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PREMARIN--
企业名称
申请类型
NDA--新药申请
 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
PREMARIN
AB
001
NDA
ESTROGENS, CONJUGATED
TABLET;ORAL
1.25MG
1
1
PREMARIN
002
NDA
ESTROGENS, CONJUGATED
TABLET;ORAL
2.5MG
0
0
PREMARIN
AB
003
NDA
ESTROGENS, CONJUGATED
TABLET;ORAL
0.3MG
1
0
PREMARIN
AB
004
NDA
ESTROGENS, CONJUGATED
TABLET;ORAL
0.625MG
1
1
PREMARIN
AB
005
NDA
ESTROGENS, CONJUGATED
TABLET;ORAL
0.9MG
1
1
PREMARIN
AB
006
NDA
ESTROGENS, CONJUGATED
TABLET;ORAL
0.45MG
1
0
 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
1942/5/8 0:00:00
ORIG
1
AP
Type 1 - New Molecular Entity
STANDARD
1984/1/26 0:00:00
SUPPL
49
AP
Manufacturing (CMC)
STANDARD
1985/4/29 0:00:00
SUPPL
51
AP
Labeling
1985/4/29 0:00:00
SUPPL
53
AP
Labeling
1985/4/29 0:00:00
SUPPL
54
AP
Labeling
1985/5/29 0:00:00
SUPPL
52
AP
Manufacturing (CMC)
STANDARD
1985/5/29 0:00:00
SUPPL
50
AP
Manufacturing (CMC)
STANDARD
1985/9/30 0:00:00
SUPPL
58
AP
Manufacturing (CMC)
STANDARD
1985/10/25 0:00:00
SUPPL
59
AP
Manufacturing (CMC)
STANDARD
1986/1/7 0:00:00
SUPPL
60
AP
Manufacturing (CMC)
STANDARD
1986/5/12 0:00:00
SUPPL
62
AP
Manufacturing (CMC)
STANDARD
1986/5/28 0:00:00
SUPPL
57
AP
Labeling
1986/7/10 0:00:00
SUPPL
63
AP
Manufacturing (CMC)
STANDARD
1986/9/24 0:00:00
SUPPL
66
AP
Manufacturing (CMC)
STANDARD
1986/12/3 0:00:00
SUPPL
65
AP
Manufacturing (CMC)
STANDARD
1987/5/14 0:00:00
SUPPL
70
AP
Manufacturing (CMC)
STANDARD
1987/10/16 0:00:00
SUPPL
68
AP
Manufacturing (CMC)
STANDARD
1988/4/17 0:00:00
SUPPL
71
AP
Manufacturing (CMC)
STANDARD
1988/12/20 0:00:00
SUPPL
73
AP
Manufacturing (CMC)
STANDARD
1989/2/3 0:00:00
SUPPL
74
AP
Manufacturing (CMC)
STANDARD
1989/5/19 0:00:00
SUPPL
75
AP
Labeling
1989/5/19 0:00:00
SUPPL
79
AP
Labeling
1989/5/19 0:00:00
SUPPL
72
AP
Labeling
1989/5/19 0:00:00
SUPPL
64
AP
Labeling
1989/5/19 0:00:00
SUPPL
61
AP
Labeling
1989/12/22 0:00:00
SUPPL
81
AP
Labeling
1990/2/23 0:00:00
SUPPL
83
AP
Manufacturing (CMC)
STANDARD
1991/5/9 0:00:00
SUPPL
78
AP
Manufacturing (CMC)
STANDARD
1991/5/14 0:00:00
SUPPL
77
AP
Manufacturing (CMC)
STANDARD
1992/3/11 0:00:00
SUPPL
87
AP
Manufacturing (CMC)
STANDARD
1993/12/23 0:00:00
SUPPL
92
AP
Labeling
STANDARD
1994/11/9 0:00:00
SUPPL
94
AP
Manufacturing (CMC)
STANDARD
1995/2/6 0:00:00
SUPPL
95
AP
Manufacturing (CMC)
STANDARD
1995/4/11 0:00:00
SUPPL
98
AP
Manufacturing (CMC)
STANDARD
1995/12/13 0:00:00
SUPPL
99
AP
Manufacturing (CMC)
STANDARD
1995/12/14 0:00:00
SUPPL
100
AP
Manufacturing (CMC)
STANDARD
1996/6/27 0:00:00
SUPPL
102
AP
Manufacturing (CMC)
STANDARD
1996/6/28 0:00:00
SUPPL
103
AP
Manufacturing (CMC)
STANDARD
1998/2/27 0:00:00
SUPPL
101
AP
Manufacturing (CMC)
STANDARD
1998/5/6 0:00:00
SUPPL
104
AP
Labeling
STANDARD
1998/5/6 0:00:00
SUPPL
96
AP
Labeling
STANDARD
1998/9/8 0:00:00
SUPPL
93
AP
Efficacy
UNKNOWN
1998/10/29 0:00:00
SUPPL
108
AP
Manufacturing (CMC)
STANDARD
1999/4/26 0:00:00
SUPPL
86
AP
Manufacturing (CMC)
STANDARD
1999/6/8 0:00:00
SUPPL
109
AP
Labeling
STANDARD
2000/7/5 0:00:00
SUPPL
113
AP
Manufacturing (CMC)
STANDARD
2001/4/24 0:00:00
SUPPL
116
AP
Manufacturing (CMC)
STANDARD
2001/8/6 0:00:00
SUPPL
120
AP
Manufacturing (CMC)
STANDARD
2001/12/3 0:00:00
SUPPL
121
AP
Manufacturing (CMC)
STANDARD
2002/8/21 0:00:00
SUPPL
124
AP
Manufacturing (CMC)
STANDARD
2002/11/27 0:00:00
SUPPL
128
AP
Labeling
STANDARD
2002/12/20 0:00:00
SUPPL
126
AP
Manufacturing (CMC)
STANDARD
2003/1/7 0:00:00
SUPPL
129
AP
Labeling
STANDARD
2003/4/24 0:00:00
SUPPL
130
AP
Labeling
STANDARD
2003/4/24 0:00:00
SUPPL
115
AP
Efficacy
STANDARD
2003/7/16 0:00:00
SUPPL
125
AP
Labeling
STANDARD
2004/4/20 0:00:00
SUPPL
133
AP
Labeling
STANDARD
2004/4/20 0:00:00
SUPPL
136
AP
Labeling
STANDARD
2004/8/26 0:00:00
SUPPL
137
AP
Manufacturing (CMC)
STANDARD
2005/4/7 0:00:00
SUPPL
138
AP
Labeling
STANDARD
2005/4/7 0:00:00
SUPPL
139
AP
Labeling
STANDARD
2005/8/1 0:00:00
SUPPL
141
AP
Manufacturing (CMC)
STANDARD
2005/11/1 0:00:00
SUPPL
142
AP
Manufacturing (CMC)
STANDARD
2006/4/24 0:00:00
SUPPL
146
AP
Labeling
STANDARD
2006/9/5 0:00:00
SUPPL
147
AP
Labeling
STANDARD
2008/3/3 0:00:00
SUPPL
155
AP
Labeling
STANDARD
2011/10/28 0:00:00
SUPPL
162
AP
Labeling
UNKNOWN
2011/10/28 0:00:00
SUPPL
164
AP
Labeling
UNKNOWN
2011/10/28 0:00:00
SUPPL
167
AP
Labeling
UNKNOWN
2014/4/11 0:00:00
SUPPL
163
AP
Manufacturing (CMC)
STANDARD
2014/12/3 0:00:00
SUPPL
171
AP
Labeling
STANDARD
2015/6/9 0:00:00
SUPPL
172
AP
Manufacturing (CMC)
STANDARD
2015/9/1 0:00:00
SUPPL
173
AP
Manufacturing (CMC)
STANDARD
2017/11/7 0:00:00
SUPPL
176
AP
Labeling
STANDARD
2024/2/15 0:00:00
SUPPL
181
AP
Labeling
STANDARD
2025/4/22 0:00:00
SUPPL
179
AP
Labeling
STANDARD
2003-07-28 00:00:00
SUPPL
125
AP
Letter
2002-11-27 00:00:00
SUPPL
128
AP
Letter
2003-05-16 00:00:00
SUPPL
130
AP
Letter
2005-04-12 00:00:00
SUPPL
138
AP
Letter
2005-08-04 00:00:00
SUPPL
141
AP
Letter
2005-11-03 00:00:00
SUPPL
142
AP
Letter
2006-09-18 00:00:00
SUPPL
147
AP
Letter
2011-10-31 00:00:00
SUPPL
164
AP
Letter
2011-10-31 00:00:00
SUPPL
167
AP
Letter
2014-12-04 00:00:00
SUPPL
171
AP
Letter
1998-09-08 00:00:00
SUPPL
93
AP
Letter
2003-05-16 00:00:00
SUPPL
115
AP
Letter
2003-01-07 00:00:00
SUPPL
129
AP
Letter
2004-04-29 00:00:00
SUPPL
133
AP
Letter
2004-04-29 00:00:00
SUPPL
136
AP
Letter
2004-08-31 00:00:00
SUPPL
137
AP
Letter
2005-04-12 00:00:00
SUPPL
139
AP
Letter
2006-04-25 00:00:00
SUPPL
146
AP
Letter
2008-03-05 00:00:00
SUPPL
155
AP
Letter
2011-10-31 00:00:00
SUPPL
162
AP
Letter
2003-04-28 00:00:00
SUPPL
115
AP
Label
2002-11-27 00:00:00
SUPPL
128
AP
Label
2003-01-07 00:00:00
SUPPL
129
AP
Label
2004-05-04 00:00:00
SUPPL
133
AP
Label
2004-11-17 00:00:00
SUPPL
136
AP
Label
2004-08-31 00:00:00
SUPPL
137
AP
Label
2005-04-12 00:00:00
SUPPL
139
AP
Label
2005-11-03 00:00:00
SUPPL
142
AP
Label
2011-11-01 00:00:00
SUPPL
164
AP
Label
2007-04-09 00:00:00
SUPPL
130
AP
Review
2003-04-30 00:00:00
SUPPL
130
AP
Label
2005-04-12 00:00:00
SUPPL
138
AP
Label
2005-08-04 00:00:00
SUPPL
141
AP
Label
2006-04-25 00:00:00
SUPPL
146
AP
Label
2006-09-12 00:00:00
SUPPL
147
AP
Label
2008-03-05 00:00:00
SUPPL
155
AP
Label
2011-11-01 00:00:00
SUPPL
162
AP
Label
2011-11-01 00:00:00
SUPPL
167
AP
Label
2014-12-10 00:00:00
SUPPL
171
AP
Label
1998-09-08 00:00:00
SUPPL
93
AP
Review
2007-04-09 00:00:00
SUPPL
115
AP
Review
2009-06-02 00:00:00
ORIG
1
AP
Other Important Information from FDA
2017-11-09 00:00:00
SUPPL
176
AP
Letter
2020-07-13 00:00:00
SUPPL
176
AP
Label
2024-02-16 00:00:00
SUPPL
181
AP
Letter
2024-02-20 00:00:00
SUPPL
181
AP
Label
2025-04-25 00:00:00
SUPPL
179
AP
Label
2025-05-01 00:00:00
SUPPL
179
AP
Letter
 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
 与本品相关的市场独占权保护信息
类型
产品号
独占权代码
 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
004782
PREMARIN
AB
006
NDA
ESTROGENS, CONJUGATED
TABLET;ORAL
0.45MG
1
0
214025
CONJUGATED ESTROGENS
AB
002
ANDA
ESTROGENS, CONJUGATED
TABLET;ORAL
0.45MG
0
0
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