Wednesday, 17 July 2013

CDER New July 17, 2013

FDA (U.S. Food and Drug Administration)

What's New on the FDA Drugs Site

July 16, 2013


New and Generic Drug Approvals

July 15, 2013

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Corgard nadolol Tablet; Oral King Pharms Labeling Revision
Corzide bendroflumethiazide; nadolol Tablet; Oral King Pharms Labeling Revision
Femhrt ethinyl estradiol; norethindrone acetate Tablet; Oral Warner Chilcott Llc Manufacturing Change or Addition
Heparin Sodium 1,000 Units In Sodium Chloride 0.9% In Plastic Container heparin sodium Injectable; Injection Hospira Manufacturing Change or Addition
Heparin Sodium 10,000 Units In Sodium Chloride 0.45% heparin sodium Injectable; Injection Hospira Manufacturing Change or Addition
Heparin Sodium 10,000 Units In Sodium Chloride 0.9% heparin sodium Injectable; Injection Hospira Manufacturing Change or Addition
Heparin Sodium 12,500 Units In Sodium Chloride 0.45% In Plastic Container heparin sodium Injectable; Injection Hospira Manufacturing Change or Addition
Heparin Sodium 12,500 Units In Sodium Chloride 0.9% heparin sodium Injectable; Injection Hospira Manufacturing Change or Addition
Heparin Sodium 2,000 Units In Sodium Chloride 0.9% In Plastic Container heparin sodium Injectable; Injection Hospira Manufacturing Change or Addition
Heparin Sodium 25,000 Units In Sodium Chloride 0.45% In Plastic Container heparin sodium Injectable; Injection Hospira Manufacturing Change or Addition
Heparin Sodium 25,000 Units In Sodium Chloride 0.9% In Plastic Container heparin sodium Injectable; Injection Hospira Manufacturing Change or Addition
Heparin Sodium 5,000 Units In Sodium Chloride 0.45% heparin sodium Injectable; Injection Hospira Manufacturing Change or Addition
Heparin Sodium 5,000 Units In Sodium Chloride 0.9% heparin sodium Injectable; Injection Hospira Manufacturing Change or Addition
Mirapex Er pramipexole dihydrochloride Tablet, Extended Release; Oral Boehringer Ingelheim Manufacturing Change or Addition

 


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