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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
1974/11/22 0:00:00
ORIG
1
AP
Type 5 - New Formulation or New Manufacturer
STANDARD
1975/12/12 0:00:00
SUPPL
2
AP
Manufacturing (CMC)
STANDARD
1976/2/24 0:00:00
SUPPL
12
AP
Manufacturing (CMC)
STANDARD
1976/3/18 0:00:00
SUPPL
13
AP
Manufacturing (CMC)
STANDARD
1976/4/16 0:00:00
SUPPL
14
AP
Manufacturing (CMC)
STANDARD
1977/2/24 0:00:00
SUPPL
15
AP
Manufacturing (CMC)
STANDARD
1977/2/24 0:00:00
SUPPL
16
AP
Labeling
1977/2/24 0:00:00
SUPPL
19
AP
Manufacturing (CMC)
STANDARD
1977/6/29 0:00:00
SUPPL
21
AP
REMS
STANDARD
1977/6/29 0:00:00
SUPPL
22
AP
Manufacturing (CMC)
STANDARD
1977/9/13 0:00:00
SUPPL
23
AP
Manufacturing (CMC)
STANDARD
1978/4/14 0:00:00
SUPPL
24
AP
Manufacturing (CMC)
STANDARD
1978/6/2 0:00:00
SUPPL
25
AP
Labeling
1978/6/2 0:00:00
SUPPL
26
AP
Labeling
1978/7/7 0:00:00
SUPPL
27
AP
Manufacturing (CMC)
STANDARD
1978/7/7 0:00:00
SUPPL
28
AP
Labeling
1978/7/7 0:00:00
SUPPL
29
AP
Manufacturing (CMC)
STANDARD
1981/3/2 0:00:00
SUPPL
30
AP
Labeling
1981/5/26 0:00:00
SUPPL
31
AP
Manufacturing (CMC)
STANDARD
1985/10/4 0:00:00
SUPPL
32
AP
Labeling
1986/1/14 0:00:00
SUPPL
33
AP
Manufacturing (CMC)
STANDARD
1986/4/7 0:00:00
SUPPL
34
AP
Manufacturing (CMC)
STANDARD
1986/12/19 0:00:00
SUPPL
35
AP
Labeling
1987/5/22 0:00:00
SUPPL
36
AP
Manufacturing (CMC)
STANDARD
1987/9/14 0:00:00
SUPPL
37
AP
Labeling
1987/11/19 0:00:00
SUPPL
38
AP
Labeling
1989/4/28 0:00:00
SUPPL
42
AP
Labeling
1989/6/14 0:00:00
SUPPL
41
AP
Manufacturing (CMC)
STANDARD
1989/6/14 0:00:00
SUPPL
40
AP
Manufacturing (CMC)
STANDARD
1989/6/14 0:00:00
SUPPL
39
AP
Manufacturing (CMC)
STANDARD
1989/6/14 0:00:00
SUPPL
44
AP
Manufacturing (CMC)
STANDARD
1989/6/14 0:00:00
SUPPL
43
AP
Manufacturing (CMC)
STANDARD
1990/1/17 0:00:00
SUPPL
45
AP
Labeling
1990/2/16 0:00:00
SUPPL
46
AP
Manufacturing (CMC)
STANDARD
1991/4/3 0:00:00
SUPPL
47
AP
Manufacturing (CMC)
STANDARD
1991/4/23 0:00:00
SUPPL
49
AP
Labeling
1991/7/10 0:00:00
SUPPL
50
AP
Labeling
1991/10/18 0:00:00
SUPPL
48
AP
Manufacturing (CMC)
STANDARD
1992/7/28 0:00:00
SUPPL
53
AP
Manufacturing (CMC)
STANDARD
1992/7/28 0:00:00
SUPPL
52
AP
Manufacturing (CMC)
STANDARD
1993/8/11 0:00:00
SUPPL
51
AP
Manufacturing (CMC)
STANDARD
1993/11/8 0:00:00
SUPPL
54
AP
Manufacturing (CMC)
STANDARD
1994/6/29 0:00:00
SUPPL
55
AP
Manufacturing (CMC)
STANDARD
1996/11/25 0:00:00
SUPPL
56
AP
Manufacturing (CMC)
STANDARD
1998/5/1 0:00:00
SUPPL
57
AP
Manufacturing (CMC)
STANDARD
1999/1/27 0:00:00
SUPPL
58
AP
Manufacturing (CMC)
STANDARD
2024/10/24 0:00:00
SUPPL
60
AP
Labeling
STANDARD
2024-10-25 00:00:00
SUPPL
60
AP
2024-10-28 00:00:00
SUPPL
60
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