药品注册申请号：212756
申请类型：ANDA (仿制药申请)
申请人：DIFGEN PHARMS
申请人全名：DIFGEN PHARMACEUTICALS 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 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE FILM;BUCCAL, SUBLINGUAL EQ 8MG BASE;EQ 2MG BASE No No AB 2022/06/02 2022/06/02 Prescription
002 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE FILM;BUCCAL, SUBLINGUAL EQ 12MG BASE;EQ 3MG BASE No No AB 2022/06/02 Prescription
003 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE FILM;BUCCAL, SUBLINGUAL EQ 2MG BASE;EQ 0.5MG BASE No No AB 2025/02/13 Prescription
004 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE FILM;BUCCAL, SUBLINGUAL EQ 4MG BASE;EQ 1MG BASE No No AB 2025/02/13 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
2022/06/02 ORIG-1（原始申请） Approval STANDARD
>>>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-13（补充） Approval REMS - MODIFIED - D-N-A
2024/10/10 SUPPL-7（补充） Approval Labeling-Package Insert STANDARD
2024/10/10 SUPPL-5（补充） Approval Labeling-Package Insert,Labeling-Patient Package Insert STANDARD
2024/10/10 SUPPL-1（补充） Approval Labeling-Package Insert,Labeling-Patient Package Insert STANDARD
2024/03/20 SUPPL-4（补充） Approval REMS - MODIFIED - D-N-A
2022/12/16 SUPPL-2（补充） Approval REMS - MODIFIED - D-N-A
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: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
207607 001 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 MYLAN TECHNOLOGIES
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
212756 001 ANDA BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE FILM;BUCCAL, SUBLINGUAL EQ 8MG BASE;EQ 2MG BASE Prescription No No AB 2022/06/02 DIFGEN PHARMS
>>>活性成分:BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE; 剂型/给药途径:FILM;BUCCAL, SUBLINGUAL; 规格:EQ 12MG BASE;EQ 3MG 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 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
207607 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 MYLAN TECHNOLOGIES
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
212756 002 ANDA BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE FILM;BUCCAL, SUBLINGUAL EQ 12MG BASE;EQ 3MG BASE Prescription No No AB 2022/06/02 DIFGEN PHARMS
>>>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
212756 003 ANDA BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE FILM;BUCCAL, SUBLINGUAL EQ 2MG BASE;EQ 0.5MG BASE Prescription No No AB 2025/02/13 DIFGEN PHARMS
>>>活性成分:BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE; 剂型/给药途径:FILM;BUCCAL, SUBLINGUAL; 规格:EQ 4MG BASE;EQ 1MG 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 003 NDA SUBOXONE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE FILM;BUCCAL, SUBLINGUAL EQ 4MG BASE;EQ 1MG BASE Prescription Yes No AB 2012/08/10 INDIVIOR
205806 001 ANDA BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE FILM;BUCCAL, SUBLINGUAL EQ 4MG BASE;EQ 1MG BASE Prescription No No AB 2018/06/14 DR REDDYS LABS SA
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
212756 004 ANDA BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE FILM;BUCCAL, SUBLINGUAL EQ 4MG BASE;EQ 1MG BASE Prescription No No AB 2025/02/13 DIFGEN PHARMS
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药品NDC数据与药品包装、标签说明书
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