药品注册申请号:019909
申请类型:NDA (新药申请)
申请人:NORVIUM BIOSCIENCE
申请人全名:NORVIUM BIOSCIENCE LLC
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 ZOVIRAX ACYCLOVIR SUSPENSION;ORAL 200MG/5ML Yes No AB 1989/12/22 1989/12/22 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
2016/04/18 SUPPL-23(补充) Approval Manufacturing (CMC) STANDARD
2008/08/08 SUPPL-22(补充) Approval Labeling STANDARD
2005/12/09 SUPPL-20(补充) Approval Labeling STANDARD
2004/05/19 SUPPL-19(补充) Approval Labeling STANDARD
2001/11/14 SUPPL-17(补充) Approval Labeling STANDARD
2001/11/14 SUPPL-16(补充) Approval Labeling STANDARD
2000/07/12 SUPPL-15(补充) Approval Manufacturing (CMC) STANDARD
2000/03/15 SUPPL-14(补充) Approval Labeling STANDARD
1998/02/25 SUPPL-13(补充) Approval Manufacturing (CMC) STANDARD
1997/05/29 SUPPL-12(补充) Approval Labeling STANDARD
1997/01/08 SUPPL-11(补充) Approval Labeling STANDARD
1996/10/29 SUPPL-10(补充) Approval Manufacturing (CMC) STANDARD
1995/04/12 SUPPL-8(补充) Approval Labeling STANDARD
1994/04/14 SUPPL-6(补充) Approval Labeling STANDARD
1993/11/09 SUPPL-5(补充) Approval Manufacturing (CMC) STANDARD
1993/04/22 SUPPL-4(补充) Approval Labeling
1992/02/26 SUPPL-3(补充) Approval Efficacy
1991/04/30 SUPPL-2(补充) Approval Labeling
1990/04/26 SUPPL-1(补充) Approval Labeling
1989/12/22 ORIG-1(原始申请) Approval Type 3 - New Dosage Form 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
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:ACYCLOVIR 剂型/给药途径:SUSPENSION;ORAL 规格:200MG/5ML 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
019909 001 NDA ZOVIRAX ACYCLOVIR SUSPENSION;ORAL 200MG/5ML Discontinued Yes No AB 1989/12/22 NORVIUM BIOSCIENCE
074738 001 ANDA ACYCLOVIR ACYCLOVIR SUSPENSION;ORAL 200MG/5ML Prescription No No AB 1997/04/28 ACTAVIS MID ATLANTIC
077026 001 ANDA ACYCLOVIR ACYCLOVIR SUSPENSION;ORAL 200MG/5ML Discontinued No No AB 2005/06/07 HIKMA
212718 001 ANDA ACYCLOVIR ACYCLOVIR SUSPENSION;ORAL 200MG/5ML Prescription No No AB 2020/04/23 CHARTWELL RX
212252 001 ANDA ACYCLOVIR ACYCLOVIR SUSPENSION;ORAL 200MG/5ML Prescription No Yes AB 2020/07/10 NOVITIUM PHARMA
216331 001 ANDA ACYCLOVIR ACYCLOVIR SUSPENSION;ORAL 200MG/5ML Prescription No No AB 2022/03/31 AUROBINDO PHARMA
215669 001 ANDA ACYCLOVIR ACYCLOVIR SUSPENSION;ORAL 200MG/5ML Prescription No No AB 2022/07/01 HETERO LABS LTD III
215724 001 ANDA ACYCLOVIR ACYCLOVIR SUSPENSION;ORAL 200MG/5ML Prescription No No AB 2022/08/18 RUBICON
217393 001 ANDA ACYCLOVIR ACYCLOVIR SUSPENSION;ORAL 200MG/5ML Prescription No No AB 2023/03/09 MSN
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