药品注册申请号:008306
申请类型:NDA (新药申请)
申请人:ANI PHARMS
申请人全名:ANI 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
004 PHENERGAN W/ CODEINE CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE SYRUP;ORAL 10MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1952/01/21 1984/04/02 Discontinued
005 PHENERGAN VC W/ CODEINE CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE SYRUP;ORAL 10MG/5ML;5MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1984/04/02 Discontinued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
2023/12/15 SUPPL-35(补充) Approval Labeling STANDARD
2018/06/28 SUPPL-34(补充) Approval Labeling STANDARD
2017/08/29 SUPPL-33(补充) Approval Labeling STANDARD
2017/01/13 SUPPL-32(补充) Approval Labeling STANDARD
2013/05/09 SUPPL-31(补充) Approval Labeling 901 REQUIRED
2008/11/26 SUPPL-30(补充) Approval Labeling STANDARD
2001/02/23 SUPPL-29(补充) Approval Labeling STANDARD
2000/06/23 SUPPL-27(补充) Approval Manufacturing (CMC) STANDARD
1998/05/06 SUPPL-25(补充) Approval Manufacturing (CMC) STANDARD
1998/02/10 SUPPL-24(补充) Approval Manufacturing (CMC) STANDARD
1992/03/30 SUPPL-22(补充) Approval Manufacturing (CMC) STANDARD
1989/12/12 SUPPL-21(补充) Approval Manufacturing (CMC) STANDARD
1989/12/12 SUPPL-20(补充) Approval Manufacturing (CMC) STANDARD
1989/01/11 SUPPL-19(补充) Approval Labeling
1988/06/30 SUPPL-18(补充) Approval Manufacturing (CMC) STANDARD
1987/04/13 SUPPL-14(补充) Approval Manufacturing (CMC) STANDARD
1986/05/29 SUPPL-13(补充) Approval Manufacturing (CMC) STANDARD
1985/11/04 SUPPL-16(补充) Approval Labeling
1985/07/29 SUPPL-15(补充) Approval Manufacturing (CMC) STANDARD
1984/04/12 SUPPL-12(补充) Approval Labeling
1984/04/02 SUPPL-11(补充) Approval Efficacy
1984/04/02 SUPPL-10(补充) Approval Manufacturing (CMC) STANDARD
1952/01/21 ORIG-1(原始申请) Approval Type 4 - New Combination STANDARD
与本品相关的专利信息(来自FDA橙皮书Orange Book)
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与本品相关的市场独占权保护信息
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与本品治疗等效的药品
本品无治疗等效药品
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