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当前位置:药药网 / 药品 / 美国FDA药品数据库(本栏目更新到2026-3-31)
药品名称:
商品名称:
药品NDC:
上市日期:
-
格式:2020-5-3
注册申请号:
市场分类:
不限
OTC MONOGRAPH NOT FINAL
UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE
ANDA
BLA
NDA AUTHORIZED GENERIC
NDA
UNAPPROVED MEDICAL GAS
OTC MONOGRAPH FINAL
UNAPPROVED HOMEOPATHIC
UNAPPROVED DRUG OTHER
活性成分:
持证企业:
美国药品NDC(国家药品编码)与药品说明书数据库
美国NDC未完成药物数据库文件
美国NDC复合药物数据库文件
美国NDC 数据库排除药物数据库文件
 美国药品NDC(国家药品编码)与药品说明书数据库31条(本栏目更新到2026-3-31)
药品名称(分析)
商品名
药品NDC
专利人(分析)
上市日期
活性成分
市场分类
规格(分析)
申请号
Levetiracetam in Sodium Chloride
Levetiracetam in Sodium Chloride
0143-9281
Hikma Pharmaceuticals USA Inc.
20250208
LEVETIRACETAM
ANDA
5
anda
21135
6
Levetiracetam in Sodium Chloride
Levetiracetam in Sodium Chloride
0143-9282
Hikma Pharmaceuticals USA Inc.
20250208
LEVETIRACETAM
ANDA
10
anda
21135
6
Levetiracetam in Sodium Chloride
Levetiracetam in Sodium Chloride
0143-9283
Hikma Pharmaceuticals USA Inc.
20250208
LEVETIRACETAM
ANDA
15
anda
21135
6
iron sucrose
Venofer
0517-2310
American Regent, Inc.
20070612
IRON SUCROSE
NDA
20
nda0
21135
iron sucrose
Venofer
0517-2325
American Regent, Inc.
20110127
IRON SUCROSE
NDA
20
nda0
21135
iron sucrose
Venofer
0517-2340
American Regent, Inc.
20140714
IRON SUCROSE
NDA
20
nda0
21135
iron sucrose
Venofer
0517-2340
American Regent, Inc.
20001110
IRON SUCROSE
NDA
20
nda0
21135
Norepinephrine Bitartrate
NOREPINEPHRINE BITARTRATE
0781-3755
Sandoz Inc
20190423
NOREPINEPHRINE BITARTRATE
ANDA
1
anda
21135
9
iron sucrose
Venofer
49230-530
Fresenius Medical Care Holdings, Inc.
20110127
IRON SUCROSE
NDA
20
nda0
21135
iron sucrose
Venofer
49230-534
Fresenius Medical Care Holdings, Inc.
20081104
IRON SUCROSE
NDA
20
nda0
21135
lumacaftor and ivacaftor
ORKAMBI
51167-122
Vertex Pharmaceuticals Incorporated
20220902
IVACAFTOR; LUMACAFTOR
NDA
94; 75
nda
21135
8
lumacaftor and ivacaftor
ORKAMBI
51167-500
Vertex Pharmaceuticals Incorporated
20180807
IVACAFTOR; LUMACAFTOR
NDA
188; 150
nda
21135
8
lumacaftor and ivacaftor
ORKAMBI
51167-900
Vertex Pharmaceuticals Incorporated
20180807
IVACAFTOR; LUMACAFTOR
NDA
125; 100
nda
21135
8
VENOFER (IRON SUCROSE)
VENOFER (IRON SUCROSE)
51662-1568
HF Acquisition Co LLC, DBA HealthFirst
20210625
IRON SUCROSE
NDA
20
nda0
21135
omega-3-acid ethyl esters
omega-3-acid ethyl esters
62135-780
Chartwell RX, LLC
20200219
OMEGA-3-ACID ETHYL ESTERS
ANDA
900
anda
21135
5
Amantadine Hydrochloride
Amantadine Hydrochloride
64380-862
Strides Pharma Science Limited
20221201
AMANTADINE HYDROCHLORIDE
ANDA
100
anda
21135
4
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate
Dextroamphetamine Saccharate, Amphetamine Aspartat
64850-500
Elite Laboratories, Inc.
20221229
AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
ANDA
1.25; 1.25; 1.25; 1.25
anda
21135
2
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate
Dextroamphetamine Saccharate, Amphetamine Aspartat
64850-501
Elite Laboratories, Inc.
20221229
AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
ANDA
1.875; 1.875; 1.875; 1.875
anda
21135
2
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate
Dextroamphetamine Saccharate, Amphetamine Aspartat
64850-502
Elite Laboratories, Inc.
20221229
AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
ANDA
2.5; 2.5; 2.5; 2.5
anda
21135
2
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate
Dextroamphetamine Saccharate, Amphetamine Aspartat
64850-503
Elite Laboratories, Inc.
20221229
AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
ANDA
3.125; 3.125; 3.125; 3.125
anda
21135
2
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