药品注册申请号:018604
申请类型:NDA (新药申请)
申请人:BAUSCH
申请人全名:BAUSCH HEALTH US 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 OINTMENT;TOPICAL 5% Yes Yes AB 1982/03/29 1982/03/29 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
2014/09/29 SUPPL-25(补充) Approval Manufacturing (CMC) PRIORITY
2002/11/22 SUPPL-19(补充) Approval Manufacturing (CMC) PRIORITY
2001/05/30 SUPPL-18(补充) Approval Labeling STANDARD
2001/05/30 SUPPL-16(补充) Approval Labeling STANDARD
2000/07/12 SUPPL-17(补充) Approval Manufacturing (CMC) PRIORITY
1999/02/03 SUPPL-15(补充) Approval Manufacturing (CMC) PRIORITY
1997/01/08 SUPPL-14(补充) Approval Labeling STANDARD
1996/10/29 SUPPL-13(补充) Approval Manufacturing (CMC) PRIORITY
1993/11/09 SUPPL-11(补充) Approval Manufacturing (CMC) PRIORITY
1993/01/21 SUPPL-10(补充) Approval Labeling
1993/01/21 SUPPL-8(补充) Approval Labeling
1992/07/23 SUPPL-9(补充) Approval Manufacturing (CMC) PRIORITY
1986/11/12 SUPPL-7(补充) Approval Manufacturing (CMC) PRIORITY
1985/04/02 SUPPL-6(补充) Approval Manufacturing (CMC) PRIORITY
1982/12/16 SUPPL-4(补充) Approval Labeling
1982/07/21 SUPPL-3(补充) Approval Manufacturing (CMC) PRIORITY
1982/06/14 SUPPL-2(补充) Approval Manufacturing (CMC) PRIORITY
1982/03/29 ORIG-1(原始申请) Approval Type 1 - New Molecular Entity PRIORITY
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:OINTMENT;TOPICAL 规格:5% 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
018604 001 NDA ZOVIRAX ACYCLOVIR OINTMENT;TOPICAL 5% Prescription Yes Yes AB 1982/03/29 BAUSCH
202459 001 ANDA ACYCLOVIR ACYCLOVIR OINTMENT;TOPICAL 5% Prescription No No AB 2013/04/03 MYLAN PHARMS INC
204605 001 ANDA ACYCLOVIR ACYCLOVIR OINTMENT;TOPICAL 5% Prescription No No AB 2014/06/18 AMNEAL PHARMS
206633 001 ANDA ACYCLOVIR ACYCLOVIR OINTMENT;TOPICAL 5% Prescription No No AB 2016/05/11 FOUGERA PHARMS INC
205469 001 ANDA ACYCLOVIR ACYCLOVIR OINTMENT;TOPICAL 5% Prescription No No AB 2016/12/21 TARO
205510 001 ANDA ACYCLOVIR ACYCLOVIR OINTMENT;TOPICAL 5% Prescription No No AB 2017/07/31 GLENMARK SPECLT
205591 001 ANDA ACYCLOVIR ACYCLOVIR OINTMENT;TOPICAL 5% Discontinued No No AB 2017/11/13 COSETTE
209000 001 ANDA ACYCLOVIR ACYCLOVIR OINTMENT;TOPICAL 5% Prescription No No AB 2018/04/06 ALEMBIC
209971 001 ANDA ACYCLOVIR ACYCLOVIR OINTMENT;TOPICAL 5% Prescription No No AB 2019/01/11 TORRENT
211794 001 ANDA ACYCLOVIR ACYCLOVIR OINTMENT;TOPICAL 5% Prescription No No AB 2019/01/18 CIPLA
205974 001 ANDA ACYCLOVIR ACYCLOVIR OINTMENT;TOPICAL 5% Prescription No No AB 2019/03/15 ZYDUS LIFESCIENCES
210774 001 ANDA ACYCLOVIR ACYCLOVIR OINTMENT;TOPICAL 5% Prescription No No AB 2019/09/06 APOTEX
201501 001 ANDA ACYCLOVIR ACYCLOVIR OINTMENT;TOPICAL 5% Prescription No No AB 2020/01/29 XIROMED
212495 001 ANDA ACYCLOVIR ACYCLOVIR OINTMENT;TOPICAL 5% Prescription No No AB 2020/04/07 CHARTWELL RX
212444 001 ANDA ACYCLOVIR ACYCLOVIR OINTMENT;TOPICAL 5% Prescription No No AB 2021/05/19 MACLEODS PHARMS LTD
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