New and Generic Drug Approvals

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Drug Name Active IngredientDosage Form/Route SponsorSubmission Type
Clopidogrel clopidogrelTablet; Oral Amneal PharmsApproval
Fortaz In Plastic Container ceftazidime sodiumInjectable;Injection Covis PharmaManufacturing Change or Addition
Forteo teriparatide recombinant humanInjectable;Subcutaneous LillyManufacturing 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 recombinantInjectable;Injection LillyManufacturing Change or Addition
Humalog Mix 50/50 Kwikpen insulin lispro protamine recombinant; insulin lispro recombinantInjectable;Injection LillyManufacturing Change or Addition
Humalog Mix 50/50 Pen insulin lispro protamine recombinant; insulin lispro recombinantInjectable;Injection LillyManufacturing Change or Addition
Humalog Mix 75/25 insulin lispro protamine recombinant; insulin lispro recombinantInjectable;Injection LillyManufacturing Change or Addition
Humalog Mix 75/25 Kwikpen insulin lispro protamine recombinant; insulin lispro recombinantInjectable;Injection LillyManufacturing Change or Addition
Humalog Mix 75/25 Pen insulin lispro protamine recombinant; insulin lispro recombinantInjectable;Injection LillyManufacturing Change or Addition
Humalog Pen insulin lispro recombinantInjectable;Injection LillyManufacturing Change or Addition
Humatrope somatropin recombinantInjectable;Injection LillyManufacturing Change or Addition
Humulin 70/30 insulin recombinant human; insulin susp isophane recombinant humanInjectable;Injection LillyManufacturing Change or Addition
Humulin 70/30 Pen insulin recombinant human; insulin susp isophane recombinant humanInjectable;Injection LillyManufacturing Change or Addition
Humulin N insulin susp isophane recombinant humanInjectable;Injection LillyManufacturing Change or Addition
Lidocaine Hydrochloride lidocaine hydrochlorideInjectable; Injection Agila SpecltsApproval
Ortho Evra ethinyl estradiol; norelgestrominFilm, Extended Release;Transdermal Janssen PharmsLabeling Revision
Premarin estrogens, conjugatedTablet;Oral Wyeth Pharms IncManufacturing Change or Addition
Sporanox itraconazoleCapsule;Oral Janssen PharmsManufacturing Change or Addition
Vimpat lacosamideSolution;Oral Ucb IncManufacturing Change or Addition
Xyrem sodium oxybateSolution;Oral Jazz PharmsEfficacy Supplement with Clinical Data to Support

 

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