval Manufacturing (CMC)
2000/09/11 SUPPL 17 Approval Manufacturing (CMC)
1999/11/19 SUPPL 18 Approval Manufacturing (CMC)
1997/10/30 SUPPL 16 Approval Manufacturing (CMC)
1996/09/17 SUPPL 15 Approval Labeling
1996/09/17 SUPPL 14 Approval Manufacturing (CMC)
1996/02/28 SUPPL 13 Approval Manufacturing (CMC)
1992/07/29 SUPPL 11 Approval Manufacturing (CMC)
1992/07/29 SUPPL 10 Approval Manufacturing (CMC)
1989/11/28 SUPPL 12 Approval Labeling
1988/10/20 SUPPL 9 Approval Labeling
1988/10/20 SUPPL 5 Approval Labeling
1986/01/17 SUPPL 8 Approval Manufacturing (CMC)
1986/01/17 SUPPL 7 Approval Manufacturing (CMC)
1986/01/17 SUPPL 6 Approval Manufacturing (CMC)
1982/08/16 SUPPL 3 Approval Manufacturing (CMC)
1972/04/26 ORIG 1 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:CYANOCOBALAMIN 剂型/给药途径:INJECTABLE;INJECTION 规格:1MG/ML 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
080515 002 ANDA CYANOCOBALAMIN CYANOCOBALAMIN INJECTABLE;INJECTION 1MG/ML Prescription No No AP Approved Prior to Jan 1, 1982 WEST-WARD PHARMS INT
080557 003 ANDA VIBISONE CYANOCOBALAMIN INJECTABLE;INJECTION 1MG/ML Prescription No Yes AP Approved Prior to Jan 1, 1982 FRESENIUS KABI USA
080737 001 ANDA CYANOCOBALAMIN CYANOCOBALAMIN INJECTABLE;INJECTION 1MG/ML Prescription Yes Yes AP Approved Prior to Jan 1, 1982 AM REGENT
206503 001 ANDA CYANOCOBALAMIN CYANOCOBALAMIN INJECTABLE;INJECTION 1MG/ML Prescription No No AP 2015/12/11 SOMERSET THERAPS LLC
204829 001 ANDA CYANOCOBALAMIN CYANOCOBALAMIN INJECTABLE;INJECTION 1MG/ML Prescription No No AP 2017/06/05 MYLAN LABS LTD
209255 001 ANDA CYANOCOBALAMIN CYANOCOBALAMIN INJECTABLE;INJECTION 1MG/ML Prescription No No AP 2018/12/18 VITRUVIAS THERAP
209429 001 ANDA CYANOCOBALAMIN CYANOCOBALAMIN INJECTABLE;INJECTION 1MG/ML Prescription No No AP 2018/12/18 SOMERSET THERAPS LLC
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