New and Generic Drug Approvals

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Drug Name Active IngredientDosage Form/Route SponsorSubmission Type
Amitriptyline Hydrochloride amitriptyline hydrochlorideTablet;Oral Accord Hlthcare IncApproval
Byetta exenatide syntheticInjectable;Subcutaneous Astrazeneca AbManufacturing Change or Addition
Cefepime In Plastic Container cefepime hydrochlorideInjectable;Injection Baxter HlthcareLabeling Revision
Cevimeline Hydrochloride cevimeline hydrochlorideCapsule;Oral Pack Pharms LlcApproval
Elidel pimecrolimusCream;Topical Valeant BermudaManufacturing Change or Addition
Fortesta testosteroneGel, Metered;Transdermal Endo PharmsManufacturing Change or Addition
Humalog insulin lispro recombinantInjectable;Injection LillyManufacturing Change or Addition
Humalog Kwikpen insulin lispro recombinantInjectable;Injection LillyManufacturing Change or Addition
Humalog Mix 50/50 insulin lispro protamine recombinant; insulin lispro recombinant Injectable;InjectionLilly Manufacturing Change or Addition
Humalog Mix 50/50 Kwikpen insulin lispro protamine recombinant; insulin lispro recombinant Injectable;InjectionLilly Manufacturing Change or Addition
Humalog Mix 50/50 Pen insulin lispro protamine recombinant; insulin lispro recombinant Injectable;InjectionLilly Manufacturing Change or Addition
Humalog Mix 75/25 insulin lispro protamine recombinant; insulin lispro recombinant Injectable;InjectionLilly Manufacturing Change or Addition
Humalog Mix 75/25 Kwikpen insulin lispro protamine recombinant; insulin lispro recombinant Injectable;InjectionLilly Manufacturing Change or Addition
Humalog Mix 75/25 Pen insulin lispro protamine recombinant; insulin lispro recombinant Injectable;InjectionLilly Manufacturing Change or Addition
Humalog Pen insulin lispro recombinantInjectable;Injection LillyManufacturing Change or Addition
Humulin 70/30 insulin recombinant human; insulin susp isophane recombinant human Injectable;InjectionLilly Manufacturing Change or Addition
Humulin 70/30 Pen insulin recombinant human; insulin susp isophane recombinant human Injectable;InjectionLilly Manufacturing Change or Addition
Humulin N insulin susp isophane recombinant humanInjectable;Injection LillyManufacturing Change or Addition
Levothyroxine Sodium levothyroxine sodiumInjectable; Injection Fresenius Kabi UsaManufacturing Change or Addition
Levothyroxine Sodium levothyroxine sodiumPowder;Intravenous Fresenius Kabi UsaManufacturing Change or Addition
Prandimet metformin hydrochloride; repaglinideTablet;Oral Novo Nordisk IncManufacturing Change or Addition
Prolia denosumabInjectable; Subcutaneous AmgenLabeling Revision
Vimpat lacosamideTablet;Oral Ucb IncManufacturing Change or Addition
Vogelxo testosteroneGel; Transdermal Upsher Smith LabsApproval
Xgeva denosumabInjectable; Subcutaneous AmgenLabeling Revision

 

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