CDER New December 30, 2014

FDA (U.S. Food and Drug Administration)

What's New on the FDA Drugs Site

December 29, 2014


New and Generic Drug Approvals

December 24, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Abstral fentanyl citrate Tablet;Sublingual Galena Biopharma Supplement
Actiq fentanyl citrate Troche/Lozenge;Transmucosal Cephalon Supplement
Capoten captopril Tablet;Oral Par Pharm Labeling Revision
Fentora fentanyl citrate Tablet;Buccal, Sublingual Cephalon Supplement
Lazanda fentanyl citrate Spray, Metered;Nasal Depomed Inc Labeling Revision
Lazanda fentanyl citrate Spray, Metered;Nasal Depomed Inc Supplement
Lotrel amlodipine besylate; benazepril hydrochloride Capsule;Oral Novartis Labeling Revision
Mavik trandolapril Tablet;Oral Abbvie Labeling Revision
Onsolis fentanyl citrate Film;Buccal Meda Pharms Supplement
Subsys fentanyl Spray;Sublingual Insys Therap Labeling Revision
Subsys fentanyl Spray;Sublingual Insys Therap Supplement
Tarka trandolapril; verapamil hydrochloride Tablet, Extended Release;Oral Abbvie Labeling Revision
Vaseretic enalapril maleate; hydrochlorothiazide Tablet;Oral Valeant Intl Labeling Revision
Vasotec enalapril maleate Tablet;Oral Valeant Intl Labeling Revision
Zestoretic hydrochlorothiazide; lisinopril Tablet;Oral Astrazeneca Labeling Revision
Zestril lisinopril Tablet;Oral Astrazeneca Labeling Revision
Zyban bupropion hydrochloride Tablet, Extended Release;Oral Glaxosmithkline Labeling Revision

 

December 23, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Depocyt cytarabine Injectable, Liposomal;Injection Pacira Pharms Inc Labeling Revision
Dyloject diclofenac sodium Injectable;Injection Javelin Pharms Inc Approval
Namzaric memantine hydrochloride;donepezil hydrochloride Capsule;Oral Forest Labs Inc Approval
Neulasta pegfilgrastim Syringe Amgen Manufacturing Change or Addition
Retrovir zidovudine Capsule;Oral Viiv Hlthcare Labeling Revision
Retrovir zidovudine Syrup;Oral Viiv Hlthcare Labeling Revision
Retrovir zidovudine Injectable;Injection Viiv Hlthcare Labeling Revision
Retrovir zidovudine Tablet;Oral Viiv Hlthcare Labeling Revision
Taclonex betamethasone dipropionate; calcipotriene hydrate Ointment;Topical Leo Pharma As Efficacy Supplement with Clinical Data to Support
Tylenol acetaminophen Tablet, Extended Release;Oral Mcneil Cons Labeling Revision

 


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