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 |
2017/05/22 |
SUPPL-37(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/08/24 |
SUPPL-36(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/04/22 |
SUPPL-34(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/03/10 |
SUPPL-33(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/03/02 |
SUPPL-35(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2015/03/23 |
SUPPL-32(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2013/04/29 |
SUPPL-31(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2010/12/28 |
SUPPL-26(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2009/05/21 |
SUPPL-24(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2007/10/16 |
SUPPL-21(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2004/08/25 |
SUPPL-15(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2004/07/30 |
SUPPL-16(补充) |
Approval |
Efficacy |
UNKNOWN
|
|
|
2004/01/16 |
SUPPL-13(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2003/09/26 |
SUPPL-11(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2002/10/03 |
SUPPL-8(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2002/05/31 |
SUPPL-7(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2001/10/26 |
SUPPL-4(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2001/06/25 |
SUPPL-3(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2001/06/18 |
SUPPL-5(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2001/05/18 |
SUPPL-6(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2000/09/25 |
SUPPL-1(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1999/10/01 |
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)
与本品治疗等效的药品
活性成分:BUDESONIDE 剂型/给药途径:SPRAY, METERED;NASAL 规格:0.032MG/INH 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 |
020746 |
001 |
NDA |
RHINOCORT |
BUDESONIDE |
SPRAY, METERED;NASAL |
0.032MG/INH |
Prescription |
Yes |
No |
AB |
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|
J AND J CONSUMER INC |