药品注册申请号:074888
申请类型:ANDA (仿制药申请)
申请人:MEITHEAL
申请人全名:MEITHEAL PHARMACEUTICALS 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 DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE INJECTABLE;INJECTION 0.004MG/ML No No AP 1997/10/15 1997/10/15 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
2019/07/25 SUPPL-27(补充) Approval Labeling STANDARD
2019/07/25 SUPPL-26(补充) Approval Labeling STANDARD
2009/03/27 SUPPL-9(补充) Approval Labeling
2002/03/25 SUPPL-2(补充) Approval Labeling
1998/08/10 SUPPL-1(补充) Approval Manufacturing (CMC)
1997/10/15 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:DESMOPRESSIN ACETATE 剂型/给药途径:INJECTABLE;INJECTION 规格:0.004MG/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
018938 001 NDA DDAVP DESMOPRESSIN ACETATE INJECTABLE;INJECTION 0.004MG/ML Prescription Yes Yes AP 1984/03/30 FERRING PHARMS INC
074888 001 ANDA DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE INJECTABLE;INJECTION 0.004MG/ML Prescription No No AP 1997/10/15 MEITHEAL
091280 001 ANDA DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE INJECTABLE;INJECTION 0.004MG/ML Prescription No No AP 2013/01/25 SUN PHARM INDS LTD
204695 001 ANDA DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE INJECTABLE;INJECTION 0.004MG/ML Prescription No No AP 2017/08/22 SAGENT PHARMS INC
204751 001 ANDA DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE INJECTABLE;INJECTION 0.004MG/ML Prescription No No AP 2017/08/22 SAGENT PHARMS INC
091374 001 ANDA DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE INJECTABLE;INJECTION 0.004MG/ML Discontinued No No AP 2019/02/14 AM REGENT
210218 001 ANDA DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE INJECTABLE;INJECTION 0.004MG/ML Prescription No No AP 2020/02/14 UBI
210223 001 ANDA DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE INJECTABLE;INJECTION 0.004MG/ML Prescription No No AP 2020/09/17 UBI
215961 001 ANDA DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE INJECTABLE;INJECTION 0.004MG/ML Prescription No No AP 2022/08/19 DR REDDYS
216922 001 ANDA DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE INJECTABLE;INJECTION 0.004MG/ML Prescription No No AP 2022/11/16 GLAND PHARMA LTD
216904 001 ANDA DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE INJECTABLE;INJECTION 0.004MG/ML Prescription No No AP 2023/03/20 GLAND
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