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 |
2023/11/16 |
SUPPL-116(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2023/01/04 |
SUPPL-115(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2022/04/15 |
SUPPL-114(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2022/01/28 |
SUPPL-113(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2020/07/22 |
SUPPL-110(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2020/05/14 |
SUPPL-109(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2019/12/27 |
SUPPL-107(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2019/07/19 |
SUPPL-106(补充) |
Approval |
Labeling |
STANDARD
;Orphan
|
|
|
2018/09/07 |
SUPPL-104(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2018/01/23 |
SUPPL-102(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/11/18 |
SUPPL-99(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2016/11/15 |
SUPPL-98(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2016/03/14 |
SUPPL-93(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2015/12/03 |
SUPPL-95(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2015/10/02 |
SUPPL-96(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2015/08/03 |
SUPPL-94(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2015/01/26 |
SUPPL-92(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2014/01/28 |
SUPPL-89(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2013/12/06 |
SUPPL-91(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/09/05 |
SUPPL-85(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/09/05 |
SUPPL-83(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/03/08 |
SUPPL-87(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/02/22 |
SUPPL-79(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2009/02/27 |
SUPPL-57(补充) |
Approval |
Efficacy |
UNKNOWN
|
|
|
2002/08/29 |
SUPPL-26(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2002/05/20 |
SUPPL-25(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2002/03/11 |
SUPPL-24(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2002/02/12 |
SUPPL-23(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2001/07/12 |
SUPPL-15(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2001/06/12 |
SUPPL-22(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2001/02/28 |
SUPPL-20(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2001/02/23 |
SUPPL-19(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2001/01/25 |
SUPPL-18(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2000/08/09 |
SUPPL-7(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2000/07/06 |
SUPPL-9(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2000/07/06 |
SUPPL-4(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1999/11/29 |
SUPPL-17(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1999/09/24 |
SUPPL-16(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1999/08/16 |
SUPPL-14(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1999/08/16 |
SUPPL-13(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1999/08/04 |
SUPPL-12(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1999/08/03 |
SUPPL-11(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1999/07/30 |
SUPPL-10(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1999/06/28 |
SUPPL-8(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1999/02/25 |
SUPPL-6(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1999/02/16 |
SUPPL-5(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1998/01/23 |
SUPPL-3(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1998/01/23 |
SUPPL-2(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1997/11/04 |
SUPPL-1(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
;Orphan
|
|
|
1996/12/20 |
ORIG-1(原始申请) |
Approval |
Type 1 - New Molecular Entity |
STANDARD
;Orphan
|
|
|
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:GLATIRAMER ACETATE 剂型/给药途径:INJECTABLE;SUBCUTANEOUS 规格:20MG/ML 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 |
020622 |
002 |
NDA |
COPAXONE |
GLATIRAMER ACETATE |
INJECTABLE;SUBCUTANEOUS |
20MG/ML |
Prescription |
Yes |
Yes |
AP |
2002/02/12
|
TEVA PHARMS USA |
090218 |
001 |
ANDA |
GLATOPA |
GLATIRAMER ACETATE |
INJECTABLE;SUBCUTANEOUS |
20MG/ML |
Prescription |
No |
No |
AP |
2015/04/16
|
SANDOZ |
091646 |
001 |
ANDA |
GLATIRAMER ACETATE |
GLATIRAMER ACETATE |
INJECTABLE;SUBCUTANEOUS |
20MG/ML |
Prescription |
No |
No |
AP |
2017/10/03
|
MYLAN |
活性成分:GLATIRAMER ACETATE 剂型/给药途径:INJECTABLE;SUBCUTANEOUS 规格:40MG/ML 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 |
020622 |
003 |
NDA |
COPAXONE |
GLATIRAMER ACETATE |
INJECTABLE;SUBCUTANEOUS |
40MG/ML |
Prescription |
Yes |
Yes |
AP |
2014/01/28
|
TEVA PHARMS USA |
206936 |
001 |
ANDA |
GLATIRAMER ACETATE |
GLATIRAMER ACETATE |
INJECTABLE;SUBCUTANEOUS |
40MG/ML |
Prescription |
No |
No |
AP |
2017/10/03
|
MYLAN |
206921 |
001 |
ANDA |
GLATOPA |
GLATIRAMER ACETATE |
INJECTABLE;SUBCUTANEOUS |
40MG/ML |
Prescription |
No |
No |
AP |
2018/02/12
|
SANDOZ |