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 |
2016/11/16 |
SUPPL-21(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2002/02/15 |
SUPPL-15(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2001/12/04 |
SUPPL-13(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2001/07/19 |
SUPPL-10(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2001/07/18 |
SUPPL-12(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2001/04/12 |
SUPPL-11(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2000/10/02 |
SUPPL-9(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1999/11/09 |
SUPPL-8(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1999/03/15 |
SUPPL-7(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1998/05/19 |
SUPPL-5(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1998/02/04 |
SUPPL-6(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1997/04/18 |
SUPPL-4(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1996/05/22 |
SUPPL-3(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
1995/08/03 |
SUPPL-1(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1995/06/12 |
SUPPL-2(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1993/07/30 |
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 |
无 |
与本品治疗等效的药品
活性成分:OFLOXACIN 剂型/给药途径:SOLUTION/DROPS;OPHTHALMIC 规格:0.3% 治疗等效代码:AT
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 |
217904 |
001 |
ANDA |
OFLOXACIN |
OFLOXACIN |
SOLUTION/DROPS;OPHTHALMIC |
0.3% |
Prescription |
No |
No |
AT |
--
|
CAPLIN |
019921 |
001 |
NDA |
OCUFLOX |
OFLOXACIN |
SOLUTION/DROPS;OPHTHALMIC |
0.3% |
Prescription |
Yes |
Yes |
AT |
1993/07/30
|
ALLERGAN |
076513 |
001 |
ANDA |
OFLOXACIN |
OFLOXACIN |
SOLUTION/DROPS;OPHTHALMIC |
0.3% |
Prescription |
No |
No |
AT |
2004/05/14
|
APOTEX INC |
076615 |
001 |
ANDA |
OFLOXACIN |
OFLOXACIN |
SOLUTION/DROPS;OPHTHALMIC |
0.3% |
Discontinued |
No |
No |
AT |
2004/05/14
|
EPIC PHARMA LLC |
076622 |
001 |
ANDA |
OFLOXACIN |
OFLOXACIN |
SOLUTION/DROPS;OPHTHALMIC |
0.3% |
Prescription |
No |
No |
AT |
2004/05/14
|
BAUSCH AND LOMB |
076407 |
001 |
ANDA |
OFLOXACIN |
OFLOXACIN |
SOLUTION/DROPS;OPHTHALMIC |
0.3% |
Prescription |
No |
No |
AT |
2008/04/15
|
SENTISS |
078559 |
001 |
ANDA |
OFLOXACIN |
OFLOXACIN |
SOLUTION/DROPS;OPHTHALMIC |
0.3% |
Prescription |
No |
No |
AT |
2009/02/25
|
FDC LTD |
202692 |
001 |
ANDA |
OFLOXACIN |
OFLOXACIN |
SOLUTION/DROPS;OPHTHALMIC |
0.3% |
Prescription |
No |
No |
AT |
2013/04/29
|
ALTAIRE PHARMS INC |
215886 |
001 |
ANDA |
OFLOXACIN |
OFLOXACIN |
SOLUTION/DROPS;OPHTHALMIC |
0.3% |
Prescription |
No |
No |
AT |
2022/11/23
|
MANKIND PHARMA |
211524 |
001 |
ANDA |
OFLOXACIN |
OFLOXACIN |
SOLUTION/DROPS;OPHTHALMIC |
0.3% |
Prescription |
No |
No |
AT |
2024/03/01
|
AMNEAL |