USFDA: New and Generic Drug Approvals: 26 SEP 2014

New and Generic Drug Approvals

September 26, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Acetic Acid 0.25% In Plastic Container acetic acid, glacial Solution;Irrigation, Urethral Baxter Hlthcare Manufacturing Change or Addition
Allopurinol allopurinol Tablet;Oral Watson Labs Manufacturing Change or Addition
Aminoacetic Acid 1.5% In Plastic Container glycine Solution;Irrigation Baxter Hlthcare Manufacturing Change or Addition
Cubicin daptomycin Injectable;Iv (Infusion) Cubist Manufacturing Change or Addition
Dextrose 5% In Sodium Chloride 0.2% In Plastic Container dextrose; sodium chloride Injectable;Injection Baxter Hlthcare Manufacturing Change or Addition
Dextrose 5% In Sodium Chloride 0.33% In Plastic Container dextrose; sodium chloride Injectable;Injection Baxter Hlthcare Manufacturing Change or Addition
Dextrose 5%, Sodium Chloride 0.45% and Potassium Chloride 15meq In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection Baxter Hlthcare Manufacturing Change or Addition
Dextrose 5%, Sodium Chloride 0.45% and Potassium Chloride 20meq (K) In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection Baxter Hlthcare Manufacturing Change or Addition
Dextrose 5%, Sodium Chloride 0.45% and Potassium Chloride 5meq In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection Baxter Hlthcare Manufacturing Change or Addition
Diclofenac Sodium diclofenac sodium Spray;Topical Watson Labs Tentative Approval
Diovan valsartan Tablet;Oral Novartis Labeling Revision
Elidel pimecrolimus Cream;Topical Valeant Bermuda Manufacturing Change or Addition
Firmagon degarelix acetate Powder;Subcutaneous Ferring Manufacturing Change or Addition
Hicon sodium iodide i-131 Solution;Oral Jubilant Draximage Manufacturing Change or Addition
Lactated Ringer's In Plastic Container calcium chloride; potassium chloride; sodium chloride; sodium lactate Solution;Irrigation Baxter Hlthcare Manufacturing Change or Addition
Letairis ambrisentan Tablet;Oral Gilead Manufacturing Change or Addition
Linezolid linezolid sodium chloride Injectable;Injection Hospira Inc Tentative Approval
Lluvien fluocinolone acetonide Insert;Intravitreal Alimera Sciences Inc Approval
Loestrin 21 1.5/30 ethinyl estradiol; norethindrone acetate Tablet;Oral-21 Warner Chilcott Llc Manufacturing Change or Addition
Loestrin 21 1/20 ethinyl estradiol; norethindrone acetate Tablet;Oral-21 Warner Chilcott Llc Manufacturing Change or Addition
Loestrin Fe 1/20 ethinyl estradiol; norethindrone acetate Tablet;Oral-28 Warner Chilcott Manufacturing Change or Addition
Mekinist trametinib dimethyl sulfoxide Tablet;Oral Glaxosmithkline Llc Manufacturing Change or Addition
Mitigare colchicine Capsule;Oral Hikma Pharms Llc Approval
Namenda Xr memantine hydrochloride Capsule, Extended Release;Oral Forest Labs Labeling Revision
Potassium Chloride 10meq In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container dextrose; potassium chloride; sodium chloride Injectable;Injection Baxter Hlthcare 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 Baxter Hlthcare 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 Baxter Hlthcare 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 Baxter Hlthcare 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 Baxter Hlthcare Manufacturing Change or Addition
Protonix Iv pantoprazole sodium Injectable;Iv (Infusion) Wyeth Pharms Inc Manufacturing Change or Addition
Qsymia phentermine hydrochloride; topiramate Capsule, Extended Release;Oral Vivus Labeling Revision
Qsymia phentermine hydrochloride; topiramate Capsule, Extended Release;Oral Vivus Supplement
Sodium Iodide I-131 sodium iodide i-131 Capsule;Oral Jubilant Draximage Manufacturing Change or Addition
Sterile Water For Injection In Plastic Container sterile water for injection Liquid;N/A Baxter Hlthcare Manufacturing Change or Addition
Sterile Water In Plastic Container sterile water for irrigation Liquid;Irrigation Baxter Hlthcare Manufacturing Change or Addition
Tagamet Hb cimetidine Tablet;Oral Medtech Prods Manufacturing Change or Addition
Xolair omalizumab Vial Genentech Efficacy Supplement with Clinical Data to Support
Zenpep pancrelipase (amylase;lipase;protease) Capsule, Delayed Release;Oral Forest Labs Inc Manufacturing Change or Addition
Zutripro chlorpheniramine maleate; hydrocodone bitartrate; pseudoephedrine hydrochloride Solution;Oral Cypress Pharm Manufacturing Change or Addition
Zyrtec Allergy cetirizine hydrochloride Tablet;Oral Mcneil Consumer Manufacturing Change or Addition
Zyrtec Hives Relief cetirizine hydrochloride Tablet;Oral Mcneil Consumer Manufacturing Change or Addition

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