New and Generic Drug Approvals

Drug Name Active IngredientDosage Form/Route SponsorSubmission Type
Budesonide budesonideSpray, Metered;Nasal Apotex IncApproval
Hydromorphone Hydrochloride hydromorphone hydrochlorideTablet, Extended Release;Oral Actavis IncApproval
Lo-Blisovi Fe norethindrone acetate;ethinyl estradiol;ferrous fumarate Tablet;OralLupin Ltd Tentative Approval
Olanzapine olanzapineTablet, Orally Disintegrating;Oral Mylan Pharms IncApproval
Rayos prednisoneTablet, Delayed Release;Oral Horizon PharmaManufacturing Change or Addition
Tivicay dolutegravir sodiumTablet;Oral Viiv HlthcareLabeling Revision
Topicort desoximetasoneOintment;Topical Taro Pharms NorthManufacturing Change or Addition
Toprol-Xl metoprolol succinateTablet, Extended Release;Oral AstrazenecaManufacturing Change or Addition
Zirgan ganciclovirGel;Ophthalmic Bausch and LombManufacturing Change or Addition

 

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