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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
1978/2/10 0:00:00
ORIG
1
AP
Type 5 - New Formulation or New Manufacturer
STANDARD
1978/11/15 0:00:00
SUPPL
1
AP
Manufacturing (CMC)
STANDARD
1979/1/8 0:00:00
SUPPL
2
AP
Manufacturing (CMC)
STANDARD
1979/1/8 0:00:00
SUPPL
6
AP
Manufacturing (CMC)
STANDARD
1979/1/8 0:00:00
SUPPL
4
AP
Labeling
1979/5/29 0:00:00
SUPPL
7
AP
Manufacturing (CMC)
STANDARD
1979/7/13 0:00:00
SUPPL
3
AP
Manufacturing (CMC)
STANDARD
1979/9/18 0:00:00
SUPPL
9
AP
Manufacturing (CMC)
STANDARD
1979/10/3 0:00:00
SUPPL
5
AP
Manufacturing (CMC)
STANDARD
1979/10/18 0:00:00
SUPPL
10
AP
Manufacturing (CMC)
STANDARD
1980/1/21 0:00:00
SUPPL
11
AP
Labeling
1980/1/25 0:00:00
SUPPL
8
AP
Labeling
1981/6/2 0:00:00
SUPPL
12
AP
Manufacturing (CMC)
STANDARD
1982/4/6 0:00:00
SUPPL
13
AP
Manufacturing (CMC)
STANDARD
1983/1/12 0:00:00
SUPPL
14
AP
Manufacturing (CMC)
STANDARD
1983/12/19 0:00:00
SUPPL
15
AP
Efficacy
1984/6/26 0:00:00
SUPPL
16
AP
Efficacy
1984/9/19 0:00:00
SUPPL
19
AP
Manufacturing (CMC)
STANDARD
1984/10/4 0:00:00
SUPPL
18
AP
Labeling
1985/1/8 0:00:00
SUPPL
21
AP
Manufacturing (CMC)
STANDARD
1985/7/29 0:00:00
SUPPL
20
AP
Labeling
1988/10/19 0:00:00
SUPPL
22
AP
Labeling
1989/2/9 0:00:00
SUPPL
23
AP
Labeling
1992/7/31 0:00:00
SUPPL
30
AP
Labeling
1992/12/22 0:00:00
SUPPL
31
AP
Labeling
STANDARD
1993/8/25 0:00:00
SUPPL
25
AP
Labeling
1995/7/12 0:00:00
SUPPL
29
AP
Manufacturing (CMC)
STANDARD
1996/7/26 0:00:00
SUPPL
26
AP
Manufacturing (CMC)
STANDARD
1997/12/22 0:00:00
SUPPL
32
AP
Manufacturing (CMC)
STANDARD
1999/12/13 0:00:00
SUPPL
33
AP
Manufacturing (CMC)
STANDARD
2003/1/7 0:00:00
SUPPL
35
AP
Manufacturing (CMC)
STANDARD
2007/12/14 0:00:00
SUPPL
42
AP
Labeling
STANDARD
2009/4/1 0:00:00
SUPPL
46
AP
Labeling
STANDARD
2010/6/11 0:00:00
SUPPL
48
AP
Labeling
UNKNOWN
2011/6/24 0:00:00
SUPPL
52
AP
Labeling
STANDARD
2011/12/23 0:00:00
SUPPL
55
AP
Labeling
STANDARD
2013/2/16 0:00:00
SUPPL
56
AP
Manufacturing (CMC)
STANDARD
2013/3/20 0:00:00
SUPPL
57
AP
Manufacturing (CMC)
STANDARD
2013/7/18 0:00:00
SUPPL
60
AP
Manufacturing (CMC)
STANDARD
2014/3/21 0:00:00
SUPPL
59
AP
Labeling
STANDARD
2015/11/13 0:00:00
SUPPL
58
AP
Manufacturing (CMC)
STANDARD
2016/11/15 0:00:00
SUPPL
62
AP
Manufacturing (CMC)
STANDARD
2020/7/2 0:00:00
SUPPL
66
AP
Labeling
STANDARD
2021/6/7 0:00:00
SUPPL
69
AP
Labeling
STANDARD
2024/10/24 0:00:00
SUPPL
78
AP
Labeling
STANDARD
2009-04-03 00:00:00
SUPPL
46
AP
2011-07-05 00:00:00
SUPPL
52
AP
2011-12-29 00:00:00
SUPPL
55
AP
2014-04-07 00:00:00
SUPPL
59
AP
2010-06-24 00:00:00
SUPPL
48
AP
2008-01-09 00:00:00
SUPPL
42
AP
2010-06-14 00:00:00
SUPPL
48
AP
2007-07-20 00:00:00
ORIG
1
AP
2009-04-03 00:00:00
SUPPL
46
AP
2011-12-23 00:00:00
SUPPL
55
AP
2020-07-06 00:00:00
SUPPL
66
AP
2020-07-06 00:00:00
SUPPL
66
AP
2021-06-08 00:00:00
SUPPL
69
AP
2024-10-25 00:00:00
SUPPL
78
AP
2024-10-28 00:00:00
SUPPL
78
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