CDER New March 26, 2014

FDA (U.S. Food and Drug Administration)

What's New on the FDA Drugs Site

March 25, 2014


New and Generic Drug Approvals

March 24, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Adenosine adenosine Injectable;Injection Hospira Inc Approval
Adrenaclick epinephrine Injectable;Intramuscular, Subcutaneous Amedra Pharms Manufacturing Change or Addition
Betamethasone Valerate betamethasone valerate Lotion;Topical Fougera Manufacturing Change or Addition
Bydureon exenatide synthetic For Suspension, Extended Release;Subcutaneous Amylin Manufacturing Change or Addition
Diflucan fluconazole Tablet;Oral Pfizer Labeling Revision
Diflucan fluconazole For Suspension;Oral Pfizer Labeling Revision
Diflucan In Dextrose 5% In Plastic Container fluconazole Injectable;Injection Pfizer Labeling Revision
Diflucan In Sodium Chloride 0.9% fluconazole Injectable;Injection Pfizer Labeling Revision
Diflucan In Sodium Chloride 0.9% In Plastic Container fluconazole Injectable;Injection Pfizer Labeling Revision
Fortesta testosterone Gel, Metered;Transdermal Endo Pharms Labeling Revision
Memantine Hydrochloride memantine hydrochloride Tablet; Oral Aurobindo Pharma Ltd Tentative Approval
Metronidazole metronidazole Gel;Vaginal Valeant Pharms Approval
Prevantics Maxi Swabstick chlorhexidine gluconate; isopropyl alcohol Swab;Topical Prof Dspls Labeling Revision
Prevantics Swab chlorhexidine gluconate; isopropyl alcohol Swab;Topical Prof Dspls Labeling Revision
Prevantics Swabstick chlorhexidine gluconate; isopropyl alcohol Swab;Topical Prof Dspls Labeling Revision
Twinject 0.15 epinephrine Injectable;Intramuscular, Subcutaneous Amedra Pharms Manufacturing Change or Addition
Twinject 0.3 epinephrine Injectable;Intramuscular, Subcutaneous Amedra Pharms Manufacturing Change or Addition

 


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