当前位置：药药网 / 药品 / 美国FDA药品数据库详细
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
2013/10/25 0:00:00
ORIG
1
AP
Type 3 - New Dosage Form
STANDARD
2014/8/19 0:00:00
SUPPL
2
AP
Labeling
STANDARD
2014/9/22 0:00:00
SUPPL
1
AP
Manufacturing (CMC)
STANDARD
2015/1/30 0:00:00
SUPPL
3
AP
Manufacturing (CMC)
N/A
2015/6/26 0:00:00
SUPPL
6
AP
REMS
N/A
2016/4/20 0:00:00
SUPPL
7
AP
REMS
N/A
2016/9/30 0:00:00
SUPPL
11
AP
REMS
N/A
2016/12/16 0:00:00
SUPPL
10
AP
Labeling
STANDARD
2016/12/16 0:00:00
SUPPL
9
AP
Labeling
STANDARD
2017/5/26 0:00:00
SUPPL
12
AP
REMS
N/A
2018/9/18 0:00:00
SUPPL
15
AP
Labeling
STANDARD
2018/9/18 0:00:00
SUPPL
14
AP
REMS
N/A
2019/10/7 0:00:00
SUPPL
19
AP
Labeling
STANDARD
2021/3/4 0:00:00
SUPPL
20
AP
Labeling
STANDARD
2013-10-25 00:00:00
ORIG
1
AP
2016-04-22 00:00:00
SUPPL
7
AP
2013-10-25 00:00:00
ORIG
1
AP
2014-08-20 00:00:00
SUPPL
2
AP
2014-04-01 00:00:00
ORIG
1
AP
2014-08-20 00:00:00
SUPPL
2
AP
2015-02-05 00:00:00
SUPPL
3
AP
2015-07-07 00:00:00
SUPPL
6
AP
2015-02-17 00:00:00
SUPPL
3
AP
2014-04-14 00:00:00
ORIG
1
AP
2013-11-15 00:00:00
ORIG
1
AP
2015-02-06 00:00:00
SUPPL
3
AP
2016-10-03 00:00:00
SUPPL
11
AP
2016-12-20 00:00:00
SUPPL
9
AP
2016-12-20 00:00:00
SUPPL
10
AP
2016-12-21 00:00:00
SUPPL
9
AP
2016-12-21 00:00:00
SUPPL
10
AP
2017-05-31 00:00:00
SUPPL
12
AP
2018-09-21 00:00:00
SUPPL
14
AP
2018-09-21 00:00:00
SUPPL
15
AP
2018-10-01 00:00:00
SUPPL
14
AP
2018-10-01 00:00:00
SUPPL
15
AP
2019-10-08 00:00:00
SUPPL
19
AP
2019-10-09 00:00:00
SUPPL
19
AP
2021-03-08 00:00:00
SUPPL
20
AP
2021-03-08 00:00:00
SUPPL
20
AP
2021-03-08 00:00:00
SUPPL
20
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
N
001
9333201
Jul 25, 2033
U-1810
N
001
9421200
Jul 25, 2033
U-1810
N
001
9610286
Jul 25, 2033
U-1810
N
001
9132096
Sep 12, 2034
Y
N
001
9421200
Jul 25, 2033
U-1810
N
001
9610286
Jul 25, 2033
U-1810
N
001
10722511
Jul 25, 2033
U-1810
N
001
10028946
Jul 25, 2033
U-1810
N
001
9433619
Jul 25, 2033
U-1810
N
001
9265760
Jul 25, 2033
U-1810
N
001
10456393
Jul 25, 2033
U-1810
N
001
10092559
Sep 12, 2034
U-55
N
001
9339499
Jul 25, 2033
U-1810
N
001
9486451
Sep 12, 2034
U-55
N
001
9452163
Sep 12, 2034
U-55
N
001
9713611
Sep 12, 2034
Y
U-55
N
001
9333201
Jul 25, 2033
U-1810
N
001
9326982
Jul 25, 2033
U-1810
N
001
9326982
Jul 25, 2033
U-1810
N
001
9713611
Sep 12, 2034
Y
U-55
N
001
9339499
Jul 25, 2033
U-1810
N
001
9486451
Sep 12, 2034
U-55
N
001
9452163
Sep 12, 2034
U-55
N
001
10092559
Sep 12, 2034
U-55
N
001
10456393
Jul 25, 2033
U-1810
N
001
10028946
Jul 25, 2033
U-1810
N
001
9265760
Jul 25, 2033
U-1810
N
001
9433619
Jul 25, 2033
U-1810
N
001
10722511
Jul 25, 2033
U-1810
N
001
9132096
Sep 12, 2034
Y
N
001
10322120
Jul 25, 2033
Y
N
001
10322120
Jul 25, 2033
Y
N
002
10322120
Jul 25, 2033
Y
N
002
10322120
Jul 25, 2033
Y
N
002
10722511
Jul 25, 2033
U-1810
N
002
9132096
Sep 12, 2034
Y
N
002
9265760
Jul 25, 2033
U-1810
N
002
10456393
Jul 25, 2033
U-1810
N
002
9610286
Jul 25, 2033
U-1810
N
002
9333201
Jul 25, 2033
U-1810
N
002
9486451
Sep 12, 2034
U-55
N
002
9452163
Sep 12, 2034
U-55
N
002
10028946
Jul 25, 2033
U-1810
N
002
9326982
Jul 25, 2033
U-1810
N
002
9713611
Sep 12, 2034
Y
U-55
N
002
10092559
Sep 12, 2034
U-55
N
002
9421200
Jul 25, 2033
U-1810
N
002
9433619
Jul 25, 2033
U-1810
N
002
9339499
Jul 25, 2033
U-1810
N
002
9339499
Jul 25, 2033
U-1810
N
002
9421200
Jul 25, 2033
U-1810
N
002
9433619
Jul 25, 2033
U-1810
N
002
9486451
Sep 12, 2034
U-55
N
002
9326982
Jul 25, 2033
U-1810
N
002
10028946
Jul 25, 2033
U-1810
N
002
10092559
Sep 12, 2034
U-55
N
002
9713611
Sep 12, 2034
Y
U-55
N
002
9452163
Sep 12, 2034
U-55
N
002
9333201
Jul 25, 2033
U-1810
N
002
9610286
Jul 25, 2033
U-1810
N
002
10456393
Jul 25, 2033
U-1810
N
002
9265760
Jul 25, 2033
U-1810
N
002
10722511
Jul 25, 2033
U-1810
N
002
9132096
Sep 12, 2034
Y
N
003
10322120
Jul 25, 2033
Y
N
003
9132096
Sep 12, 2034
Y
N
003
9265760
Jul 25, 2033
U-1810
N
003
10722511
Jul 25, 2033
U-1810
N
003
10456393
Jul 25, 2033
U-1810
N
003
9452163
Sep 12, 2034
U-55
N
003
9339499
Jul 25, 2033
U-1810
N
003
10028946
Jul 25, 2033
U-1810
N
003
10092559
Sep 12, 2034
U-55
N
003
9713611
Sep 12, 2034
Y
U-55
N
003
9433619
Jul 25, 2033
U-1810
N
003
9421200
Jul 25, 2033
U-1810
N
003
9610286
Jul 25, 2033
U-1810
N
003
9333201
Jul 25, 2033
U-1810
N
003
9326982
Jul 25, 2033
U-1810
N
003
9486451
Sep 12, 2034
U-55
N
003
9486451
Sep 12, 2034
U-55
N
003
9433619
Jul 25, 2033
U-1810
N
003
9421200
Jul 25, 2033
U-1810
N
003
9326982
Jul 25, 2033
U-1810
N
003
10092559
Sep 12, 2034
U-55
N
003
9610286
Jul 25, 2033
U-1810
N
003
9333201
Jul 25, 2033
U-1810
N
003
10028946
Jul 25, 2033
U-1810
N
003
9713611
Sep 12, 2034
Y
U-55
N
003
9452163
Sep 12, 2034
U-55
N
003
9339499
Jul 25, 2033
U-1810
N
003
10456393
Jul 25, 2033
U-1810
N
003
10722511
Jul 25, 2033
U-1810
N
003
9265760
Jul 25, 2033
U-1810
N
003
10322120
Jul 25, 2033
Y
N
003
9132096
Sep 12, 2034
Y
N
004
10722511
Jul 25, 2033
U-1810
N
004
9433619
Jul 25, 2033
U-1810
N
004
9713611
Sep 12, 2034
Y
U-55
N
004
10456393
Jul 25, 2033
U-1810
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