药品注册申请号:088875
申请类型:ANDA (仿制药申请)
申请人:WOCKHARDT BIO AG
申请人全名:WOCKHARDT BIO AG
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 PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE SYRUP;ORAL 10MG/5ML;6.25MG/5ML No No AA 1984/12/17 1984/12/17 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
2018/06/28 SUPPL-39(补充) Approval Labeling STANDARD
2017/11/17 SUPPL-38(补充) Approval Labeling STANDARD
2017/01/13 SUPPL-37(补充) Approval Labeling STANDARD
2015/10/29 SUPPL-34(补充) Approval Manufacturing (CMC) UNKNOWN
2013/05/10 SUPPL-35(补充) Approval Labeling STANDARD
2010/01/21 SUPPL-32(补充) Approval Labeling
2008/12/19 SUPPL-31(补充) Approval Labeling
2008/02/25 SUPPL-30(补充) Approval Labeling
2006/04/03 SUPPL-29(补充) Approval Labeling
2002/06/27 SUPPL-26(补充) Approval Labeling
2002/06/27 SUPPL-25(补充) Approval Manufacturing (CMC)
2002/06/27 SUPPL-24(补充) Approval Manufacturing (CMC)
1991/01/18 SUPPL-17(补充) Approval Labeling
1990/08/23 SUPPL-16(补充) Approval Labeling
1990/01/31 SUPPL-15(补充) Approval Labeling
1989/04/05 SUPPL-14(补充) Approval Manufacturing (CMC)
1988/08/08 SUPPL-13(补充) Approval Manufacturing (CMC)
1987/04/07 SUPPL-8(补充) Approval Manufacturing (CMC)
1987/04/07 SUPPL-7(补充) Approval Manufacturing (CMC)
1987/04/07 SUPPL-6(补充) Approval Manufacturing (CMC)
1987/04/07 SUPPL-5(补充) Approval Manufacturing (CMC)
1987/04/07 SUPPL-4(补充) Approval Manufacturing (CMC)
1986/03/05 SUPPL-2(补充) Approval Manufacturing (CMC)
1986/03/05 SUPPL-1(补充) Approval Manufacturing (CMC)
1984/12/17 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:CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 剂型/给药途径:SYRUP;ORAL 规格:10MG/5ML;6.25MG/5ML 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
088763 001 ANDA PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE SYRUP;ORAL 10MG/5ML;6.25MG/5ML Discontinued Yes No AA 1984/10/31 ACTAVIS MID ATLANTIC
088875 001 ANDA PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE SYRUP;ORAL 10MG/5ML;6.25MG/5ML Prescription No No AA 1984/12/17 WOCKHARDT BIO AG
040151 001 ANDA PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE SYRUP;ORAL 10MG/5ML;6.25MG/5ML Discontinued No No AA 1997/08/26 HIKMA
040650 001 ANDA PROMETHAZINE WITH CODEINE CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE SYRUP;ORAL 10MG/5ML;6.25MG/5ML Prescription No No AA 2006/01/31 PHARM ASSOC
090180 001 ANDA PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE SYRUP;ORAL 10MG/5ML;6.25MG/5ML Prescription No No AA 2010/03/17 NOSTRUM LABS INC
200386 001 ANDA PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE SYRUP;ORAL 10MG/5ML;6.25MG/5ML Prescription No Yes AA 2012/06/29 TRIS PHARMA INC
200894 001 ANDA PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE SYRUP;ORAL 10MG/5ML;6.25MG/5ML Prescription No No AA 2013/04/24 AMNEAL PHARMS
214238 001 ANDA PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE SYRUP;ORAL 10MG/5ML;6.25MG/5ML Prescription No No AA 2020/10/08 QUAGEN
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