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DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1969/09/23 Approved Prior to Jan 1, 1982 Discontinued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DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued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DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued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DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued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DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued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DOXEPIN HYDROCHLORIDE CAPSULE;ORAL EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued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
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与本品治疗等效的药品
本品无治疗等效药品
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