Established Name
Proprietary Name
Applicant
Approval Date
NDA Chemical Type
Notes
Diclofenac Epolamine Topical PatchFlector® PatchInstitut Biochimique SA1/31/20072Letter
SBA
Clobetasol Propionate FoamOlux-EConnetics Corporation1/12/20075Letter
SBA
Cyclobenzaprine Hydrochloride Extended-Release CapsulesAMRIXECR Pharmaceuticals2/1/20073Letter
SBA
Zolpidem Tartrate Orally Disintegrating TabletsTovalt ODTBiovail4/25/20073Letter
SBA
Formoterol Fumarate Inhalation SolutionPerformistDey6/11/20073Letter
SBA
Levocetirizine DihydrochlorideXyzalUCB5/5/20075Letter
SBA
Ketoconazole FoamExtinaStiefel Labs6/12/20073Letter
SBA
Tretinoin GelAtralinDow Pharma Sciences7/26/20073Letter
SBA
Cyanocobalamin Nasal SprayCalomistFleming & Co.7/27/20075Letter
SBA
Lidocaine HydrochlorideZingoAnesiva8/16/20073Letter
SBA
Fenofibrate TabletsFenoglideShionogi Pharma8/10/20075Letter
SBA
Ammonia, N-13Ammonia N 13Feinstein8/23/20071Letter
SBA
Levothyroxin Sodium TabletsTirosintInst Biochimique8/1/20073Letter
SBA
Dexrazoxane for injectionTotectTopoTarget9/6/20075Letter
SBA
Amlodipine Besylate Orally Disintegrating TabletsAmlodipine BesylateSynthon Pharma9/27/20073Letter
SBA
Fludarabine Phosphate InjectionFludarabine PhosphateEbewe Pharma9/21/20075Letter
SBA
Simvastatin Orally Disintegrating TabletsSimvastatinSynthon Pharms10/9/20073Letter
SBA
Diclofenac SodiumVoltarenNovaris10/17/20073Letter
SBA
Triamcinolone Acetonide Injectable SuspensionTriesenceAlcon11/29/20073Letter
SBA
Omeprazole Delayed Release TabletsOmeprazoleDexcel Pharma12/4/20075Letter
SBA
Metformin Hydrochloride; Sitagliptin PhosphateJanumetMerck3/30/20074Letter
SBA
Amlodipine Besylate; ValsartanExforgeNovartis6/20/20074Letter
SBA
Amlodipine Besylate;Olmesartan MedoxomilAZORDaiichi Sanko9/26/20074Letter
SBA
Brimonidine Tartrate; Timolol MaleateCombiganAllergan10/30/20074Letter
SBA