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 |
2021/05/17 |
SUPPL-70(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2021/05/17 |
SUPPL-69(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2018/01/02 |
SUPPL-68(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2018/01/02 |
SUPPL-67(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2018/01/02 |
SUPPL-62(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2012/12/14 |
SUPPL-60(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2010/07/28 |
SUPPL-52(补充) |
Approval |
Labeling |
|
|
|
2005/09/01 |
SUPPL-32(补充) |
Approval |
Labeling |
|
|
|
2003/04/18 |
SUPPL-27(补充) |
Approval |
Labeling |
|
|
|
2002/12/23 |
SUPPL-28(补充) |
Approval |
Labeling |
|
|
|
2001/05/01 |
SUPPL-25(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2001/04/25 |
SUPPL-26(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2000/12/26 |
SUPPL-24(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2000/08/09 |
SUPPL-23(补充) |
Approval |
Labeling |
|
|
|
1993/09/01 |
SUPPL-21(补充) |
Approval |
Labeling |
|
|
|
1993/04/14 |
SUPPL-20(补充) |
Approval |
Labeling |
|
|
|
1992/10/23 |
SUPPL-19(补充) |
Approval |
Labeling |
|
|
|
1992/02/26 |
SUPPL-18(补充) |
Approval |
Labeling |
|
|
|
1991/05/31 |
SUPPL-16(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1990/11/15 |
SUPPL-17(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1990/06/29 |
SUPPL-15(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/10/14 |
SUPPL-13(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/09/01 |
SUPPL-12(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1983/02/02 |
ORIG-1(原始申请) |
Approval |
|
|
|
|
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 |
与本品治疗等效的药品
活性成分:DOXYCYCLINE HYCLATE 剂型/给药途径:TABLET;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 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
062269 |
002 |
ANDA |
DOXYCYCLINE HYCLATE |
DOXYCYCLINE HYCLATE |
TABLET;ORAL |
EQ 100MG BASE |
Prescription |
No |
Yes |
AB |
1982/11/08
|
CARIBE HOLDINGS |
062421 |
001 |
ANDA |
DOXYCYCLINE HYCLATE |
DOXYCYCLINE HYCLATE |
TABLET;ORAL |
EQ 100MG BASE |
Prescription |
No |
No |
AB |
1983/02/02
|
ACTAVIS LABS FL INC |
062432 |
001 |
ANDA |
DOXYCYCLINE HYCLATE |
DOXYCYCLINE HYCLATE |
TABLET;ORAL |
EQ 100MG BASE |
Prescription |
No |
No |
AB |
1983/02/15
|
MYLAN |
062505 |
001 |
ANDA |
DOXYCYCLINE HYCLATE |
DOXYCYCLINE HYCLATE |
TABLET;ORAL |
EQ 100MG BASE |
Prescription |
No |
No |
AB |
1984/09/11
|
CHARTWELL |
062677 |
001 |
ANDA |
DOXYCYCLINE HYCLATE |
DOXYCYCLINE HYCLATE |
TABLET;ORAL |
EQ 100MG BASE |
Prescription |
No |
No |
AB |
1986/07/10
|
SUN PHARM INDUSTRIES |
065095 |
001 |
ANDA |
DOXYCYCLINE HYCLATE |
DOXYCYCLINE HYCLATE |
TABLET;ORAL |
EQ 100MG BASE |
Prescription |
No |
No |
AB |
2003/07/02
|
HIKMA INTL PHARMS |
207558 |
001 |
ANDA |
DOXYCYCLINE HYCLATE |
DOXYCYCLINE HYCLATE |
TABLET;ORAL |
EQ 100MG BASE |
Prescription |
No |
No |
AB |
2017/09/06
|
NOVEL LABS INC |
207773 |
001 |
ANDA |
DOXYCYCLINE HYCLATE |
DOXYCYCLINE HYCLATE |
TABLET;ORAL |
EQ 100MG BASE |
Prescription |
No |
No |
AB |
2017/10/30
|
ZYDUS LIFESCIENCES |
211343 |
001 |
ANDA |
DOXYCYCLINE HYCLATE |
DOXYCYCLINE HYCLATE |
TABLET;ORAL |
EQ 100MG BASE |
Prescription |
No |
No |
AB |
2019/10/09
|
CHANGZHOU PHARM |
210664 |
001 |
ANDA |
DOXYCYCLINE HYCLATE |
DOXYCYCLINE HYCLATE |
TABLET;ORAL |
EQ 100MG BASE |
Prescription |
No |
No |
AB |
2020/03/16
|
ACELLA |
212487 |
001 |
ANDA |
DOXYCYCLINE HYCLATE |
DOXYCYCLINE HYCLATE |
TABLET;ORAL |
EQ 100MG BASE |
Discontinued |
No |
No |
AB |
2022/03/30
|
PRAXGEN |
216599 |
001 |
ANDA |
DOXYCYCLINE HYCLATE |
DOXYCYCLINE HYCLATE |
TABLET;ORAL |
EQ 100MG BASE |
Discontinued |
No |
No |
AB |
2022/10/24
|
AMNEAL |
209560 |
001 |
ANDA |
DOXYCYCLINE HYCLATE |
DOXYCYCLINE HYCLATE |
TABLET;ORAL |
EQ 100MG BASE |
Discontinued |
No |
No |
AB |
2024/04/15
|
NOSTRUM LABS INC |