药品注册申请号：016798
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 SINEQUAN DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1969/09/23 Approved Prior to Jan 1, 1982 Discontinued
002 SINEQUAN DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
003 SINEQUAN DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
005 SINEQUAN DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
006 SINEQUAN DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
007 SINEQUAN DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
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
2014/07/14 SUPPL-56（补充） Approval Labeling 901 REQUIRED
2007/08/02 SUPPL-54（补充） Approval Labeling STANDARD
2005/02/18 SUPPL-53（补充） Approval Labeling STANDARD
2003/09/30 SUPPL-50（补充） Approval Labeling STANDARD
2000/04/10 SUPPL-48（补充） Approval Labeling STANDARD
2000/03/27 SUPPL-47（补充） Approval Manufacturing (CMC) STANDARD
1994/07/21 SUPPL-44（补充） Approval Manufacturing (CMC) STANDARD
1990/04/04 SUPPL-43（补充） Approval Manufacturing (CMC) STANDARD
1988/10/27 SUPPL-40（补充） Approval Manufacturing (CMC) STANDARD
1988/10/27 SUPPL-39（补充） Approval Manufacturing (CMC) STANDARD
1987/09/01 SUPPL-38（补充） Approval Manufacturing (CMC) STANDARD
1985/10/28 SUPPL-35（补充） Approval Manufacturing (CMC) STANDARD
1984/12/11 SUPPL-33（补充） Approval Manufacturing (CMC) STANDARD
1984/09/13 SUPPL-34（补充） Approval Labeling
1984/05/10 SUPPL-32（补充） Approval Manufacturing (CMC) STANDARD
1984/05/01 SUPPL-31（补充） Approval Labeling
1983/09/26 SUPPL-30（补充） Approval Manufacturing (CMC) STANDARD
1983/09/26 SUPPL-29（补充） Approval Manufacturing (CMC) STANDARD
1983/07/22 SUPPL-28（补充） Approval Manufacturing (CMC) STANDARD
1981/02/12 SUPPL-27（补充） Approval Manufacturing (CMC) STANDARD
1980/08/12 SUPPL-26（补充） Approval Manufacturing (CMC) STANDARD
1979/10/17 SUPPL-25（补充） Approval Labeling
1978/07/12 SUPPL-23（补充） Approval Manufacturing (CMC) STANDARD
1978/07/07 SUPPL-24（补充） Approval Manufacturing (CMC) STANDARD
1978/06/06 SUPPL-22（补充） Approval Manufacturing (CMC) STANDARD
1978/03/15 SUPPL-20（补充） Approval Labeling
1978/03/15 SUPPL-19（补充） Approval Manufacturing (CMC) STANDARD
1977/10/12 SUPPL-21（补充） Approval Manufacturing (CMC) STANDARD
1976/10/28 SUPPL-18（补充） Approval Manufacturing (CMC) STANDARD
1976/06/04 SUPPL-16（补充） Approval Manufacturing (CMC) STANDARD
1976/03/11 SUPPL-17（补充） Approval Manufacturing (CMC) STANDARD
1975/06/13 SUPPL-11（补充） Approval Labeling
1975/04/07 SUPPL-14（补充） Approval Manufacturing (CMC) STANDARD
1975/03/31 SUPPL-12（补充） Approval Manufacturing (CMC) STANDARD
1969/09/23 ORIG-1（原始申请） Approval Type 1 - New Molecular Entity 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
本品无治疗等效药品
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
©2006-2024 DrugFuture->U.S. FDA Drugs Database