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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
1972/2/22 0:00:00
ORIG
1
AP
Type 5 - New Formulation or New Manufacturer
STANDARD
1975/8/29 0:00:00
SUPPL
7
AP
Manufacturing (CMC)
STANDARD
1976/1/9 0:00:00
SUPPL
10
AP
Manufacturing (CMC)
STANDARD
1976/1/9 0:00:00
SUPPL
11
AP
Manufacturing (CMC)
STANDARD
1976/2/9 0:00:00
SUPPL
12
AP
Labeling
1976/2/9 0:00:00
SUPPL
8
AP
Manufacturing (CMC)
STANDARD
1976/3/17 0:00:00
SUPPL
9
AP
Manufacturing (CMC)
STANDARD
1976/6/16 0:00:00
SUPPL
14
AP
Manufacturing (CMC)
STANDARD
1976/12/3 0:00:00
SUPPL
17
AP
Manufacturing (CMC)
STANDARD
1976/12/3 0:00:00
SUPPL
19
AP
Manufacturing (CMC)
STANDARD
1977/1/26 0:00:00
SUPPL
16
AP
Manufacturing (CMC)
STANDARD
1977/12/4 0:00:00
SUPPL
15
AP
Labeling
1977/12/14 0:00:00
SUPPL
20
AP
Manufacturing (CMC)
STANDARD
1978/5/23 0:00:00
SUPPL
21
AP
Labeling
1978/11/21 0:00:00
SUPPL
22
AP
Manufacturing (CMC)
STANDARD
1978/11/21 0:00:00
SUPPL
23
AP
Manufacturing (CMC)
STANDARD
1979/10/31 0:00:00
SUPPL
24
AP
Manufacturing (CMC)
STANDARD
1979/10/31 0:00:00
SUPPL
25
AP
Manufacturing (CMC)
STANDARD
1981/2/24 0:00:00
SUPPL
27
AP
Labeling
1981/3/24 0:00:00
SUPPL
26
AP
Manufacturing (CMC)
STANDARD
1982/5/6 0:00:00
SUPPL
30
AP
Labeling
1982/9/17 0:00:00
SUPPL
29
AP
Manufacturing (CMC)
STANDARD
1982/9/21 0:00:00
SUPPL
31
AP
Manufacturing (CMC)
STANDARD
1982/9/21 0:00:00
SUPPL
32
AP
Manufacturing (CMC)
STANDARD
1983/1/4 0:00:00
SUPPL
33
AP
Manufacturing (CMC)
STANDARD
1983/11/2 0:00:00
SUPPL
34
AP
Manufacturing (CMC)
STANDARD
1983/11/2 0:00:00
SUPPL
36
AP
Manufacturing (CMC)
STANDARD
1983/11/2 0:00:00
SUPPL
38
AP
Manufacturing (CMC)
STANDARD
1983/11/2 0:00:00
SUPPL
39
AP
Manufacturing (CMC)
STANDARD
1983/11/2 0:00:00
SUPPL
40
AP
Manufacturing (CMC)
STANDARD
1983/11/2 0:00:00
SUPPL
41
AP
Manufacturing (CMC)
STANDARD
1984/11/6 0:00:00
SUPPL
48
AP
Manufacturing (CMC)
STANDARD
1985/5/16 0:00:00
SUPPL
37
AP
Manufacturing (CMC)
STANDARD
1985/7/29 0:00:00
SUPPL
49
AP
Efficacy
1985/12/5 0:00:00
SUPPL
42
AP
Manufacturing (CMC)
STANDARD
1985/12/5 0:00:00
SUPPL
43
AP
Manufacturing (CMC)
STANDARD
1985/12/5 0:00:00
SUPPL
44
AP
Manufacturing (CMC)
STANDARD
1985/12/5 0:00:00
SUPPL
45
AP
Manufacturing (CMC)
STANDARD
1985/12/5 0:00:00
SUPPL
46
AP
Manufacturing (CMC)
STANDARD
1985/12/5 0:00:00
SUPPL
47
AP
Manufacturing (CMC)
STANDARD
1986/4/7 0:00:00
SUPPL
53
AP
Labeling
1986/4/28 0:00:00
SUPPL
54
AP
Manufacturing (CMC)
STANDARD
1987/9/22 0:00:00
SUPPL
50
AP
Manufacturing (CMC)
STANDARD
1987/9/22 0:00:00
SUPPL
51
AP
Manufacturing (CMC)
STANDARD
1988/2/16 0:00:00
SUPPL
58
AP
Manufacturing (CMC)
STANDARD
1988/9/22 0:00:00
SUPPL
60
AP
Labeling
1989/6/8 0:00:00
SUPPL
61
AP
Manufacturing (CMC)
STANDARD
1989/12/1 0:00:00
SUPPL
57
AP
Manufacturing (CMC)
STANDARD
1992/6/26 0:00:00
SUPPL
56
AP
Labeling
1993/8/25 0:00:00
SUPPL
69
AP
Labeling
1994/10/27 0:00:00
SUPPL
78
AP
Manufacturing (CMC)
STANDARD
1995/5/17 0:00:00
SUPPL
84
AP
Manufacturing (CMC)
STANDARD
1996/7/26 0:00:00
SUPPL
73
AP
Manufacturing (CMC)
STANDARD
1997/6/24 0:00:00
SUPPL
95
AP
Manufacturing (CMC)
STANDARD
1997/11/4 0:00:00
SUPPL
96
AP
Manufacturing (CMC)
STANDARD
1998/8/6 0:00:00
SUPPL
94
AP
Manufacturing (CMC)
STANDARD
1998/8/6 0:00:00
SUPPL
62
AP
Manufacturing (CMC)
STANDARD
1998/8/6 0:00:00
SUPPL
63
AP
Manufacturing (CMC)
STANDARD
1999/12/13 0:00:00
SUPPL
98
AP
Manufacturing (CMC)
STANDARD
2000/3/8 0:00:00
SUPPL
97
AP
Manufacturing (CMC)
STANDARD
2002/3/22 0:00:00
SUPPL
99
AP
Labeling
STANDARD
2008/9/23 0:00:00
SUPPL
108
AP
Labeling
STANDARD
2010/6/11 0:00:00
SUPPL
120
AP
Labeling
UNKNOWN
2011/3/31 0:00:00
SUPPL
115
AP
Manufacturing (CMC)
N/A
2011/6/24 0:00:00
SUPPL
128
AP
Labeling
UNKNOWN
2011/12/23 0:00:00
SUPPL
131
AP
Labeling
UNKNOWN
2013/9/24 0:00:00
SUPPL
136
AP
Manufacturing (CMC)
STANDARD
2014/3/21 0:00:00
SUPPL
135
AP
Labeling
UNKNOWN
2015/3/9 0:00:00
SUPPL
134
AP
Manufacturing (CMC)
STANDARD
2015/7/21 0:00:00
SUPPL
137
AP
Manufacturing (CMC)
STANDARD
2015/12/23 0:00:00
SUPPL
129
AP
Manufacturing (CMC)
STANDARD
2016/6/9 0:00:00
SUPPL
139
AP
Manufacturing (CMC)
STANDARD
2017/8/24 0:00:00
SUPPL
140
AP
Labeling
STANDARD
2018/11/16 0:00:00
SUPPL
141
AP
Labeling
STANDARD
2020/7/2 0:00:00
SUPPL
156
AP
Labeling
STANDARD
2021/6/7 0:00:00
SUPPL
159
AP
Labeling
STANDARD
2024/10/24 0:00:00
SUPPL
178
AP
Labeling
STANDARD
2002-03-22 00:00:00
SUPPL
99
AP
2008-09-26 00:00:00
SUPPL
108
AP
2010-06-14 00:00:00
SUPPL
120
AP
2010-06-24 00:00:00
SUPPL
120
AP
2011-07-05 00:00:00
SUPPL
128
AP
2011-12-29 00:00:00
SUPPL
131
AP
2014-04-07 00:00:00
SUPPL
135
AP
2008-10-03 00:00:00
SUPPL
108
AP
2011-12-23 00:00:00
SUPPL
131
AP
2017-08-28 00:00:00
SUPPL
140
AP
2017-08-28 00:00:00
SUPPL
140
AP
2018-11-20 00:00:00
SUPPL
141
AP
2018-12-07 00:00:00
SUPPL
141
AP
2020-07-06 00:00:00
SUPPL
156
AP
2020-07-06 00:00:00
SUPPL
156
AP
2021-06-08 00:00:00
SUPPL
159
AP
2021-09-20 00:00:00
SUPPL
159
AP
2024-10-25 00:00:00
SUPPL
178
AP
2024-10-28 00:00:00
SUPPL
178
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