New and Generic Drug Approvals
September 17, 2014
September 17, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Amoxapine | amoxapine | Tablet;Oral | Watson Labs | Labeling Revision |
| Citalopram Hydrobromide | citalopram hydrobromide | Solution;Oral | Roxane | Labeling Revision |
| Daliresp | roflumilast | Tablet;Oral | Forest Res Inst Inc | Manufacturing Change or Addition |
| Dextrose 5% and Sodium Chloride 0.45% In Plastic Container | dextrose; sodium chloride | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Docetaxel | docetaxel | Injectable;Injection | Actavis Inc | Labeling Revision |
| Lactated Ringer's In Plastic Container | calcium chloride; potassium chloride; sodium chloride; sodium lactate | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Serostim | somatropin recombinant | Injectable;Injection | Emd Serono | Manufacturing Change or Addition |
| Serostim Lq | somatropin recombinant | Injectable;Subcutaneous | Emd Serono | Manufacturing Change or Addition |
| Sodium Chloride 0.45% In Plastic Container | sodium chloride | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Sodium Chloride 0.9% In Plastic Container | sodium chloride | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Stendra | avanafil | Tablet;Oral | Vivus | Efficacy Supplement with Clinical Data to Support |
| Tofranil | imipramine hydrochloride | Tablet;Oral | Mallinckrodt Inc | Labeling Revision |
| Venlafaxine Hydrochloride | venlafaxine hydrochloride | Tablet;Oral | Teva | Labeling Revision |
| Vivactil | protriptyline hydrochloride | Tablet;Oral | Odyssey Pharms | Labeling Revision |
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