药品注册申请号:020246
申请类型:NDA (新药申请)
申请人:PHARMACIA AND UPJOHN
申请人全名:PHARMACIA AND UPJOHN CO
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 DEPO-PROVERA MEDROXYPROGESTERONE ACETATE INJECTABLE;INJECTION 150MG/ML Yes Yes AB 1992/10/29 1992/10/29 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
2017/03/16 SUPPL 63 Approval Labeling STANDARD
2016/12/16 SUPPL 58 Approval Labeling STANDARD
2016/02/24 SUPPL 40 Approval Manufacturing (CMC) PRIORITY
2015/01/30 SUPPL 53 Approval Labeling STANDARD
2015/01/23 SUPPL 54 Approval Labeling STANDARD
2014/06/09 SUPPL 52 Approval Manufacturing (CMC) PRIORITY
2013/09/27 SUPPL 50 Approval Manufacturing (CMC) PRIORITY
2013/09/10 SUPPL 49 Approval Manufacturing (CMC) PRIORITY
2013/03/25 SUPPL 48 Approval Manufacturing (CMC) PRIORITY
2011/07/28 SUPPL 35 Approval Efficacy STANDARD
2010/10/15 SUPPL 36 Approval Efficacy STANDARD
2005/10/28 SUPPL 13 Approval Labeling STANDARD
2004/11/17 SUPPL 25 Approval Labeling STANDARD
2003/05/23 SUPPL 19 Approval Manufacturing (CMC) PRIORITY
2002/05/23 SUPPL 18 Approval Manufacturing (CMC) PRIORITY
2002/04/26 SUPPL 17 Approval Manufacturing (CMC) PRIORITY
2001/06/07 SUPPL 15 Approval Manufacturing (CMC) PRIORITY
2000/04/03 SUPPL 14 Approval Manufacturing (CMC) PRIORITY
1998/08/12 SUPPL 12 Approval Labeling STANDARD
1997/01/31 SUPPL 11 Approval Labeling STANDARD
1996/03/20 SUPPL 9 Approval Labeling STANDARD
1996/02/01 SUPPL 6 Approval Manufacturing (CMC) PRIORITY
1995/11/28 SUPPL 8 Approval Manufacturing (CMC) PRIORITY
1995/05/03 SUPPL 7 Approval Manufacturing (CMC) PRIORITY
1994/12/01 SUPPL 4 Approval Labeling STANDARD
1994/12/01 SUPPL 3 Approval Labeling STANDARD
1994/02/17 SUPPL 2 Approval Manufacturing (CMC) PRIORITY
1992/10/29 ORIG 1 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
活性成分:MEDROXYPROGESTERONE ACETATE 剂型/给药途径:INJECTABLE;INJECTION 规格:150MG/ML 治疗等效代码:AB
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
020246 001 NDA DEPO-PROVERA MEDROXYPROGESTERONE ACETATE INJECTABLE;INJECTION 150MG/ML Prescription Yes Yes AB 1992/10/29 PHARMACIA AND UPJOHN
076553 001 ANDA MEDROXYPROGESTERONE ACETATE MEDROXYPROGESTERONE ACETATE INJECTABLE;INJECTION 150MG/ML Prescription No No AB 2004/07/28 TEVA PHARMS USA
077235 001 ANDA MEDROXYPROGESTERONE ACETATE MEDROXYPROGESTERONE ACETATE INJECTABLE;INJECTION 150MG/ML Prescription No No AB 2017/11/28 AMPHASTAR PHARMS INC
077334 001 ANDA MEDROXYPROGESTERONE ACETATE MEDROXYPROGESTERONE ACETATE INJECTABLE;INJECTION 150MG/ML Prescription No No AB 2017/11/28 AMPHASTAR PHARMS INC
210227 001 ANDA MEDROXYPROGESTERONE ACETATE MEDROXYPROGESTERONE ACETATE INJECTABLE;INJECTION 150MG/ML Prescription No No AB 2018/10/12 MYLAN LABS LTD
210761 001 ANDA MEDROXYPROGESTERONE ACETATE MEDROXYPROGESTERONE ACETATE INJECTABLE;INJECTION 150MG/ML Prescription No No AB 2019/04/24 SUN PHARM
210760 001 ANDA MEDROXYPROGESTERONE ACETATE MEDROXYPROGESTERONE ACETATE INJECTABLE;INJECTION 150MG/ML Prescription No No AB 2019/05/01 SUN PHARM
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