当前位置：药药网 / 药品 / 美国FDA药品数据库详细
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
1946/11/19 0:00:00
ORIG
1
AP
UNKNOWN
1975/5/20 0:00:00
SUPPL
10
AP
Manufacturing (CMC)
1975/5/20 0:00:00
SUPPL
11
AP
Manufacturing (CMC)
1976/1/16 0:00:00
SUPPL
12
AP
Manufacturing (CMC)
1976/5/3 0:00:00
SUPPL
13
AP
Manufacturing (CMC)
1977/6/9 0:00:00
SUPPL
16
AP
Manufacturing (CMC)
1979/1/16 0:00:00
SUPPL
18
AP
Manufacturing (CMC)
1979/1/23 0:00:00
SUPPL
19
AP
Efficacy
1979/5/15 0:00:00
SUPPL
20
AP
Efficacy
1980/7/22 0:00:00
SUPPL
21
AP
Efficacy
1981/6/15 0:00:00
SUPPL
25
AP
Manufacturing (CMC)
1981/6/17 0:00:00
SUPPL
22
AP
Efficacy
1981/6/17 0:00:00
SUPPL
24
AP
Manufacturing (CMC)
1981/9/28 0:00:00
SUPPL
23
AP
Manufacturing (CMC)
1984/8/30 0:00:00
SUPPL
30
AP
Manufacturing (CMC)
1984/10/22 0:00:00
SUPPL
29
AP
Manufacturing (CMC)
1985/5/14 0:00:00
SUPPL
33
AP
Manufacturing (CMC)
1985/6/18 0:00:00
SUPPL
32
AP
Manufacturing (CMC)
1985/9/30 0:00:00
SUPPL
31
AP
Labeling
1986/1/7 0:00:00
SUPPL
34
AP
Labeling
1987/5/6 0:00:00
SUPPL
37
AP
Labeling
1987/7/6 0:00:00
SUPPL
36
AP
Manufacturing (CMC)
1989/3/2 0:00:00
SUPPL
42
AP
Manufacturing (CMC)
1989/10/20 0:00:00
SUPPL
43
AP
Manufacturing (CMC)
1989/10/20 0:00:00
SUPPL
44
AP
Manufacturing (CMC)
1989/10/20 0:00:00
SUPPL
46
AP
Manufacturing (CMC)
1989/10/20 0:00:00
SUPPL
47
AP
Manufacturing (CMC)
1990/9/6 0:00:00
SUPPL
48
AP
Manufacturing (CMC)
1991/5/28 0:00:00
SUPPL
49
AP
Labeling
1993/3/11 0:00:00
SUPPL
53
AP
Manufacturing (CMC)
1994/4/25 0:00:00
SUPPL
52
AP
Labeling
STANDARD
1994/7/7 0:00:00
SUPPL
54
AP
Manufacturing (CMC)
1994/7/18 0:00:00
SUPPL
51
AP
Manufacturing (CMC)
1995/3/22 0:00:00
SUPPL
50
AP
Labeling
1995/9/22 0:00:00
SUPPL
55
AP
Manufacturing (CMC)
1995/9/22 0:00:00
SUPPL
56
AP
Manufacturing (CMC)
1995/10/17 0:00:00
SUPPL
57
AP
Manufacturing (CMC)
1996/2/21 0:00:00
SUPPL
59
AP
Manufacturing (CMC)
1996/2/22 0:00:00
SUPPL
58
AP
Labeling
STANDARD
1997/5/27 0:00:00
SUPPL
60
AP
Labeling
STANDARD
1997/7/15 0:00:00
SUPPL
61
AP
Manufacturing (CMC)
1999/4/22 0:00:00
SUPPL
62
AP
Manufacturing (CMC)
1999/12/9 0:00:00
SUPPL
63
AP
Manufacturing (CMC)
2000/4/14 0:00:00
SUPPL
64
AP
Manufacturing (CMC)
2001/4/3 0:00:00
SUPPL
66
AP
Manufacturing (CMC)
2001/5/22 0:00:00
SUPPL
65
AP
Manufacturing (CMC)
2002/1/28 0:00:00
SUPPL
67
AP
Manufacturing (CMC)
2002/2/5 0:00:00
SUPPL
68
AP
Manufacturing (CMC)
2002/2/5 0:00:00
SUPPL
69
AP
Manufacturing (CMC)
2003/10/1 0:00:00
SUPPL
73
AP
Labeling
STANDARD
2004/2/18 0:00:00
SUPPL
72
AP
Labeling
STANDARD
2007/4/26 0:00:00
SUPPL
75
AP
Labeling
STANDARD
2012/6/25 0:00:00
SUPPL
78
AP
Labeling
UNKNOWN
2013/5/21 0:00:00
SUPPL
79
AP
Manufacturing (CMC)
2025/5/29 0:00:00
SUPPL
80
AP
Labeling
STANDARD
2004-03-02 00:00:00
SUPPL
72
AP
2003-10-09 00:00:00
SUPPL
73
AP
2007-05-01 00:00:00
SUPPL
75
AP
2012-06-27 00:00:00
SUPPL
78
AP
2012-06-25 00:00:00
SUPPL
78
AP
2007-05-01 00:00:00
SUPPL
75
AP
2013-01-28 00:00:00
SUPPL
78
AP
2025-05-30 00:00:00
SUPPL
80
AP
2025-05-30 00:00:00
SUPPL
80
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