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 |
2024/07/24 |
SUPPL-185(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2019/05/29 |
SUPPL-169(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2018/03/09 |
SUPPL-160(补充) |
Approval |
Manufacturing (CMC) |
N/A
|
|
|
2016/03/03 |
SUPPL-151(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2015/05/13 |
SUPPL-150(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2014/12/22 |
SUPPL-148(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2014/06/05 |
SUPPL-149(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/09/11 |
SUPPL-147(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2005/08/26 |
SUPPL-139(补充) |
Approval |
Supplement |
STANDARD
|
|
|
2005/05/23 |
SUPPL-137(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2003/07/17 |
SUPPL-131(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2002/09/16 |
SUPPL-128(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2002/04/03 |
SUPPL-124(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2001/08/14 |
SUPPL-126(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1999/11/24 |
SUPPL-125(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1997/12/31 |
SUPPL-123(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1997/06/10 |
SUPPL-121(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1997/04/29 |
SUPPL-122(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1996/11/14 |
SUPPL-119(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1996/10/11 |
SUPPL-120(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1995/09/27 |
SUPPL-118(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1994/09/30 |
SUPPL-116(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1994/02/18 |
SUPPL-117(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1993/06/01 |
SUPPL-111(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1993/01/06 |
SUPPL-115(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1992/11/23 |
SUPPL-110(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1991/03/26 |
SUPPL-109(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1991/02/15 |
SUPPL-106(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1990/05/24 |
SUPPL-108(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1990/03/23 |
SUPPL-107(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1989/07/26 |
SUPPL-105(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1989/01/12 |
SUPPL-104(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1989/01/10 |
SUPPL-102(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1988/06/14 |
SUPPL-103(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1987/07/25 |
SUPPL-100(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1987/05/28 |
SUPPL-99(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1987/04/27 |
SUPPL-101(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1986/02/27 |
SUPPL-96(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1985/10/30 |
SUPPL-89(补充) |
Approval |
Labeling |
|
|
|
1985/10/30 |
SUPPL-88(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1985/08/28 |
SUPPL-83(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1985/08/28 |
SUPPL-82(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1985/06/13 |
SUPPL-91(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1985/04/15 |
SUPPL-95(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1985/04/15 |
SUPPL-94(补充) |
Approval |
Labeling |
|
|
|
1985/01/24 |
SUPPL-80(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1984/09/22 |
SUPPL-90(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1984/09/21 |
SUPPL-87(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1984/03/16 |
SUPPL-81(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1984/02/28 |
SUPPL-86(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1983/07/11 |
SUPPL-75(补充) |
Approval |
Labeling |
|
|
|
1982/06/03 |
SUPPL-72(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1982/04/16 |
SUPPL-70(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1982/04/08 |
SUPPL-77(补充) |
Approval |
Labeling |
|
|
|
1982/02/16 |
SUPPL-76(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1981/12/21 |
SUPPL-68(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1981/11/20 |
SUPPL-74(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1981/11/09 |
SUPPL-71(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1981/08/26 |
SUPPL-69(补充) |
Approval |
Labeling |
|
|
|
1981/08/06 |
SUPPL-61(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1981/06/29 |
SUPPL-64(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1981/05/20 |
SUPPL-67(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1981/04/23 |
SUPPL-65(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1981/04/16 |
SUPPL-60(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1981/01/21 |
SUPPL-63(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1980/08/07 |
SUPPL-54(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1980/07/31 |
SUPPL-62(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1980/06/28 |
SUPPL-52(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1980/06/18 |
SUPPL-58(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1980/05/30 |
SUPPL-57(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1980/05/30 |
SUPPL-56(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1980/02/25 |
SUPPL-41(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1980/02/22 |
SUPPL-55(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1979/08/02 |
SUPPL-51(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1979/03/23 |
SUPPL-50(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1978/11/03 |
SUPPL-44(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1978/10/20 |
SUPPL-47(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1978/09/08 |
SUPPL-48(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1978/08/07 |
SUPPL-46(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1978/08/02 |
SUPPL-45(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1978/06/20 |
SUPPL-40(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1978/04/25 |
SUPPL-43(补充) |
Approval |
Labeling |
|
|
|
1978/03/24 |
SUPPL-39(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1978/03/22 |
SUPPL-42(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1978/02/28 |
SUPPL-38(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1978/01/11 |
SUPPL-34(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1978/01/11 |
SUPPL-33(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1978/01/11 |
SUPPL-29(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1977/12/14 |
SUPPL-37(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1977/06/06 |
SUPPL-36(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1977/02/07 |
SUPPL-35(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1976/10/20 |
SUPPL-22(补充) |
Approval |
Labeling |
|
|
|
1976/10/18 |
SUPPL-32(补充) |
Approval |
Labeling |
|
|
|
1976/07/13 |
SUPPL-31(补充) |
Approval |
Labeling |
|
|
|
1976/07/01 |
SUPPL-25(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1976/06/17 |
SUPPL-28(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1976/05/11 |
SUPPL-20(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1976/01/05 |
SUPPL-24(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1976/01/02 |
SUPPL-26(补充) |
Approval |
Labeling |
|
|
|
1975/09/25 |
SUPPL-18(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1975/09/23 |
SUPPL-21(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1975/09/17 |
SUPPL-19(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1975/07/10 |
SUPPL-16(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1970/12/09 |
ORIG-1(原始申请) |
Approval |
Type 5 - New Formulation or New Manufacturer |
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:SODIUM CHLORIDE 剂型/给药途径:SOLUTION;INJECTION 规格:900MG/100ML 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 |
016677 |
001 |
NDA |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
SODIUM CHLORIDE |
SOLUTION;INJECTION |
900MG/100ML |
Prescription |
Yes |
Yes |
AP |
Approved Prior to Jan 1, 1982
|
BAXTER HLTHCARE |
019465 |
001 |
NDA |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
SODIUM CHLORIDE |
SOLUTION;INJECTION |
900MG/100ML |
Prescription |
Yes |
Yes |
AP |
1985/07/15
|
HOSPIRA |
020178 |
001 |
NDA |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
SODIUM CHLORIDE |
SOLUTION;INJECTION |
900MG/100ML |
Prescription |
Yes |
Yes |
AP |
1992/12/07
|
BAXTER HLTHCARE |
211968 |
002 |
ANDA |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
SODIUM CHLORIDE |
SOLUTION;INJECTION |
900MG/100ML |
Prescription |
No |
No |
AP |
2020/04/23
|
NEPHRON |
活性成分:SODIUM CHLORIDE 剂型/给药途径:SOLUTION;INJECTION 规格:450MG/50ML (9MG/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 |
016677 |
003 |
NDA |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
SODIUM CHLORIDE |
SOLUTION;INJECTION |
450MG/50ML (9MG/ML) |
Prescription |
Yes |
Yes |
AP |
Approved Prior to Jan 1, 1982
|
BAXTER HLTHCARE |
018803 |
003 |
NDA |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
SODIUM CHLORIDE |
SOLUTION;INJECTION |
450MG/50ML (9MG/ML) |
Prescription |
Yes |
Yes |
AP |
1982/10/29
|
HOSPIRA |
019465 |
002 |
NDA |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
SODIUM CHLORIDE |
SOLUTION;INJECTION |
450MG/50ML (9MG/ML) |
Prescription |
Yes |
No |
AP |
1985/07/15
|
HOSPIRA |
020178 |
002 |
NDA |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
SODIUM CHLORIDE |
SOLUTION;INJECTION |
450MG/50ML (9MG/ML) |
Prescription |
Yes |
No |
AP |
1992/12/07
|
BAXTER HLTHCARE |
211968 |
001 |
ANDA |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
SODIUM CHLORIDE |
SOLUTION;INJECTION |
450MG/50ML (9MG/ML) |
Prescription |
No |
No |
AP |
2020/04/23
|
NEPHRON |