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当前位置:药药网 / 药品 / 美国FDA药品数据库(本栏目收费,不能显示细节,电话13136136841)
药品名称:
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药品NDC:
上市日期:
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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106241条(本栏目收费,不能显示细节,电话13136136841)
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
dextromethorphan polistirex
Robitussin 12 Hour Cough Relief
0031-8755
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
20160705
DEXTROMETHORPHAN HYDROBROMIDE
ANDA
30
ANDA091135
dextromethorphan HBr, guaifenesin
Robitussin Honey Maximum Strength Cough and Chest Congestion DM
0031-8756
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
20180625
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
OTC MONOGRAPH FINAL
part341
dextromethorphan hydrobromide and guaifenesin
ROBITUSSIN COUGH PLUS CHEST CONGESTION DM
0031-8757
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
20180601
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
OTC MONOGRAPH FINAL
part341
dextromethorphan HBr, doxylamine succinate
Robitussin Honey Maximum Strength Nighttime Cough DM
0031-8758
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
20180625
DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
OTC MONOGRAPH FINAL
part341
dextromethorphan hydrobromide, guaifenesin
Robitussin Sugar-Free Dye-Free Cough Plus Chest Congestion DM
0031-8759
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
20180216
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
OTC MONOGRAPH FINAL
part341
dextromethorphan HBr, guaifenesin
Childrens Robitussin Honey Cough and Chest Congestion DM
0031-8760
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
20180625
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
OTC MONOGRAPH FINAL
part341
dextromethorphan hbr, doxylamine succinate
Childrens Robitussin Honey Nighttime Cough DM
0031-8762
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
20190527
DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
OTC MONOGRAPH FINAL
part341
Dextromethorphan Hydrobromide, Guaifenesin
Robitussin Maximum Strength 12 Hour Cough and Mucus Relief
0031-8765
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
20190614
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
ANDA
ANDA207602
acetaminophen and diphenhydramine hydrochloride
Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime
0031-8770
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
20200615
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
OTC MONOGRAPH FINAL
part341
acetaminophen, dextromethorphan hbr
Robitussin Honey Severe Cough, Flu Plus Sore Throat
0031-8771
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
20200615
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
OTC MONOGRAPH FINAL
part341
acetaminophen
Robitussin Direct Sore Throat Pain
0031-9301
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
20220715
ACETAMINOPHEN
OTC MONOGRAPH NOT FINAL
500
part343
dextromethorphan hydrobromide
Robitussin Direct Cough
0031-9302
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
20220715
DEXTROMETHORPHAN HYDROBROMIDE
OTC MONOGRAPH FINAL
15
part341
guaifenesin
Robitussin Direct Chest Congestion
0031-9303
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
20220715
GUAIFENESIN
OTC MONOGRAPH FINAL
400
part341
diphenhydramine
Robitussin Direct Runny Nose
0031-9304
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
20220715
DIPHENHYDRAMINE HYDROCHLORIDE
OTC MONOGRAPH FINAL
25
part341
Phenylephrine hcl
Robitussin Direct Stuffy Nose
0031-9305
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
20220715
PHENYLEPHRINE HYDROCHLORIDE
OTC MONOGRAPH FINAL
10
part341
Pancrelipase
Creon
0032-1203
AbbVie Inc.
20090430
PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE
BLA
BLA020725
Pancrelipase
Creon
0032-1206
AbbVie Inc.
20090430
PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE
BLA
BLA020725
ESTRADIOL
ELESTRIN
0037-4801
Meda Pharmaceuticals
20140602
ESTRADIOL
NDA
0.52000000000000002
NDA021813
Zolpidem Tartrate
Edluar
0037-6010
Meda Pharmaceuticals Inc.
20090724
ZOLPIDEM TARTRATE
NDA
10
NDA021997
Zolpidem Tartrate
Edluar
0037-6050
Meda Pharmaceuticals Inc.
20090724
ZOLPIDEM TARTRATE
NDA
5
NDA021997
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