药品注册申请号：017442
申请类型：NDA (新药申请)
申请人：PFIZER
申请人全名：PFIZER LABORATORIES DIV PFIZER 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 MINIPRESS PRAZOSIN HYDROCHLORIDE CAPSULE;ORAL EQ 5MG BASE Yes No AB 1976/06/23 Approved Prior to Jan 1, 1982 Prescription
002 MINIPRESS PRAZOSIN HYDROCHLORIDE CAPSULE;ORAL EQ 1MG BASE Yes No AB Approved Prior to Jan 1, 1982 Prescription
003 MINIPRESS PRAZOSIN HYDROCHLORIDE CAPSULE;ORAL EQ 2MG BASE Yes Yes AB Approved Prior to Jan 1, 1982 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
2016/01/08 SUPPL-44（补充） Approval Manufacturing (CMC) PRIORITY
2015/02/27 SUPPL-43（补充） Approval Labeling STANDARD
2014/07/28 SUPPL-42（补充） Approval Manufacturing (CMC) PRIORITY
2013/11/04 SUPPL-41（补充） Approval Labeling STANDARD
2009/07/10 SUPPL-35（补充） Approval Labeling STANDARD
2009/04/06 SUPPL-33（补充） Approval Labeling STANDARD
2001/06/12 SUPPL-29（补充） Approval Labeling STANDARD
1994/05/10 SUPPL-28（补充） Approval Manufacturing (CMC) PRIORITY
1989/08/21 SUPPL-26（补充） Approval Manufacturing (CMC) PRIORITY
1989/05/01 SUPPL-27（补充） Approval Labeling
1988/10/14 SUPPL-25（补充） Approval Manufacturing (CMC) PRIORITY
1988/08/29 SUPPL-24（补充） Approval Manufacturing (CMC) PRIORITY
1988/06/06 SUPPL-22（补充） Approval Manufacturing (CMC) PRIORITY
1987/07/14 SUPPL-23（补充） Approval Manufacturing (CMC) PRIORITY
1986/04/25 SUPPL-20（补充） Approval Labeling
1986/04/25 SUPPL-13（补充） Approval Labeling
1985/09/27 SUPPL-21（补充） Approval Manufacturing (CMC) PRIORITY
1985/02/26 SUPPL-19（补充） Approval Labeling
1984/09/13 SUPPL-17（补充） Approval Manufacturing (CMC) PRIORITY
1984/08/13 SUPPL-18（补充） Approval Labeling
1984/08/03 SUPPL-16（补充） Approval Manufacturing (CMC) PRIORITY
1984/08/01 SUPPL-15（补充） Approval Manufacturing (CMC) PRIORITY
1983/11/29 SUPPL-14（补充） Approval Manufacturing (CMC) PRIORITY
1982/08/06 SUPPL-4（补充） Approval Manufacturing (CMC) PRIORITY
1982/02/19 SUPPL-12（补充） Approval Labeling
1982/02/19 SUPPL-11（补充） Approval Manufacturing (CMC) PRIORITY
1981/11/17 SUPPL-10（补充） Approval Manufacturing (CMC) PRIORITY
1981/09/25 SUPPL-9（补充） Approval Manufacturing (CMC) PRIORITY
1981/07/30 SUPPL-8（补充） Approval Manufacturing (CMC) PRIORITY
1981/01/14 SUPPL-7（补充） Approval Labeling
1979/01/10 SUPPL-5（补充） Approval Labeling
1978/11/27 SUPPL-3（补充） Approval Manufacturing (CMC) PRIORITY
1977/07/13 SUPPL-1（补充） Approval Manufacturing (CMC) PRIORITY
1977/06/14 SUPPL-2（补充） Approval Labeling
1976/06/23 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
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:PRAZOSIN HYDROCHLORIDE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 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
017442 001 NDA MINIPRESS PRAZOSIN HYDROCHLORIDE CAPSULE;ORAL EQ 5MG BASE Prescription Yes No AB Approved Prior to Jan 1, 1982 PFIZER
071745 001 ANDA PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE CAPSULE;ORAL EQ 5MG BASE Prescription No No AB 1988/09/12 TEVA PHARMS
072575 001 ANDA PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE CAPSULE;ORAL EQ 5MG BASE Prescription No No AB 1989/05/16 MYLAN
210971 003 ANDA PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE CAPSULE;ORAL EQ 5MG BASE Prescription No No AB 2018/10/03 NOVITIUM PHARMA
214608 003 ANDA PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE CAPSULE;ORAL EQ 5MG BASE Prescription No No AB 2021/12/23 GRANULES
213406 003 ANDA PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE CAPSULE;ORAL EQ 5MG BASE Prescription No No AB 2022/10/21 APPCO
215697 003 ANDA PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE CAPSULE;ORAL EQ 5MG BASE Prescription No No AB 2022/12/30 MANKIND PHARMA
217268 003 ANDA PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE CAPSULE;ORAL EQ 5MG BASE Prescription No No AB 2023/03/06 ALEMBIC
213052 003 ANDA PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE CAPSULE;ORAL EQ 5MG BASE Prescription No No AB 2023/03/31 AUROBINDO PHARMA LTD
214083 003 ANDA PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE CAPSULE;ORAL EQ 5MG BASE Discontinued No No AB 2024/01/03 LANNETT CO INC
216727 003 ANDA PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE CAPSULE;ORAL EQ 5MG BASE Prescription No No AB 2024/09/17 MSN
活性成分:PRAZOSIN HYDROCHLORIDE 剂型/给药途径:CAPSULE;ORAL 规格: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
071994 001 ANDA PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE CAPSULE;ORAL EQ 1MG BASE Prescription No No AB -- IVAX SUB TEVA PHARMS
017442 002 NDA MINIPRESS PRAZOSIN HYDROCHLORIDE CAPSULE;ORAL EQ 1MG BASE Prescription Yes No AB Approved Prior to Jan 1, 1982 PFIZER
071745 002 ANDA PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE CAPSULE;ORAL EQ 1MG BASE Prescription No No AB 1988/09/12 TEVA PHARMS
072575 003 ANDA PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE CAPSULE;ORAL EQ 1MG BASE Prescription No No AB 1989/05/16 MYLAN
072577 002 ANDA PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE CAPSULE;ORAL EQ 1MG BASE Discontinued No No AB 1989/05/16 ANI PHARMS
210971 001 ANDA PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE CAPSULE;ORAL EQ 1MG BASE Prescription No No AB 2018/10/03 NOVITIUM PHARMA
214608 001 ANDA PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE CAPSULE;ORAL EQ 1MG BASE Prescription No No AB 2021/12/23 GRANULES
213406 001 ANDA PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE CAPSULE;ORAL EQ 1MG BASE Prescription No No AB 2022/10/21 APPCO
215697 001 ANDA PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE CAPSULE;ORAL EQ 1MG BASE Prescription No No AB 2022/12/30 MANKIND PHARMA
217268 001 ANDA PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE CAPSULE;ORAL EQ 1MG BASE Prescription No No AB 2023/03/06 ALEMBIC
213052 001 ANDA PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE CAPSULE;ORAL EQ 1MG BASE Prescription No No AB 2023/03/31 AUROBINDO PHARMA LTD
214083 001 ANDA PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE CAPSULE;ORAL EQ 1MG BASE Discontinued No No AB 2024/01/03 LANNETT CO INC
216727 001 ANDA PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE CAPSULE;ORAL EQ 1MG BASE Prescription No No AB 2024/09/17 MSN
活性成分:PRAZOSIN HYDROCHLORIDE 剂型/给药途径:CAPSULE;ORAL 规格: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
071995 001 ANDA PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE CAPSULE;ORAL EQ 2MG BASE Prescription No No AB -- TEVA PHARMS
017442 003 NDA MINIPRESS PRAZOSIN HYDROCHLORIDE CAPSULE;ORAL EQ 2MG BASE Prescription Yes Yes AB Approved Prior to Jan 1, 1982 PFIZER
071745 003 ANDA PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE CAPSULE;ORAL EQ 2MG BASE Prescription No No AB 1988/09/12 TEVA PHARMS
072575 002 ANDA PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE CAPSULE;ORAL EQ 2MG BASE Prescription No No AB 1989/05/16 MYLAN
072577 001 ANDA PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE CAPSULE;ORAL EQ 2MG BASE Discontinued No No AB 1989/05/16 ANI PHARMS
210971 002 ANDA PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE CAPSULE;ORAL EQ 2MG BASE Prescription No No AB 2018/10/03 NOVITIUM PHARMA
214608 002 ANDA PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE CAPSULE;ORAL EQ 2MG BASE Prescription No No AB 2021/12/23 GRANULES
213406 002 ANDA PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE CAPSULE;ORAL EQ 2MG BASE Prescription No No AB 2022/10/21 APPCO
215697 002 ANDA PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE CAPSULE;ORAL EQ 2MG BASE Prescription No No AB 2022/12/30 MANKIND PHARMA
217268 002 ANDA PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE CAPSULE;ORAL EQ 2MG BASE Prescription No No AB 2023/03/06 ALEMBIC
213052 002 ANDA PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE CAPSULE;ORAL EQ 2MG BASE Prescription No No AB 2023/03/31 AUROBINDO PHARMA LTD
214083 002 ANDA PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE CAPSULE;ORAL EQ 2MG BASE Discontinued No No AB 2024/01/03 LANNETT CO INC
216727 002 ANDA PRAZOSIN HYDROCHLORIDE PRAZOSIN HYDROCHLORIDE CAPSULE;ORAL EQ 2MG BASE Prescription No No AB 2024/09/17 MSN
更多信息
药品NDC数据与药品包装、标签说明书
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