药品注册申请号：214309
申请类型：ANDA (仿制药申请)
申请人：HIKMA
申请人全名：HIKMA PHARMACEUTICALS 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
001 MEDROXYPROGESTERONE ACETATE MEDROXYPROGESTERONE ACETATE INJECTABLE;INJECTION 150MG/ML No No AB 2023/01/05 2023/01/05 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
2023/01/05 ORIG-1（原始申请） Approval STANDARD
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
无
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
无
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 PFIZER
076553 001 ANDA MEDROXYPROGESTERONE ACETATE MEDROXYPROGESTERONE ACETATE INJECTABLE;INJECTION 150MG/ML Prescription No No AB 2004/07/28 HONG KONG
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 XIROMED
210761 001 ANDA MEDROXYPROGESTERONE ACETATE MEDROXYPROGESTERONE ACETATE INJECTABLE;INJECTION 150MG/ML Discontinued No No AB 2019/04/24 SUN PHARM
210760 001 ANDA MEDROXYPROGESTERONE ACETATE MEDROXYPROGESTERONE ACETATE INJECTABLE;INJECTION 150MG/ML Discontinued No No AB 2019/05/01 SUN PHARM
212824 001 ANDA MEDROXYPROGESTERONE ACETATE MEDROXYPROGESTERONE ACETATE INJECTABLE;INJECTION 150MG/ML Prescription No No AB 2022/08/22 EUGIA PHARMA
212844 001 ANDA MEDROXYPROGESTERONE ACETATE MEDROXYPROGESTERONE ACETATE INJECTABLE;INJECTION 150MG/ML Prescription No No AB 2022/08/31 EUGIA PHARMA
214309 001 ANDA MEDROXYPROGESTERONE ACETATE MEDROXYPROGESTERONE ACETATE INJECTABLE;INJECTION 150MG/ML Discontinued No No AB 2023/01/05 HIKMA
215397 001 ANDA MEDROXYPROGESTERONE ACETATE MEDROXYPROGESTERONE ACETATE INJECTABLE;INJECTION 150MG/ML Prescription No No AB 2023/06/07 AMNEAL
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
©2006-2024 DrugFuture->U.S. FDA Drugs Database