New and Generic Drug Approvals
September 8, 2014
September 8, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Boniva | ibandronate sodium | Injectable;Intravenous | Roche | Manufacturing Change or Addition |
| Brintellix | vortioxetine hydrobromide | Tablet;Oral | Takeda Pharms Usa | Manufacturing Change or Addition |
| Buprenorphine and Naloxone | buprenorphine hydrocloride; naloxone hydrochloride | Tablet;Sublingual | Teva Pharms Usa | Approval |
| Dextrose 10% In Plastic Container | dextrose | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Dextrose 5% and Lactated Ringer's In Plastic Container | calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Dextrose 5% and Sodium Chloride 0.45% In Plastic Container | dextrose; sodium chloride | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Dextrose 5% and Sodium Chloride 0.9% In Plastic Container | dextrose; sodium chloride | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Kalbitor | ecallantide | Injectable; Injection | Dyax Corp. | Labeling Revision |
| Lactated Ringer's In Plastic Container | calcium chloride; potassium chloride; sodium chloride; sodium lactate | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Nitrofurantoin | nitrofurantoin | Suspension;Oral | Novel Labs Inc | Approval |
| Normosol-M and Dextrose 5% In Plastic Container | dextrose; magnesium acetate; potassium acetate; sodium chloride | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Ondansetron Hydrochloride | ondansetron hydrochloride | Injectable;Injection | Qilu Pharma Co Ltd | Approval |
| Potassium Chloride 10meq In Dextrose 5% and Lactated Ringer's In Plastic Container | calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Potassium Chloride 10meq In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Potassium Chloride 10meq In Dextrose 5% and Sodium Chloride 0.9% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Potassium Chloride 15meq In Dextrose 5% and Lactated Ringer's In Plastic Container | calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Potassium Chloride 15meq In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Potassium Chloride 15meq In Dextrose 5% and Sodium Chloride 0.9% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Potassium Chloride 20meq In Dextrose 5% and Lactated Ringer's In Plastic Container | calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Potassium Chloride 20meq In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Potassium Chloride 20meq In Dextrose 5% and Sodium Chloride 0.9% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Potassium Chloride 20meq In Dextrose 5% In Plastic Container | dextrose; potassium chloride | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Potassium Chloride 20meq In Sodium Chloride 0.9% In Plastic Container | potassium chloride; sodium chloride | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Potassium Chloride 30meq In Dextrose 5% and Lactated Ringer's In Plastic Container | calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Potassium Chloride 30meq In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Potassium Chloride 30meq In Dextrose 5% and Sodium Chloride 0.9% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Potassium Chloride 30meq In Dextrose 5% In Plastic Container | dextrose; potassium chloride | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Potassium Chloride 40meq In Dextrose 5% and Lactated Ringer's In Plastic Container | calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Potassium Chloride 40meq In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Potassium Chloride 40meq In Dextrose 5% and Sodium Chloride 0.9% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Potassium Chloride 40meq In Dextrose 5% In Plastic Container | dextrose; potassium chloride | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Potassium Chloride 40meq In Sodium Chloride 0.9% In Plastic Container | potassium chloride; sodium chloride | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Potassium Chloride 5meq In Dextrose 5% and Lactated Ringer's In Plastic Container | calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Potassium Chloride 5meq In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Potassium Chloride 5meq In Dextrose 5% and Sodium Chloride 0.9% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Ringer's In Plastic Container | calcium chloride; potassium chloride; sodium chloride | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Sodium Chloride 0.45% In Plastic Container | sodium chloride | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Sodium Chloride 0.45% In Plastic Container | sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Sodium Chloride 0.9% In Plastic Container | sodium chloride | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Sodium Chloride 0.9% In Plastic Container | sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Sodium Chloride 3% In Plastic Container | sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Sodium Chloride 5% In Plastic Container | sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Velcade | bortezomib | Injectable;Intravenous, Subcutaneous | Millennium Pharms | Manufacturing Change or Addition |
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