药品注册申请号:050641
申请类型:NDA (新药申请)
申请人:CHARTWELL RX
申请人全名:CHARTWELL RX SCIENCES 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 MONODOX DOXYCYCLINE CAPSULE;ORAL EQ 100MG BASE Yes No AB 1989/12/29 1989/12/29 Prescription
002 MONODOX DOXYCYCLINE CAPSULE;ORAL EQ 50MG BASE Yes No AB 1992/02/10 Prescription
003 MONODOX DOXYCYCLINE CAPSULE;ORAL EQ 75MG BASE Yes No AB 2006/10/18 Prescription
004 MONODOX DOXYCYCLINE CAPSULE;ORAL EQ 150MG BASE Yes No AB 2022/02/17 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
2024/05/08 SUPPL-33(补充) Approval Labeling STANDARD
2022/02/17 SUPPL-32(补充) Approval Manufacturing (CMC) N/A
2017/04/03 SUPPL-29(补充) Approval Labeling STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
2016/08/05 SUPPL-28(补充) Approval Manufacturing (CMC) STANDARD
2013/10/11 SUPPL-27(补充) Approval Labeling STANDARD
2012/01/11 SUPPL-18(补充) Approval Labeling STANDARD
2011/03/08 SUPPL-26(补充) Approval Labeling STANDARD
2007/12/20 SUPPL-14(补充) Approval Labeling STANDARD
2007/01/31 SUPPL-13(补充) Approval Manufacturing (CMC) N/A
2002/06/18 SUPPL-10(补充) Approval Labeling STANDARD
2002/03/21 SUPPL-8(补充) Approval Labeling STANDARD
1994/01/07 SUPPL-7(补充) Approval Manufacturing (CMC) STANDARD
1992/06/24 SUPPL-6(补充) Approval Manufacturing (CMC) STANDARD
1992/03/06 SUPPL-5(补充) Approval Labeling
1992/02/10 SUPPL-3(补充) Approval Manufacturing (CMC) STANDARD
1991/11/15 SUPPL-4(补充) Approval Labeling
1991/11/15 SUPPL-1(补充) Approval Labeling
1991/09/25 SUPPL-2(补充) Approval Manufacturing (CMC) STANDARD
1989/12/29 ORIG-1(原始申请) Approval Type 3 - New Dosage Form 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
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
与本品治疗等效的药品
活性成分:DOXYCYCLINE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 100MG 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
050641 001 NDA MONODOX DOXYCYCLINE CAPSULE;ORAL EQ 100MG BASE Prescription Yes No AB 1989/12/29 CHARTWELL RX
065053 002 ANDA DOXYCYCLINE DOXYCYCLINE CAPSULE;ORAL EQ 100MG BASE Prescription No Yes AB 2000/11/22 SUN PHARM INDS LTD
065055 002 ANDA DOXYCYCLINE DOXYCYCLINE CAPSULE;ORAL EQ 100MG BASE Prescription No No AB 2000/12/01 STRIDES PHARMA
204234 003 ANDA DOXYCYCLINE DOXYCYCLINE CAPSULE;ORAL EQ 100MG BASE Prescription No No AB 2014/03/05 LUPIN LTD
204446 003 ANDA DOXYCYCLINE DOXYCYCLINE CAPSULE;ORAL EQ 100MG BASE Discontinued No No AB 2015/05/28 COSETTE
205115 003 ANDA DOXYCYCLINE DOXYCYCLINE CAPSULE;ORAL EQ 100MG BASE Prescription No No AB 2016/02/18 ZYDUS PHARMS
209165 002 ANDA DOXYCYCLINE DOXYCYCLINE CAPSULE;ORAL EQ 100MG BASE Prescription No No AB 2017/07/28 ALEMBIC
209396 003 ANDA DOXYCYCLINE DOXYCYCLINE CAPSULE;ORAL EQ 100MG BASE Prescription No No AB 2017/09/29 DR REDDYS LABS SA
活性成分:DOXYCYCLINE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 50MG 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
050641 002 NDA MONODOX DOXYCYCLINE CAPSULE;ORAL EQ 50MG BASE Prescription Yes No AB 1992/02/10 CHARTWELL RX
065053 001 ANDA DOXYCYCLINE DOXYCYCLINE CAPSULE;ORAL EQ 50MG BASE Prescription No No AB 2000/11/22 SUN PHARM INDS LTD
065055 001 ANDA DOXYCYCLINE DOXYCYCLINE CAPSULE;ORAL EQ 50MG BASE Prescription No No AB 2000/12/01 STRIDES PHARMA
204234 001 ANDA DOXYCYCLINE DOXYCYCLINE CAPSULE;ORAL EQ 50MG BASE Prescription No No AB 2014/03/05 LUPIN LTD
204446 001 ANDA DOXYCYCLINE DOXYCYCLINE CAPSULE;ORAL EQ 50MG BASE Discontinued No No AB 2015/05/28 COSETTE
205115 001 ANDA DOXYCYCLINE DOXYCYCLINE CAPSULE;ORAL EQ 50MG BASE Prescription No No AB 2016/02/18 ZYDUS PHARMS
209396 001 ANDA DOXYCYCLINE DOXYCYCLINE CAPSULE;ORAL EQ 50MG BASE Prescription No No AB 2017/09/29 DR REDDYS LABS SA
活性成分:DOXYCYCLINE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 75MG 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
065053 003 ANDA DOXYCYCLINE DOXYCYCLINE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2003/09/10 SUN PHARM INDS LTD
050641 003 NDA MONODOX DOXYCYCLINE CAPSULE;ORAL EQ 75MG BASE Prescription Yes No AB 2006/10/18 CHARTWELL RX
204234 002 ANDA DOXYCYCLINE DOXYCYCLINE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2014/03/05 LUPIN LTD
204446 002 ANDA DOXYCYCLINE DOXYCYCLINE CAPSULE;ORAL EQ 75MG BASE Discontinued No No AB 2015/05/28 COSETTE
205115 002 ANDA DOXYCYCLINE DOXYCYCLINE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2016/02/18 ZYDUS PHARMS
209165 001 ANDA DOXYCYCLINE DOXYCYCLINE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2017/07/28 ALEMBIC
209396 002 ANDA DOXYCYCLINE DOXYCYCLINE CAPSULE;ORAL EQ 75MG BASE Prescription No No AB 2017/09/29 DR REDDYS LABS SA
活性成分:DOXYCYCLINE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 150MG 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
065055 003 ANDA DOXYCYCLINE DOXYCYCLINE CAPSULE;ORAL EQ 150MG BASE Prescription No Yes AB 2005/07/15 STRIDES PHARMA
050641 004 NDA MONODOX DOXYCYCLINE CAPSULE;ORAL EQ 150MG BASE Prescription Yes No AB 2022/02/17 CHARTWELL RX
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