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 |
2023/12/18 |
SUPPL-22(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2023/12/18 |
SUPPL-17(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2023/12/04 |
SUPPL-29(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2017/12/22 |
SUPPL-18(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/03/15 |
SUPPL-13(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/03/13 |
SUPPL-14(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/01/29 |
SUPPL-12(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2008/04/04 |
SUPPL-10(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2004/04/30 |
SUPPL-5(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2004/04/30 |
SUPPL-4(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2004/04/30 |
SUPPL-3(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2000/12/13 |
SUPPL-2(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2000/08/11 |
ORIG-1(原始申请) |
Approval |
Type 1 - New Molecular Entity |
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:CETRORELIX ACETATE 剂型/给药途径:POWDER;SUBCUTANEOUS 规格:EQ 0.25MG BASE/VIAL 治疗等效代码:AP
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 |
021197 |
001 |
NDA |
CETROTIDE |
CETRORELIX ACETATE |
POWDER;SUBCUTANEOUS |
EQ 0.25MG BASE/VIAL |
Prescription |
Yes |
Yes |
AP |
2000/08/11
|
EMD SERONO INC |
215737 |
001 |
ANDA |
CETRORELIX ACETATE |
CETRORELIX ACETATE |
POWDER;SUBCUTANEOUS |
EQ 0.25MG BASE/VIAL |
Prescription |
No |
No |
AP |
2022/08/12
|
TEVA PHARMS INC |
217776 |
001 |
ANDA |
CETRORELIX ACETATE |
CETRORELIX ACETATE |
POWDER;SUBCUTANEOUS |
EQ 0.25MG BASE/VIAL |
Prescription |
No |
No |
AP |
2024/04/16
|
QILU |
214540 |
001 |
ANDA |
CETRORELIX ACETATE |
CETRORELIX ACETATE |
POWDER;SUBCUTANEOUS |
EQ 0.25MG BASE/VIAL |
Prescription |
No |
No |
AP |
2024/04/24
|
LIVZON GRP |
218150 |
001 |
ANDA |
CETRORELIX ACETATE |
CETRORELIX ACETATE |
POWDER;SUBCUTANEOUS |
EQ 0.25MG BASE/VIAL |
Prescription |
No |
No |
AP |
2024/04/25
|
GLAND |