New and Generic Drug Approvals

Drug Name Active IngredientDosage Form/Route SponsorSubmission Type
Accupril quinapril hydrochlorideTablet;Oral Pfizer PharmsLabeling Revision
Accuretic hydrochlorothiazide; quinapril hydrochlorideTablet;Oral Pfizer PharmsLabeling Revision
Altace ramiprilCapsule;Oral King PharmsLabeling Revision
Arimidex anastrozoleTablet;Oral AstrazenecaLabeling Revision
Aromasin exemestaneTablet;Oral Pharmacia and UpjohnLabeling Revision
Chorionic Gonadotropin gonadotropin, chorionicInjectable;Injection FerringManufacturing Change or Addition
Osphena ospemifeneTablet;Oral Shionogi IncManufacturing Change or Addition
Zoledronic Acid zoledronic acidInjectable;Iv (Infusion) Acs Dobfar Info SaLabeling Revision

 

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