药品注册申请号：203326
申请类型：ANDA (仿制药申请)
申请人：HIKMA
申请人全名：HIKMA PHARMACEUTICALS USA 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 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 2MG BASE;EQ 0.5MG BASE No No AB 2014/06/27 2014/06/27 Prescription
002 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 8MG BASE;EQ 2MG BASE No Yes AB 2014/06/27 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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2014/06/27 ORIG-1（原始申请） Approval
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2025/02/21 SUPPL-36（补充） Approval REMS - MODIFIED - D-N-A
2024/03/20 SUPPL-29（补充） Approval REMS - MODIFIED - D-N-A
2023/12/15 SUPPL-33（补充） Approval Labeling-Package Insert STANDARD
2023/06/06 SUPPL-30（补充） Approval Labeling-Package Insert STANDARD
2022/12/16 SUPPL-27（补充） Approval REMS - MODIFIED - D-N-A
2022/06/17 SUPPL-25（补充） Approval Labeling-Package Insert STANDARD
2022/06/17 SUPPL-23（补充） Approval Labeling-Package Insert STANDARD
2022/06/14 SUPPL-21（补充） Approval Labeling-Package Insert STANDARD
2022/05/03 SUPPL-24（补充） Approval REMS - MODIFIED - D-N-A
2021/03/04 SUPPL-16（补充） Approval Labeling-Package Insert STANDARD
2019/10/07 SUPPL-14（补充） Approval Labeling-Package Insert STANDARD
2018/10/31 SUPPL-11（补充） Approval REMS - MODIFIED - D-N-A
2018/02/01 SUPPL-10（补充） Approval Labeling-Package Insert STANDARD
2017/05/23 SUPPL-7（补充） Approval REMS-Modified
2016/12/16 SUPPL-6（补充） Approval Labeling-Package Insert STANDARD
2016/12/16 SUPPL-5（补充） Approval Labeling-Package Insert STANDARD
2016/07/07 SUPPL-4（补充） Approval REMS-Modified
2015/02/12 SUPPL-2（补充） Approval REMS-Proposal
2015/02/04 SUPPL-3（补充） Approval Labeling-Package Insert 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
无
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
无
与本品治疗等效的药品
>>>活性成分:BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE; 剂型/给药途径:TABLET;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
203136 001 ANDA BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 2MG BASE;EQ 0.5MG BASE Prescription No No AB 2013/02/22 AMNEAL PHARMS
091422 001 ANDA BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 2MG BASE;EQ 0.5MG BASE Prescription No No AB 2013/02/22 ACTAVIS ELIZABETH
203326 001 ANDA BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 2MG BASE;EQ 0.5MG BASE Prescription No No AB 2014/06/27 HIKMA
204431 001 ANDA BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 2MG BASE;EQ 0.5MG BASE Prescription No No AB 2015/10/16 ETHYPHARM
201633 001 ANDA BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 2MG BASE;EQ 0.5MG BASE Prescription No No AB 2016/08/05 SUN PHARM
205022 001 ANDA BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 2MG BASE;EQ 0.5MG BASE Prescription No No AB 2016/09/19 LANNETT CO INC
207000 001 ANDA BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 2MG BASE;EQ 0.5MG BASE Prescription No No AB 2017/12/13 SPECGX LLC
205601 001 ANDA BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 2MG BASE;EQ 0.5MG BASE Prescription No No AB 2020/03/30 RHODES PHARMS
209069 001 ANDA BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 2MG BASE;EQ 0.5MG BASE Prescription No No AB 2020/07/17 WES PHARMA INC
214930 001 ANDA BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 2MG BASE;EQ 0.5MG BASE Prescription No No AB 2021/06/15 ALKEM LABS LTD
>>>活性成分:BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE; 剂型/给药途径:TABLET;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
203136 002 ANDA BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 8MG BASE;EQ 2MG BASE Prescription No No AB 2013/02/22 AMNEAL PHARMS
091422 002 ANDA BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 8MG BASE;EQ 2MG BASE Prescription No No AB 2013/02/22 ACTAVIS ELIZABETH
203326 002 ANDA BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 8MG BASE;EQ 2MG BASE Prescription No Yes AB 2014/06/27 HIKMA
204431 002 ANDA BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 8MG BASE;EQ 2MG BASE Prescription No No AB 2015/10/16 ETHYPHARM
201633 002 ANDA BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 8MG BASE;EQ 2MG BASE Prescription No No AB 2016/08/05 SUN PHARM
205022 002 ANDA BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 8MG BASE;EQ 2MG BASE Prescription No No AB 2016/09/19 LANNETT CO INC
207000 002 ANDA BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 8MG BASE;EQ 2MG BASE Prescription No No AB 2017/12/13 SPECGX LLC
205601 002 ANDA BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 8MG BASE;EQ 2MG BASE Prescription No No AB 2020/03/30 RHODES PHARMS
209069 002 ANDA BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 8MG BASE;EQ 2MG BASE Prescription No No AB 2020/07/17 WES PHARMA INC
214930 002 ANDA BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TABLET;SUBLINGUAL EQ 8MG BASE;EQ 2MG BASE Prescription No No AB 2021/06/15 ALKEM LABS LTD
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