New and Generic Drug Approvals

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June 12, 2014

Drug NameActive Ingredient Dosage Form/RouteSponsor Submission Type
Acetic Acid 0.25% In Plastic Container acetic acid, glacialSolution;Irrigation, Urethral HospiraManufacturing Change or Addition
Bacteriostatic Sodium Chloride 0.9% In Plastic Container sodium chlorideInjectable;Injection HospiraManufacturing Change or Addition
Bacteriostatic Water For Injection In Plastic Container sterile water for injectionLiquid;N/A HospiraManufacturing Change or Addition
Caverject alprostadilInjectable;Injection Pharmacia and UpjohnLabeling Revision
Cerebyx fosphenytoin sodiumInjectable;Injection Parke DavisLabeling Revision
Chromic Chloride In Plastic Container chromic chlorideInjectable;Injection HospiraManufacturing Change or Addition
Cupric Chloride In Plastic Container cupric chlorideInjectable;Injection HospiraManufacturing Change or Addition
Dovonex calcipotrieneCream;Topical Leo Pharma AsManufacturing Change or Addition
Ella ulipristal acetateTablet;Oral Lab Hra PharmaLabeling Revision
Heparin Sodium heparin sodiumInjectable;Injection Shenzhen Techdow PharmaApproval
Heparin Sodium heparin sodiumInjectable;Injection Shenzhen Techdow PharmaApproval
Heparin Sodium heparin sodiumInjectable;Injection Shenzhen Techdow PharmaApproval
Heparin Sodium heparin sodiumInjectable;Injection Shenzhen Techdow PharmaApproval
Lamotrigine lamotrigineTablet, Chewable;Oral Alembic Pharms LtdApproval
Manganese Chloride In Plastic Container manganese chlorideInjectable;Injection HospiraManufacturing Change or Addition
Physiosol In Plastic Container magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium gluconate Solution;IrrigationHospira Manufacturing Change or Addition
Potassium Acetate In Plastic Container potassium acetateInjectable;Injection HospiraManufacturing Change or Addition
Ringer's In Plastic Container calcium chloride; potassium chloride; sodium chlorideSolution;Irrigation HospiraManufacturing Change or Addition
Sodium Acetate In Plastic Container sodium acetate anhydrousInjectable;Injection HospiraManufacturing Change or Addition
Sodium Chloride 0.9% In Plastic Container sodium chlorideSolution;Irrigation HospiraManufacturing Change or Addition
Sodium Chloride 0.9% In Plastic Container sodium chlorideInjectable;Injection HospiraManufacturing Change or Addition
Sodium Chloride In Plastic Container sodium chlorideInjectable;Injection HospiraManufacturing Change or Addition
Sodium Lactate In Plastic Container sodium lactateInjectable;Injection HospiraManufacturing Change or Addition
Sodium Phosphates In Plastic Container sodium phosphate, dibasic, heptahydrate; sodium phosphate, monobasic, anhydrous Injectable;InjectionHospira Manufacturing Change or Addition
Sterile Water For Injection In Plastic Container sterile water for injectionLiquid;N/A HospiraManufacturing Change or Addition
Taclonex betamethasone dipropionate; calcipotriene hydrateOintment;Topical Leo Pharma AsManufacturing Change or Addition
Timentin clavulanate potassium; ticarcillin disodiumInjectable;Injection GlaxosmithklineLabeling Revision
Timentin In Plastic Container clavulanate potassium; ticarcillin disodiumInjectable;Injection GlaxosmithklineLabeling Revision
Tpn Electrolytes In Plastic Container calcium chloride; magnesium chloride; potassium chloride; sodium acetate; sodium chloride Injectable;InjectionHospira Manufacturing Change or Addition
Zebeta bisoprolol fumarateTablet;Oral Teva WomensManufacturing Change or Addition
Ziac bisoprolol fumarate; hydrochlorothiazideTablet;Oral Teva WomensManufacturing Change or Addition
Zinc Chloride In Plastic Container zinc chlorideInjectable;Injection HospiraManufacturing Change or Addition

 

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