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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
1972/3/22 0:00:00
ORIG
1
AP
Type 5 - New Formulation or New Manufacturer
STANDARD
1975/3/24 0:00:00
SUPPL
38
AP
Labeling
1975/4/23 0:00:00
SUPPL
39
AP
Manufacturing (CMC)
STANDARD
1975/9/4 0:00:00
SUPPL
42
AP
Labeling
1975/9/4 0:00:00
SUPPL
43
AP
Labeling
1975/9/4 0:00:00
SUPPL
44
AP
Labeling
1975/9/4 0:00:00
SUPPL
45
AP
Labeling
1975/9/4 0:00:00
SUPPL
46
AP
Labeling
1975/9/4 0:00:00
SUPPL
47
AP
Labeling
1976/1/9 0:00:00
SUPPL
48
AP
Manufacturing (CMC)
STANDARD
1976/5/28 0:00:00
SUPPL
55
AP
Manufacturing (CMC)
STANDARD
1976/6/25 0:00:00
SUPPL
54
AP
Labeling
1976/9/3 0:00:00
SUPPL
51
AP
Labeling
1976/9/3 0:00:00
SUPPL
52
AP
Labeling
1976/9/8 0:00:00
SUPPL
57
AP
Manufacturing (CMC)
STANDARD
1976/9/8 0:00:00
SUPPL
58
AP
Manufacturing (CMC)
STANDARD
1976/9/8 0:00:00
SUPPL
59
AP
Manufacturing (CMC)
STANDARD
1976/9/8 0:00:00
SUPPL
63
AP
Manufacturing (CMC)
STANDARD
1976/10/19 0:00:00
SUPPL
65
AP
Labeling
1976/10/19 0:00:00
SUPPL
66
AP
Labeling
1977/2/17 0:00:00
SUPPL
67
AP
Manufacturing (CMC)
STANDARD
1977/4/26 0:00:00
SUPPL
70
AP
Manufacturing (CMC)
STANDARD
1977/5/26 0:00:00
SUPPL
71
AP
Manufacturing (CMC)
STANDARD
1977/5/26 0:00:00
SUPPL
69
AP
Manufacturing (CMC)
STANDARD
1977/8/2 0:00:00
SUPPL
72
AP
Labeling
1977/12/14 0:00:00
SUPPL
74
AP
Manufacturing (CMC)
STANDARD
1977/12/14 0:00:00
SUPPL
75
AP
Labeling
1977/12/14 0:00:00
SUPPL
81
AP
Labeling
1977/12/14 0:00:00
SUPPL
80
AP
Manufacturing (CMC)
STANDARD
1977/12/14 0:00:00
SUPPL
79
AP
Labeling
1978/1/3 0:00:00
SUPPL
73
AP
Manufacturing (CMC)
STANDARD
1978/4/27 0:00:00
SUPPL
77
AP
Labeling
1978/4/27 0:00:00
SUPPL
78
AP
Manufacturing (CMC)
STANDARD
1978/7/31 0:00:00
SUPPL
83
AP
Manufacturing (CMC)
STANDARD
1978/7/31 0:00:00
SUPPL
82
AP
Labeling
1978/7/31 0:00:00
SUPPL
85
AP
Labeling
1978/8/4 0:00:00
SUPPL
84
AP
Manufacturing (CMC)
STANDARD
1978/8/4 0:00:00
SUPPL
86
AP
Manufacturing (CMC)
STANDARD
1978/10/4 0:00:00
SUPPL
87
AP
Labeling
1979/1/16 0:00:00
SUPPL
90
AP
Manufacturing (CMC)
STANDARD
1979/1/16 0:00:00
SUPPL
89
AP
Manufacturing (CMC)
STANDARD
1979/1/16 0:00:00
SUPPL
88
AP
Labeling
1979/3/6 0:00:00
SUPPL
91
AP
Manufacturing (CMC)
STANDARD
1979/9/25 0:00:00
SUPPL
92
AP
Manufacturing (CMC)
STANDARD
1980/1/21 0:00:00
SUPPL
93
AP
Manufacturing (CMC)
STANDARD
1981/5/22 0:00:00
SUPPL
94
AP
Labeling
1981/11/20 0:00:00
SUPPL
95
AP
Labeling
1982/6/4 0:00:00
SUPPL
96
AP
Manufacturing (CMC)
STANDARD
1982/8/18 0:00:00
SUPPL
97
AP
Manufacturing (CMC)
STANDARD
1982/10/6 0:00:00
SUPPL
98
AP
Manufacturing (CMC)
STANDARD
1983/6/10 0:00:00
SUPPL
100
AP
Manufacturing (CMC)
STANDARD
1983/9/5 0:00:00
SUPPL
101
AP
Labeling
1983/9/13 0:00:00
SUPPL
99
AP
Manufacturing (CMC)
STANDARD
1983/12/21 0:00:00
SUPPL
102
AP
Labeling
1984/3/5 0:00:00
SUPPL
13
AP
Labeling
1984/8/2 0:00:00
SUPPL
104
AP
Manufacturing (CMC)
STANDARD
1984/10/11 0:00:00
SUPPL
107
AP
Labeling
1984/10/11 0:00:00
SUPPL
105
AP
Labeling
1985/5/13 0:00:00
SUPPL
109
AP
Labeling
1985/8/29 0:00:00
SUPPL
111
AP
Manufacturing (CMC)
STANDARD
1985/8/29 0:00:00
SUPPL
110
AP
Manufacturing (CMC)
STANDARD
1985/10/10 0:00:00
SUPPL
113
AP
Manufacturing (CMC)
STANDARD
1986/1/21 0:00:00
SUPPL
108
AP
Manufacturing (CMC)
STANDARD
1986/1/30 0:00:00
SUPPL
114
AP
Labeling
1986/4/7 0:00:00
SUPPL
112
AP
Manufacturing (CMC)
STANDARD
1986/9/23 0:00:00
SUPPL
116
AP
Manufacturing (CMC)
STANDARD
1987/3/10 0:00:00
SUPPL
118
AP
Manufacturing (CMC)
STANDARD
1987/4/24 0:00:00
SUPPL
119
AP
Manufacturing (CMC)
STANDARD
1987/4/29 0:00:00
SUPPL
115
AP
Labeling
1987/4/29 0:00:00
SUPPL
117
AP
Manufacturing (CMC)
STANDARD
1987/7/2 0:00:00
SUPPL
121
AP
Labeling
1987/7/2 0:00:00
SUPPL
120
AP
Labeling
1987/9/16 0:00:00
SUPPL
122
AP
Labeling
1987/10/14 0:00:00
SUPPL
123
AP
Labeling
1989/6/20 0:00:00
SUPPL
126
AP
Labeling
1989/6/20 0:00:00
SUPPL
125
AP
Labeling
1989/6/28 0:00:00
SUPPL
124
AP
Labeling
1989/9/27 0:00:00
SUPPL
127
AP
Manufacturing (CMC)
STANDARD
1991/4/23 0:00:00
SUPPL
128
AP
Labeling
1993/2/9 0:00:00
SUPPL
130
AP
Manufacturing (CMC)
STANDARD
1996/3/5 0:00:00
SUPPL
131
AP
Manufacturing (CMC)
STANDARD
1997/4/24 0:00:00
SUPPL
132
AP
Manufacturing (CMC)
STANDARD
1998/2/20 0:00:00
SUPPL
134
AP
Manufacturing (CMC)
STANDARD
1998/6/23 0:00:00
SUPPL
133
AP
Labeling
STANDARD
1999/5/13 0:00:00
SUPPL
138
AP
Manufacturing (CMC)
STANDARD
1999/9/30 0:00:00
SUPPL
136
AP
Labeling
STANDARD
2000/2/15 0:00:00
SUPPL
139
AP
Manufacturing (CMC)
STANDARD
2000/5/1 0:00:00
SUPPL
140
AP
Manufacturing (CMC)
STANDARD
2000/5/26 0:00:00
SUPPL
141
AP
Manufacturing (CMC)
STANDARD
2000/5/26 0:00:00
SUPPL
142
AP
Manufacturing (CMC)
STANDARD
2000/5/31 0:00:00
SUPPL
143
AP
Manufacturing (CMC)
STANDARD
2000/11/16 0:00:00
SUPPL
144
AP
Manufacturing (CMC)
STANDARD
2001/8/31 0:00:00
SUPPL
145
AP
Manufacturing (CMC)
STANDARD
2002/2/5 0:00:00
SUPPL
146
AP
Labeling
STANDARD
2002/7/15 0:00:00
SUPPL
147
AP
Manufacturing (CMC)
STANDARD
2002/11/21 0:00:00
SUPPL
149
AP
Manufacturing (CMC)
STANDARD
2002/11/22 0:00:00
SUPPL
151
AP
Manufacturing (CMC)
STANDARD
2002/11/22 0:00:00
SUPPL
148
AP
Manufacturing (CMC)
STANDARD
2002/11/25 0:00:00
SUPPL
150
AP
Manufacturing (CMC)
STANDARD
2005/9/2 0:00:00
SUPPL
154
AP
Manufacturing (CMC)
STANDARD
2005-09-07 00:00:00
SUPPL
156
AP
2008-01-09 00:00:00
SUPPL
161
AP
2009-02-19 00:00:00
SUPPL
162
AP
2005-09-07 00:00:00
SUPPL
154
AP
2006-10-05 00:00:00
SUPPL
158
AP
2009-10-16 00:00:00
SUPPL
165
AP
2011-03-04 00:00:00
SUPPL
168
AP
2012-01-26 00:00:00
SUPPL
169
AP
2005-09-07 00:00:00
SUPPL
154
AP
2005-09-07 00:00:00
SUPPL
155
AP
2006-10-13 00:00:00
SUPPL
158
AP
2009-11-09 00:00:00
SUPPL
165
AP
2011-02-28 00:00:00
SUPPL
168
AP
2011-12-29 00:00:00
SUPPL
169
AP
2005-09-07 00:00:00
SUPPL
155
AP
2005-09-07 00:00:00
SUPPL
156
AP
2007-12-21 00:00:00
SUPPL
161
AP
2017-05-10 00:00:00
SUPPL
178
AP
2017-05-12 00:00:00
SUPPL
178
AP
2019-07-26 00:00:00
SUPPL
183
AP
2020-04-06 00:00:00
SUPPL
187
AP
2020-04-06 00:00:00
SUPPL
187
AP
2024-10-25 00:00:00
SUPPL
201
AP
2024-10-28 00:00:00
SUPPL
201
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