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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
1948/11/19 0:00:00
ORIG
1
AP
UNKNOWN
1972/12/4 0:00:00
SUPPL
2
AP
Labeling
1974/5/20 0:00:00
SUPPL
5
AP
Manufacturing (CMC)
1974/6/24 0:00:00
SUPPL
6
AP
Supplement
1975/7/16 0:00:00
SUPPL
10
AP
Manufacturing (CMC)
1975/8/28 0:00:00
SUPPL
8
AP
Labeling
1975/8/28 0:00:00
SUPPL
9
AP
Manufacturing (CMC)
1975/10/9 0:00:00
SUPPL
11
AP
Labeling
1976/2/2 0:00:00
SUPPL
13
AP
Manufacturing (CMC)
1978/5/17 0:00:00
SUPPL
15
AP
Labeling
1979/2/27 0:00:00
SUPPL
19
AP
Manufacturing (CMC)
1979/3/26 0:00:00
SUPPL
16
AP
Manufacturing (CMC)
1979/4/9 0:00:00
SUPPL
17
AP
Manufacturing (CMC)
1979/4/9 0:00:00
SUPPL
18
AP
Labeling
1979/8/29 0:00:00
SUPPL
21
AP
Labeling
1980/4/17 0:00:00
SUPPL
22
AP
Manufacturing (CMC)
1980/12/31 0:00:00
SUPPL
20
AP
Labeling
1981/10/1 0:00:00
SUPPL
23
AP
Manufacturing (CMC)
1981/10/1 0:00:00
SUPPL
26
AP
Labeling
1982/3/25 0:00:00
SUPPL
30
AP
Manufacturing (CMC)
1982/6/28 0:00:00
SUPPL
31
AP
Manufacturing (CMC)
1982/7/26 0:00:00
SUPPL
24
AP
Manufacturing (CMC)
1982/7/26 0:00:00
SUPPL
25
AP
Labeling
1984/12/3 0:00:00
SUPPL
32
AP
Labeling
1984/12/12 0:00:00
SUPPL
27
AP
Labeling
1985/3/22 0:00:00
SUPPL
33
AP
Manufacturing (CMC)
1985/3/22 0:00:00
SUPPL
34
AP
Labeling
1986/2/22 0:00:00
SUPPL
28
AP
Manufacturing (CMC)
1986/2/22 0:00:00
SUPPL
29
AP
Labeling
1986/2/27 0:00:00
SUPPL
41
AP
Labeling
1986/5/19 0:00:00
SUPPL
42
AP
Labeling
1986/8/29 0:00:00
SUPPL
39
AP
Manufacturing (CMC)
1986/8/29 0:00:00
SUPPL
40
AP
Labeling
1986/11/13 0:00:00
SUPPL
37
AP
Manufacturing (CMC)
1986/11/13 0:00:00
SUPPL
38
AP
Labeling
1987/3/18 0:00:00
SUPPL
44
AP
Labeling
1987/9/11 0:00:00
SUPPL
45
AP
Manufacturing (CMC)
1987/9/11 0:00:00
SUPPL
46
AP
Labeling
1987/9/16 0:00:00
SUPPL
43
AP
Manufacturing (CMC)
1988/12/2 0:00:00
SUPPL
47
AP
Manufacturing (CMC)
1988/12/2 0:00:00
SUPPL
48
AP
Labeling
1989/7/11 0:00:00
SUPPL
49
AP
Manufacturing (CMC)
1990/10/2 0:00:00
SUPPL
50
AP
Manufacturing (CMC)
1991/3/21 0:00:00
SUPPL
35
AP
Manufacturing (CMC)
1991/3/21 0:00:00
SUPPL
36
AP
Labeling
1993/2/18 0:00:00
SUPPL
52
AP
Manufacturing (CMC)
1993/4/13 0:00:00
SUPPL
53
AP
Manufacturing (CMC)
1993/10/20 0:00:00
SUPPL
51
AP
Manufacturing (CMC)
1994/11/21 0:00:00
SUPPL
54
AP
Manufacturing (CMC)
1995/7/11 0:00:00
SUPPL
55
AP
Manufacturing (CMC)
1995/7/18 0:00:00
SUPPL
56
AP
Manufacturing (CMC)
1996/1/3 0:00:00
SUPPL
58
AP
Manufacturing (CMC)
1996/5/2 0:00:00
SUPPL
60
AP
Manufacturing (CMC)
1996/5/31 0:00:00
SUPPL
59
AP
Manufacturing (CMC)
1997/12/8 0:00:00
SUPPL
57
AP
Manufacturing (CMC)
1998/3/6 0:00:00
SUPPL
62
AP
Manufacturing (CMC)
1999/5/26 0:00:00
SUPPL
61
AP
Labeling
STANDARD
2000/12/8 0:00:00
SUPPL
65
AP
Manufacturing (CMC)
2000/12/14 0:00:00
SUPPL
64
AP
Manufacturing (CMC)
2002/7/17 0:00:00
SUPPL
66
AP
Manufacturing (CMC)
2010/2/19 0:00:00
SUPPL
74
AP
Labeling
901 REQUIRED
2013/2/13 0:00:00
SUPPL
85
AP
Manufacturing (CMC)
2013/2/16 0:00:00
SUPPL
83
AP
Manufacturing (CMC)
2013/2/20 0:00:00
SUPPL
86
AP
Manufacturing (CMC)
2013/3/28 0:00:00
SUPPL
84
AP
Labeling
STANDARD
2013/4/9 0:00:00
SUPPL
78
AP
Manufacturing (CMC)
2013/6/11 0:00:00
SUPPL
76
AP
Manufacturing (CMC)
2013/7/22 0:00:00
SUPPL
87
AP
Manufacturing (CMC)
2013/10/29 0:00:00
SUPPL
79
AP
Manufacturing (CMC)
2013/12/26 0:00:00
SUPPL
88
AP
Manufacturing (CMC)
2015/3/3 0:00:00
SUPPL
89
AP
Manufacturing (CMC)
2016/3/17 0:00:00
SUPPL
91
AP
Manufacturing (CMC)
2017/12/22 0:00:00
SUPPL
95
AP
Manufacturing (CMC)
STANDARD
2017/12/22 0:00:00
SUPPL
90
AP
Labeling
STANDARD
2018/11/2 0:00:00
SUPPL
97
AP
Labeling
STANDARD
2024/10/30 0:00:00
SUPPL
100
AP
Labeling
STANDARD
2010-03-18 00:00:00
SUPPL
74
AP
2010-02-25 00:00:00
SUPPL
74
AP
2012-01-27 00:00:00
SUPPL
19
AP
2017-12-29 00:00:00
SUPPL
95
AP
2017-12-29 00:00:00
SUPPL
90
AP
2018-01-12 00:00:00
SUPPL
95
AP
2018-01-12 00:00:00
SUPPL
90
AP
2018-11-02 00:00:00
SUPPL
97
AP
2018-11-06 00:00:00
SUPPL
97
AP
2019-02-01 00:00:00
SUPPL
27
AP
2024-12-02 00:00:00
SUPPL
100
AP
2024-11-01 00:00:00
SUPPL
100
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