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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
1942/11/10 0:00:00
ORIG
1
AP
Type 1 - New Molecular Entity
STANDARD
1974/1/18 0:00:00
SUPPL
4
AP
Labeling
1976/5/4 0:00:00
SUPPL
8
AP
Labeling
1976/8/10 0:00:00
SUPPL
9
AP
Manufacturing (CMC)
STANDARD
1977/12/2 0:00:00
SUPPL
11
AP
Manufacturing (CMC)
STANDARD
1978/1/4 0:00:00
SUPPL
10
AP
Manufacturing (CMC)
STANDARD
1978/7/21 0:00:00
SUPPL
13
AP
Labeling
1978/7/27 0:00:00
SUPPL
12
AP
Labeling
1979/7/26 0:00:00
SUPPL
14
AP
Labeling
1982/9/7 0:00:00
SUPPL
17
AP
Manufacturing (CMC)
STANDARD
1983/3/28 0:00:00
SUPPL
18
AP
Manufacturing (CMC)
STANDARD
1983/3/28 0:00:00
SUPPL
19
AP
Manufacturing (CMC)
STANDARD
1983/3/28 0:00:00
SUPPL
20
AP
Manufacturing (CMC)
STANDARD
1983/3/28 0:00:00
SUPPL
21
AP
Manufacturing (CMC)
STANDARD
1983/3/28 0:00:00
SUPPL
22
AP
Labeling
1983/3/28 0:00:00
SUPPL
23
AP
Manufacturing (CMC)
STANDARD
1984/1/17 0:00:00
SUPPL
24
AP
Manufacturing (CMC)
STANDARD
1985/5/20 0:00:00
SUPPL
25
AP
Manufacturing (CMC)
STANDARD
1985/5/20 0:00:00
SUPPL
26
AP
Manufacturing (CMC)
STANDARD
1985/6/4 0:00:00
SUPPL
27
AP
Manufacturing (CMC)
STANDARD
1986/5/12 0:00:00
SUPPL
28
AP
Manufacturing (CMC)
STANDARD
1986/7/18 0:00:00
SUPPL
29
AP
Labeling
1988/1/6 0:00:00
SUPPL
30
AP
Labeling
1989/4/3 0:00:00
SUPPL
32
AP
Manufacturing (CMC)
STANDARD
1989/5/24 0:00:00
SUPPL
34
AP
Manufacturing (CMC)
STANDARD
1989/5/25 0:00:00
SUPPL
33
AP
Manufacturing (CMC)
STANDARD
1990/1/25 0:00:00
SUPPL
35
AP
Manufacturing (CMC)
STANDARD
1990/9/12 0:00:00
SUPPL
36
AP
Manufacturing (CMC)
STANDARD
1991/2/12 0:00:00
SUPPL
37
AP
Manufacturing (CMC)
STANDARD
1992/7/30 0:00:00
SUPPL
38
AP
Manufacturing (CMC)
STANDARD
1992/9/10 0:00:00
SUPPL
41
AP
Manufacturing (CMC)
STANDARD
1992/9/29 0:00:00
SUPPL
39
AP
Manufacturing (CMC)
STANDARD
1992/9/29 0:00:00
SUPPL
40
AP
Manufacturing (CMC)
STANDARD
1995/3/16 0:00:00
SUPPL
42
AP
Manufacturing (CMC)
STANDARD
1995/3/16 0:00:00
SUPPL
43
AP
Manufacturing (CMC)
STANDARD
1995/3/16 0:00:00
SUPPL
44
AP
Manufacturing (CMC)
STANDARD
1995/10/10 0:00:00
SUPPL
45
AP
Manufacturing (CMC)
STANDARD
1997/7/24 0:00:00
SUPPL
31
AP
Labeling
2000/10/17 0:00:00
SUPPL
46
AP
Manufacturing (CMC)
STANDARD
2003/2/26 0:00:00
SUPPL
47
AP
Labeling
STANDARD
2003/5/15 0:00:00
SUPPL
48
AP
Labeling
STANDARD
2009/3/5 0:00:00
SUPPL
49
AP
Labeling
STANDARD
2011/4/11 0:00:00
SUPPL
50
AP
Labeling
STANDARD
2011/10/31 0:00:00
SUPPL
51
AP
Labeling
STANDARD
2016/12/16 0:00:00
SUPPL
54
AP
Labeling
STANDARD
2017/8/16 0:00:00
SUPPL
55
AP
Labeling
STANDARD
2018/9/18 0:00:00
SUPPL
56
AP
REMS
N/A
2018/9/18 0:00:00
SUPPL
57
AP
Labeling
STANDARD
2019/10/7 0:00:00
SUPPL
58
AP
Labeling
STANDARD
2021/3/4 0:00:00
SUPPL
59
AP
Labeling
STANDARD
2023/12/15 0:00:00
SUPPL
60
AP
Labeling
STANDARD
2024/10/31 0:00:00
SUPPL
61
AP
REMS
N/A
2025/12/22 0:00:00
SUPPL
62
AP
Labeling
STANDARD
2003-03-10 00:00:00
SUPPL
47
AP
2009-03-10 00:00:00
SUPPL
49
AP
2011-04-13 00:00:00
SUPPL
50
AP
2003-06-08 00:00:00
SUPPL
48
AP
2011-11-02 00:00:00
SUPPL
51
AP
2009-03-17 00:00:00
SUPPL
49
AP
2011-04-11 00:00:00
SUPPL
50
AP
2011-10-31 00:00:00
SUPPL
51
AP
2016-12-19 00:00:00
SUPPL
54
AP
2016-12-21 00:00:00
SUPPL
54
AP
2017-08-17 00:00:00
SUPPL
55
AP
2017-08-29 00:00:00
SUPPL
55
AP
2018-09-28 00:00:00
SUPPL
56
AP
2018-09-28 00:00:00
SUPPL
57
AP
2018-10-05 00:00:00
SUPPL
56
AP
2018-10-05 00:00:00
SUPPL
57
AP
2019-10-08 00:00:00
SUPPL
58
AP
2019-10-08 00:00:00
SUPPL
58
AP
2021-03-05 00:00:00
SUPPL
59
AP
2021-03-05 00:00:00
SUPPL
59
AP
2023-11-03 00:00:00
ORIG
1
AP
2023-12-18 00:00:00
SUPPL
60
AP
2024-11-04 00:00:00
SUPPL
61
AP
2025-12-29 00:00:00
SUPPL
62
AP
2026-01-06 00:00:00
SUPPL
62
AP
2026-01-06 00:00:00
SUPPL
62
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