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HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.45%--
产品信息
商品名
TEcode
产品号
申请类型
活性成分
剂型/给药途径
规格/剂量
是否参比药物
是否生物等效
批准历史，通知信，药品说明书，综述等审批信息
批准日期
申请类型
申请提交号
审查批准结论
申请内容分类
审评分类（优先审评;罕用药状态）
通知信、综述、标签、说明书
备注
1984/1/31 0:00:00
ORIG
1
AP
Type 5 - New Formulation or New Manufacturer
STANDARD
1984/9/24 0:00:00
SUPPL
1
AP
Labeling
1985/4/16 0:00:00
SUPPL
2
AP
Manufacturing (CMC)
STANDARD
1985/10/29 0:00:00
SUPPL
4
AP
Manufacturing (CMC)
STANDARD
1985/10/29 0:00:00
SUPPL
3
AP
Manufacturing (CMC)
STANDARD
1986/8/8 0:00:00
SUPPL
5
AP
Manufacturing (CMC)
STANDARD
1986/10/29 0:00:00
SUPPL
6
AP
Manufacturing (CMC)
STANDARD
1987/8/21 0:00:00
SUPPL
7
AP
Manufacturing (CMC)
STANDARD
1988/10/24 0:00:00
SUPPL
12
AP
Labeling
1989/6/23 0:00:00
SUPPL
8
AP
Efficacy
1990/2/16 0:00:00
SUPPL
15
AP
Manufacturing (CMC)
STANDARD
1990/10/29 0:00:00
SUPPL
16
AP
Manufacturing (CMC)
STANDARD
1991/10/2 0:00:00
SUPPL
21
AP
Labeling
1992/2/18 0:00:00
SUPPL
18
AP
Manufacturing (CMC)
STANDARD
1992/2/25 0:00:00
SUPPL
20
AP
Manufacturing (CMC)
STANDARD
1996/2/7 0:00:00
SUPPL
25
AP
Manufacturing (CMC)
STANDARD
1996/8/29 0:00:00
SUPPL
26
AP
Manufacturing (CMC)
STANDARD
1996/8/30 0:00:00
SUPPL
23
AP
Manufacturing (CMC)
STANDARD
1996/9/5 0:00:00
SUPPL
24
AP
Manufacturing (CMC)
STANDARD
1997/4/3 0:00:00
SUPPL
27
AP
Manufacturing (CMC)
STANDARD
1997/6/9 0:00:00
SUPPL
29
AP
Manufacturing (CMC)
STANDARD
1997/6/25 0:00:00
SUPPL
30
AP
Manufacturing (CMC)
STANDARD
1997/8/29 0:00:00
SUPPL
31
AP
Manufacturing (CMC)
STANDARD
1998/8/25 0:00:00
SUPPL
28
AP
Labeling
STANDARD
1998/10/27 0:00:00
SUPPL
32
AP
Manufacturing (CMC)
STANDARD
1999/11/19 0:00:00
SUPPL
33
AP
Labeling
STANDARD
2011/12/23 0:00:00
SUPPL
57
AP
Labeling
STANDARD
2012/11/30 0:00:00
SUPPL
59
AP
Manufacturing (CMC)
STANDARD
2013/2/8 0:00:00
SUPPL
61
AP
Manufacturing (CMC)
STANDARD
2013/2/12 0:00:00
SUPPL
60
AP
Labeling
STANDARD
2013/7/15 0:00:00
SUPPL
62
AP
Manufacturing (CMC)
STANDARD
2014/1/15 0:00:00
SUPPL
64
AP
Manufacturing (CMC)
STANDARD
2015/3/3 0:00:00
SUPPL
67
AP
Manufacturing (CMC)
STANDARD
2015/4/14 0:00:00
SUPPL
68
AP
Manufacturing (CMC)
STANDARD
2016/4/5 0:00:00
SUPPL
66
AP
Labeling
STANDARD
2016/4/5 0:00:00
SUPPL
69
AP
Labeling
STANDARD
2016/7/18 0:00:00
SUPPL
70
AP
Manufacturing (CMC)
STANDARD
2019/9/4 0:00:00
SUPPL
63
AP
Labeling
STANDARD
2020/7/30 0:00:00
SUPPL
71
AP
Labeling
STANDARD
2024/10/24 0:00:00
SUPPL
79
AP
Labeling
STANDARD
2024/12/10 0:00:00
SUPPL
80
AP
Labeling
STANDARD
2025/11/19 0:00:00
SUPPL
83
AP
Labeling
STANDARD
2013-02-13 00:00:00
SUPPL
60
AP
2016-04-07 00:00:00
SUPPL
66
AP
2011-12-23 00:00:00
SUPPL
57
AP
2011-12-29 00:00:00
SUPPL
57
AP
2016-04-07 00:00:00
SUPPL
69
AP
2013-02-14 00:00:00
SUPPL
60
AP
2016-04-12 00:00:00
SUPPL
66
AP
2016-04-12 00:00:00
SUPPL
69
AP
2019-09-05 00:00:00
SUPPL
63
AP
2019-09-05 00:00:00
SUPPL
63
AP
2020-08-13 00:00:00
SUPPL
71
AP
2020-08-03 00:00:00
SUPPL
71
AP
2024-10-25 00:00:00
SUPPL
79
AP
2024-10-28 00:00:00
SUPPL
79
AP
2024-12-11 00:00:00
SUPPL
80
AP
2024-12-13 00:00:00
SUPPL
80
AP
2025-11-21 00:00:00
SUPPL
83
AP
2025-11-26 00:00:00
SUPPL
83
AP
与本品相关的专利信息（来自FDA橙皮书Orange Book）
类型
关联产品号
专利号
专利过期日
中否物质专利
是否产品专利
专利用途代码
退市请求
与本品治疗等效的药品
申请号
商品名
TEcode
产品号
申请类型
活性成分
剂型/给药途径
规格/剂量
是否参比药物
是否生物等效