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 |
2023/11/27 |
SUPPL-136(补充) |
Approval |
Manufacturing (CMC) |
N/A
|
|
|
2023/11/16 |
SUPPL-138(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2022/05/02 |
SUPPL-135(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2021/03/29 |
SUPPL-131(补充) |
Approval |
Efficacy |
STANDARD
|
|
|
2018/05/07 |
SUPPL-125(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2018/03/15 |
SUPPL-126(补充) |
Approval |
Labeling |
901 REQUIRED
|
|
|
2016/02/03 |
SUPPL-124(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2015/11/20 |
SUPPL-122(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2015/08/14 |
SUPPL-121(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2011/11/01 |
SUPPL-117(补充) |
Approval |
Labeling |
901 REQUIRED
|
|
|
2005/04/13 |
SUPPL-108(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2004/12/15 |
SUPPL-107(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2004/01/27 |
SUPPL-106(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2003/07/29 |
SUPPL-105(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2003/01/03 |
SUPPL-104(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2002/02/20 |
SUPPL-103(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2002/02/20 |
SUPPL-102(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2001/05/08 |
SUPPL-100(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2000/11/08 |
SUPPL-96(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1999/10/29 |
SUPPL-99(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1999/02/12 |
SUPPL-98(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1998/06/22 |
SUPPL-97(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1997/05/20 |
SUPPL-95(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1995/04/25 |
SUPPL-94(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1992/01/23 |
SUPPL-89(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1991/11/05 |
SUPPL-86(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1991/02/20 |
SUPPL-83(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1990/10/24 |
SUPPL-85(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1990/01/18 |
SUPPL-76(补充) |
Approval |
Labeling |
|
|
|
1989/03/01 |
SUPPL-81(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1988/04/21 |
SUPPL-79(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1988/04/07 |
SUPPL-78(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1988/04/07 |
SUPPL-77(补充) |
Approval |
Efficacy |
|
|
|
1987/08/18 |
SUPPL-74(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1987/03/19 |
SUPPL-70(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1986/12/08 |
SUPPL-75(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1986/09/16 |
SUPPL-73(补充) |
Approval |
Labeling |
|
|
|
1986/09/16 |
SUPPL-71(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1983/04/08 |
SUPPL-63(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1983/04/08 |
SUPPL-59(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1982/08/24 |
SUPPL-62(补充) |
Approval |
Labeling |
|
|
|
1982/03/31 |
SUPPL-58(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1982/03/31 |
SUPPL-57(补充) |
Approval |
Labeling |
|
|
|
1981/12/07 |
SUPPL-56(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1981/05/11 |
SUPPL-54(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1980/12/03 |
SUPPL-53(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1980/06/11 |
SUPPL-50(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1980/02/29 |
SUPPL-52(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1979/10/15 |
SUPPL-51(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1979/02/15 |
SUPPL-49(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1979/01/02 |
SUPPL-43(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1978/12/14 |
SUPPL-47(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1978/08/22 |
SUPPL-39(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1978/08/08 |
SUPPL-46(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1977/08/02 |
SUPPL-35(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1977/07/14 |
SUPPL-38(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1977/03/28 |
SUPPL-36(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1977/03/18 |
SUPPL-37(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1976/09/14 |
SUPPL-33(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1976/09/14 |
SUPPL-32(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1976/09/07 |
SUPPL-31(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1976/09/07 |
SUPPL-30(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1976/09/07 |
SUPPL-29(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1976/08/03 |
SUPPL-27(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1976/06/29 |
SUPPL-28(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1976/06/29 |
SUPPL-26(补充) |
Approval |
Labeling |
|
|
|
1976/06/29 |
SUPPL-25(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1975/12/05 |
SUPPL-24(补充) |
Approval |
Labeling |
|
|
|
1975/11/03 |
SUPPL-23(补充) |
Approval |
Labeling |
|
|
|
1975/11/03 |
SUPPL-22(补充) |
Approval |
Labeling |
|
|
|
1975/07/22 |
SUPPL-21(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1959/08/10 |
ORIG-1(原始申请) |
Approval |
Type 2 - New Active Ingredient |
STANDARD
;Orphan
|
|
|
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:METHOTREXATE SODIUM 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 50MG BASE/2ML (EQ 25MG BASE/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 |
040850 |
001 |
|
METHOTREXATE SODIUM PRESERVATIVE FREE |
METHOTREXATE SODIUM |
INJECTABLE;INJECTION |
EQ 50MG BASE/2ML (EQ 25MG BASE/ML) |
Prescription |
No |
No |
AP |
--
|
|
089340 |
001 |
ANDA |
METHOTREXATE SODIUM PRESERVATIVE FREE |
METHOTREXATE SODIUM |
INJECTABLE;INJECTION |
EQ 50MG BASE/2ML (EQ 25MG BASE/ML) |
Prescription |
No |
Yes |
AP |
1986/09/16
|
HIKMA |
040263 |
001 |
ANDA |
METHOTREXATE SODIUM |
METHOTREXATE SODIUM |
INJECTABLE;INJECTION |
EQ 50MG BASE/2ML (EQ 25MG BASE/ML) |
Prescription |
No |
Yes |
AP |
1999/02/26
|
FRESENIUS KABI USA |
011719 |
010 |
NDA |
METHOTREXATE SODIUM |
METHOTREXATE SODIUM |
INJECTABLE;INJECTION |
EQ 50MG BASE/2ML (EQ 25MG BASE/ML) |
Prescription |
Yes |
Yes |
AP |
2004/12/15
|
HOSPIRA |
040767 |
001 |
ANDA |
METHOTREXATE SODIUM PRESERVATIVE FREE |
METHOTREXATE SODIUM |
INJECTABLE;INJECTION |
EQ 50MG BASE/2ML (EQ 25MG BASE/ML) |
Prescription |
No |
Yes |
AP |
2007/04/30
|
ACCORD HLTHCARE |
090039 |
001 |
ANDA |
METHOTREXATE SODIUM PRESERVATIVE FREE |
METHOTREXATE SODIUM |
INJECTABLE;INJECTION |
EQ 50MG BASE/2ML (EQ 25MG BASE/ML) |
Prescription |
No |
No |
AP |
2009/03/31
|
SANDOZ |
040843 |
002 |
ANDA |
METHOTREXATE SODIUM PRESERVATIVE FREE |
METHOTREXATE SODIUM |
INJECTABLE;INJECTION |
EQ 50MG BASE/2ML (EQ 25MG BASE/ML) |
Prescription |
No |
No |
AP |
2010/01/11
|
PHARMACHEMIE BV |
203407 |
001 |
ANDA |
METHOTREXATE SODIUM PRESERVATIVE FREE |
METHOTREXATE SODIUM |
INJECTABLE;INJECTION |
EQ 50MG BASE/2ML (EQ 25MG BASE/ML) |
Prescription |
No |
No |
AP |
2018/08/09
|
SAGENT PHARMS INC |
活性成分:METHOTREXATE SODIUM 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 1GM BASE/40ML (EQ 25MG BASE/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 |
011719 |
012 |
NDA |
METHOTREXATE SODIUM PRESERVATIVE FREE |
METHOTREXATE SODIUM |
INJECTABLE;INJECTION |
EQ 1GM BASE/40ML (EQ 25MG BASE/ML) |
Prescription |
Yes |
Yes |
AP |
2005/04/13
|
HOSPIRA |
040716 |
001 |
ANDA |
METHOTREXATE SODIUM PRESERVATIVE FREE |
METHOTREXATE SODIUM |
INJECTABLE;INJECTION |
EQ 1GM BASE/40ML (EQ 25MG BASE/ML) |
Prescription |
No |
Yes |
AP |
2007/04/30
|
ACCORD HLTHCARE |
090029 |
001 |
ANDA |
METHOTREXATE SODIUM PRESERVATIVE FREE |
METHOTREXATE SODIUM |
INJECTABLE;INJECTION |
EQ 1GM BASE/40ML (EQ 25MG BASE/ML) |
Prescription |
No |
No |
AP |
2009/03/31
|
SANDOZ |
040843 |
001 |
ANDA |
METHOTREXATE SODIUM PRESERVATIVE FREE |
METHOTREXATE SODIUM |
INJECTABLE;INJECTION |
EQ 1GM BASE/40ML (EQ 25MG BASE/ML) |
Prescription |
No |
No |
AP |
2010/01/11
|
PHARMACHEMIE BV |
203407 |
003 |
ANDA |
METHOTREXATE SODIUM PRESERVATIVE FREE |
METHOTREXATE SODIUM |
INJECTABLE;INJECTION |
EQ 1GM BASE/40ML (EQ 25MG BASE/ML) |
Prescription |
No |
No |
AP |
2018/08/09
|
SAGENT PHARMS INC |