药品注册申请号:022410
申请类型:NDA (新药申请)
申请人:INDIVIOR
申请人全名:INDIVIOR 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 SUBOXONE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE FILM;BUCCAL, SUBLINGUAL EQ 2MG BASE;EQ 0.5MG BASE Yes No AB 2010/08/30 2010/08/30 Prescription
002 SUBOXONE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE FILM;BUCCAL, SUBLINGUAL EQ 8MG BASE;EQ 2MG BASE Yes No AB 2010/08/30 Prescription
003 SUBOXONE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE FILM;BUCCAL, SUBLINGUAL EQ 4MG BASE;EQ 1MG BASE Yes No AB 2012/08/10 Prescription
004 SUBOXONE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE FILM;BUCCAL, SUBLINGUAL EQ 12MG BASE;EQ 3MG BASE Yes Yes AB 2012/08/10 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
2024/03/20 SUPPL-50(补充) Approval REMS N/A
2023/12/15 SUPPL-52(补充) Approval Labeling STANDARD
2023/03/13 SUPPL-49(补充) Approval Labeling STANDARD
2022/12/16 SUPPL-48(补充) Approval REMS N/A
2022/06/17 SUPPL-47(补充) Approval Labeling STANDARD
2022/06/17 SUPPL-46(补充) Approval Labeling STANDARD
2022/05/03 SUPPL-45(补充) Approval REMS N/A
2021/11/19 SUPPL-44(补充) Approval REMS N/A
2021/03/04 SUPPL-42(补充) Approval Labeling STANDARD
2020/03/02 SUPPL-39(补充) Approval REMS N/A ;Orphan
2019/10/31 SUPPL-34(补充) Approval Labeling STANDARD ;Orphan
2019/10/07 SUPPL-38(补充) Approval Labeling STANDARD ;Orphan
2018/10/26 SUPPL-35(补充) Approval REMS N/A ;Orphan
2018/06/11 SUPPL-33(补充) Approval REMS N/A ;Orphan
2018/02/01 SUPPL-31(补充) Approval Labeling STANDARD ;Orphan
2017/09/19 SUPPL-30(补充) Approval REMS N/A ;Orphan
2017/09/19 SUPPL-29(补充) Approval REMS STANDARD
2017/02/13 SUPPL-23(补充) Approval Efficacy STANDARD
2017/01/12 SUPPL-28(补充) Approval Manufacturing (CMC) STANDARD
2016/12/16 SUPPL-27(补充) Approval Labeling STANDARD
2016/12/16 SUPPL-26(补充) Approval Labeling STANDARD
2016/07/07 SUPPL-25(补充) Approval REMS N/A
2016/04/15 SUPPL-24(补充) Approval Manufacturing (CMC) STANDARD
2015/09/22 SUPPL-22(补充) Approval REMS N/A
2015/09/22 SUPPL-20(补充) Approval Efficacy STANDARD ;Orphan
2015/06/23 SUPPL-21(补充) Approval Manufacturing (CMC) STANDARD
2014/08/12 SUPPL-19(补充) Approval Manufacturing (CMC) STANDARD
2014/06/05 SUPPL-16(补充) Approval Manufacturing (CMC) STANDARD
2014/04/28 SUPPL-18(补充) Approval Efficacy STANDARD
2014/04/28 SUPPL-17(补充) Approval Labeling UNKNOWN
2014/04/28 SUPPL-4(补充) Approval Efficacy STANDARD
2014/03/12 SUPPL-14(补充) Approval Manufacturing (CMC) STANDARD
2013/11/22 SUPPL-15(补充) Approval Labeling STANDARD
2013/08/08 SUPPL-11(补充) Approval Manufacturing (CMC) STANDARD
2012/08/10 SUPPL-7(补充) Approval Manufacturing (CMC) STANDARD
2012/08/10 SUPPL-6(补充) Approval Manufacturing (CMC) STANDARD
2010/08/30 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)
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
001 11135216 2029/08/07 Y U-3111 2021/10/21 PDF格式
8475832 2030/03/26 Y U-1411 2013/07/03 PDF格式
8603514 2024/04/03 Y U-1464 PDF格式
9687454 2029/08/07 Y U-1464 2017/07/14 PDF格式
002 11135216 2029/08/07 Y U-3111 2021/10/21 PDF格式
8475832 2030/03/26 Y U-1411 PDF格式
8603514 2024/04/03 Y U-1464 PDF格式
9687454 2029/08/07 Y U-1464 2017/07/14 PDF格式
003 11135216 2029/08/07 Y U-3111 2021/10/21 PDF格式
8475832 2030/03/26 Y U-1411 PDF格式
8603514 2024/04/03 Y U-1464 PDF格式
9687454 2029/08/07 Y U-1464 2017/07/14 PDF格式
004 11135216 2029/08/07 Y U-3111 2021/10/21 PDF格式
8475832 2030/03/26 Y U-1411 PDF格式
8603514 2024/04/03 Y U-1464 PDF格式
9687454 2029/08/07 Y U-1464 2017/07/14 PDF格式
001 10285910 2022/10/11 Y PDF格式**本条是由Drugfuture回溯的历史信息**
8017150 2023/02/13 Y PDF格式**本条是由Drugfuture回溯的历史信息**
9855221 2022/02/14 Y PDF格式**本条是由Drugfuture回溯的历史信息**
9931305 2022/02/14 Y PDF格式**本条是由Drugfuture回溯的历史信息**
002 10285910 2022/10/11 Y PDF格式**本条是由Drugfuture回溯的历史信息**
8017150 2023/02/13 Y PDF格式**本条是由Drugfuture回溯的历史信息**
8603514 2024/04/03 Y U-1464 PDF格式**本条是由Drugfuture回溯的历史信息**
9855221 2022/02/14 Y PDF格式**本条是由Drugfuture回溯的历史信息**
9931305 2022/02/14 Y PDF格式**本条是由Drugfuture回溯的历史信息**
003 10285910 2022/10/11 Y PDF格式**本条是由Drugfuture回溯的历史信息**
8017150 2023/02/13 Y PDF格式**本条是由Drugfuture回溯的历史信息**
8603514 2024/04/03 Y U-1464 PDF格式**本条是由Drugfuture回溯的历史信息**
9855221 2022/02/14 Y PDF格式**本条是由Drugfuture回溯的历史信息**
9931305 2022/02/14 Y PDF格式**本条是由Drugfuture回溯的历史信息**
004 10285910 2022/10/11 Y PDF格式**本条是由Drugfuture回溯的历史信息**
8017150 2023/02/13 Y PDF格式**本条是由Drugfuture回溯的历史信息**
9855221 2022/02/14 Y PDF格式**本条是由Drugfuture回溯的历史信息**
9931305 2022/02/14 Y PDF格式**本条是由Drugfuture回溯的历史信息**
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
001 NDF 2013/08/30**本条是由Drugfuture回溯的历史信息**
002 NDF 2013/08/30**本条是由Drugfuture回溯的历史信息**
003 NDF 2013/08/30**本条是由Drugfuture回溯的历史信息**
004 NDF 2013/08/30**本条是由Drugfuture回溯的历史信息**
与本品治疗等效的药品
活性成分:BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 剂型/给药途径:FILM;BUCCAL, SUBLINGUAL 规格:EQ 2MG BASE;EQ 0.5MG BASE 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
022410 001 NDA SUBOXONE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE FILM;BUCCAL, SUBLINGUAL EQ 2MG BASE;EQ 0.5MG BASE Prescription Yes No AB 2010/08/30 INDIVIOR
205299 001 ANDA BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE FILM;BUCCAL, SUBLINGUAL EQ 2MG BASE;EQ 0.5MG BASE Prescription No No AB 2018/06/14 DR REDDYS LABS SA
205954 001 ANDA BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE FILM;BUCCAL, SUBLINGUAL EQ 2MG BASE;EQ 0.5MG BASE Prescription No No AB 2019/01/24 ALVOGEN
211785 001 ANDA BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE FILM;BUCCAL, SUBLINGUAL EQ 2MG BASE;EQ 0.5MG BASE Prescription No No AB 2020/04/17 MYLAN TECHNOLOGIES
活性成分:BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE 剂型/给药途径:FILM;BUCCAL, SUBLINGUAL 规格:EQ 8MG BASE;EQ 2MG BASE 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
022410 002 NDA SUBOXONE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE FILM;BUCCAL, SUBLINGUAL EQ 8MG BASE;EQ 2MG BASE Prescription Yes No AB 2010/08/30 INDIVIOR
205299 002 ANDA BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE FILM;BUCCAL, SUBLINGUAL EQ 8MG BASE;EQ 2MG BASE Prescription No No AB 2018/06/14 DR REDDYS LABS SA
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205954 003 ANDA BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE FILM;BUCCAL, SUBLINGUAL EQ 8MG BASE;EQ 2MG BASE Prescription No No AB 2019/01/24 ALVOGEN
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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
022410 003 NDA SUBOXONE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE FILM;BUCCAL, SUBLINGUAL EQ 4MG BASE;EQ 1MG BASE Prescription Yes No AB 2012/08/10 INDIVIOR
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205954 002 ANDA BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE FILM;BUCCAL, SUBLINGUAL EQ 4MG BASE;EQ 1MG BASE Prescription No No AB 2019/01/24 ALVOGEN
211785 002 ANDA BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE FILM;BUCCAL, SUBLINGUAL EQ 4MG BASE;EQ 1MG BASE Prescription No No AB 2020/04/17 MYLAN TECHNOLOGIES
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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
022410 004 NDA SUBOXONE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE FILM;BUCCAL, SUBLINGUAL EQ 12MG BASE;EQ 3MG BASE Prescription Yes Yes AB 2012/08/10 INDIVIOR
205806 002 ANDA BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE FILM;BUCCAL, SUBLINGUAL EQ 12MG BASE;EQ 3MG BASE Prescription No No AB 2018/06/14 DR REDDYS LABS SA
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205954 004 ANDA BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE FILM;BUCCAL, SUBLINGUAL EQ 12MG BASE;EQ 3MG BASE Prescription No No AB 2019/01/24 ALVOGEN
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