New and Generic Drug Approvals
September 30, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Amoxil | amoxicillin | Tablet;Oral | Dr Reddys Labs Inc | Manufacturing Change or Addition |
| Ampyra | dalfampridine | Tablet, Extended Release;Oral | Acorda | Manufacturing Change or Addition |
| Augmentin '125' | amoxicillin; clavulanate potassium | For Suspension;Oral | Dr Reddys Labs Inc | Manufacturing Change or Addition |
| Augmentin '200' | amoxicillin; clavulanate potassium | For Suspension;Oral | Dr Reddys Labs Inc | Manufacturing Change or Addition |
| Augmentin '250' | amoxicillin; clavulanate potassium | Tablet;Oral | Dr Reddys Labs Inc | Manufacturing Change or Addition |
| Augmentin '250' | amoxicillin; clavulanate potassium | For Suspension;Oral | Dr Reddys Labs Inc | Manufacturing Change or Addition |
| Augmentin '400' | amoxicillin; clavulanate potassium | For Suspension;Oral | Dr Reddys Labs Inc | Manufacturing Change or Addition |
| Augmentin '500' | amoxicillin; clavulanate potassium | Tablet;Oral | Dr Reddys Labs Inc | Manufacturing Change or Addition |
| Augmentin '875' | amoxicillin; clavulanate potassium | Tablet;Oral | Dr Reddys Labs Inc | Manufacturing Change or Addition |
| Augmentin Es-600 | amoxicillin; clavulanate potassium | For Suspension;Oral | Dr Reddys Labs Inc | Manufacturing Change or Addition |
| Augmentin Xr | amoxicillin; clavulanate potassium | Tablet, Extended Release;Oral | Dr Reddys Labs Inc | Manufacturing Change or Addition |
| Azactam | aztreonam | Injectable;Injection | Bristol Myers Squibb | Manufacturing Change or Addition |
| Bloxiverz | neostigmine methylsulfate | Solution;Intravenous | Eclat Pharms Llc | Manufacturing Change or Addition |
| Brintellix | vortioxetine hydrobromide | Tablet;Oral | Takeda Pharms Usa | Manufacturing Change or Addition |
| Cambia | diclofenac potassium | For Solution;Oral | Depomed Inc | Manufacturing Change or Addition |
| Clinimix E 2.75/10 Sulfite-Free W/ Elect In Dextrose 10% W/ Calcium In Plastic Container | amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Clinimix E 2.75/25 Sulfite-Free W/ Elect In Dextrose 25% W/ Calcium In Plastic Container | amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Clinimix E 2.75/5 Sulfite-Free W/ Elect In Dextrose 5% W/ Calcium In Plastic Container | amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Clinimix E 4.25/10 Sulfite-Free W/ Elect In Dextrose 10% W/ Calcium In Plastic Container | amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Clinimix E 4.25/20 Sulfite-Free W/ Elect In Dextrose 20% W/ Calcium In Plastic Container | amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Clinimix E 4.25/25 Sulfite-Free W/ Elect In Dextrose 25% W/ Calcium In Plastic Container | amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Clinimix E 4.25/5 Sulfite-Free W/ Elect In Dextrose 5% W/ Calcium In Plastic Container | amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Clinimix E 5/10 Sulfite-Free W/ Elect In Dextrose 10% W/ Calcium In Plastic Container | amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Clinimix E 5/15 Sulfite-Free W/ Elect In Dextrose 15% W/ Calcium In Plastic Container | amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Clinimix E 5/20 Sulfite-Free W/ Elect In 20% Dextrose W/ Calcium In Plastic Container | amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Clinimix E 5/25 Sulfite-Free W/ Elect In Dextrose 25% W/ Calcium In Plastic Container | amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Clinimix E 5/35 Sulfite-Free W/ Elect In Dextrose 35% W/ Calcium In Plastic Container | amino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Clozaril | clozapine | Tablet;Oral | Novartis | Manufacturing Change or Addition |
| Dianeal 137 W/ Dextrose 1.5% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution;Intraperitoneal | Baxter Hlthcare | Manufacturing Change or Addition |
| Dianeal 137 W/ Dextrose 2.5% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution;Intraperitoneal | Baxter Hlthcare | Manufacturing Change or Addition |
| Dianeal 137 W/ Dextrose 4.25% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution;Intraperitoneal | Baxter Hlthcare | Manufacturing Change or Addition |
| Dianeal Low Calcium W/ Dextrose 1.5% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution;Intraperitoneal | Baxter Hlthcare | Manufacturing Change or Addition |
| Dianeal Low Calcium W/ Dextrose 2.5% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution;Intraperitoneal | Baxter Hlthcare | Manufacturing Change or Addition |
| Dianeal Low Calcium W/ Dextrose 3.5% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution;Intraperitoneal | Baxter Hlthcare | Manufacturing Change or Addition |
| Dianeal Low Calcium W/ Dextrose 4.25% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution;Intraperitoneal | Baxter Hlthcare | Manufacturing Change or Addition |
| Dianeal Pd-1 W/ Dextrose 1.5% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution;Intraperitoneal | Baxter Hlthcare | Manufacturing Change or Addition |
| Dianeal Pd-1 W/ Dextrose 2.5% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution;Intraperitoneal | Baxter Hlthcare | Manufacturing Change or Addition |
| Dianeal Pd-1 W/ Dextrose 3.5% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution;Intraperitoneal | Baxter Hlthcare | Manufacturing Change or Addition |
| Dianeal Pd-1 W/ Dextrose 4.25% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution;Intraperitoneal | Baxter Hlthcare | Manufacturing Change or Addition |
| Dianeal Pd-2 W/ Dextrose 1.5% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution;Intraperitoneal | Baxter Hlthcare | Manufacturing Change or Addition |
| Dianeal Pd-2 W/ Dextrose 1.5% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution;Intraperitoneal | Baxter Hlthcare | Manufacturing Change or Addition |
| Dianeal Pd-2 W/ Dextrose 2.5% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution;Intraperitoneal | Baxter Hlthcare | Manufacturing Change or Addition |
| Dianeal Pd-2 W/ Dextrose 2.5% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution;Intraperitoneal | Baxter Hlthcare | Manufacturing Change or Addition |
| Dianeal Pd-2 W/ Dextrose 3.5% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution;Intraperitoneal | Baxter Hlthcare | Manufacturing Change or Addition |
| Dianeal Pd-2 W/ Dextrose 4.25% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution;Intraperitoneal | Baxter Hlthcare | Manufacturing Change or Addition |
| Dianeal Pd-2 W/ Dextrose 4.25% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution;Intraperitoneal | Baxter Hlthcare | Manufacturing Change or Addition |
| Differin | adapalene | Lotion;Topical | Galderma Labs Lp | Manufacturing Change or Addition |
| Frova | frovatriptan succinate | Tablet;Oral | Endo Pharms | Manufacturing Change or Addition |
| Guanidine Hydrochloride | guanidine hydrochloride | Tablet;Oral | Merck Sharp Dohme | Manufacturing Change or Addition |
| Humira | adalimumab | Syringe | Abbvie Inc | Efficacy Supplement with Clinical Data to Support |
| Humira | adalimumab | Vial | Abbvie Inc | Efficacy Supplement with Clinical Data to Support |
| Humulin N | insulin susp isophane recombinant human | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Hyzaar | hydrochlorothiazide; losartan potassium | Tablet;Oral | Merck Sharp Dohme | Labeling Revision |
| Invanz | ertapenem sodium | Injectable;Intramuscular, Iv (Infusion) | Merck Sharp Dohme | Labeling Revision |
| K-Tab | potassium chloride | Tablet, Extended Release;Oral | Abbvie | Manufacturing Change or Addition |
| Lactated Ringer's and Dextrose 5% In Plastic Container | calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Lactated Ringer's In Plastic Container | calcium chloride; potassium chloride; sodium chloride; sodium lactate | Injectable;Injection | Baxter Hlthcare | 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 |
| Lactated Ringer's In Plastic Container | calcium chloride; potassium chloride; sodium chloride; sodium lactate | Solution;Irrigation | Baxter Hlthcare | Manufacturing Change or Addition |
| Lazanda | fentanyl citrate | Spray, Metered;Nasal | Depomed Inc | Manufacturing Change or Addition |
| Mestinon | pyridostigmine bromide | Syrup;Oral | Valeant Pharm North | Manufacturing Change or Addition |
| Northera | droxidopa | Capsule;Oral | Lundbeck Na Ltd | Manufacturing Change or Addition |
| Nulojix | belatacept | Injectable; Injection | Bristol Myers Squibb | Labeling Revision |
| Omega-3-Acid Ethyl Esters | omega-3-acid ethyl esters | Capsule;Oral | Apotex Inc | Approval |
| Potassium Chloride | potassium chloride | Tablet, Extended Release;Oral | Abbvie | Manufacturing Change or Addition |
| Potassium Chloride 10meq In Dextrose 5% and Lactated Ringer's In Plastic Container | calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate | Injectable;Injection | Baxter Hlthcare | 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 | Baxter Hlthcare | 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 | Baxter Hlthcare | 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 | Baxter Hlthcare | 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 | Baxter Hlthcare | 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 | Baxter Hlthcare | Manufacturing Change or Addition |
| Prometrium | progesterone | Capsule;Oral | Abbvie Inc | Manufacturing Change or Addition |
| Prometrium | progesterone | Capsule; Oral | Abbvie Inc | Manufacturing Change or Addition |
| Pyridostigmine Bromide | pyridostigmine bromide | Tablet;Oral | Us Army | Manufacturing Change or Addition |
| Raltegravir | raltegravir | Tablet;Oral | Hetero Labs Ltd Iii | Tentative Approval |
| Remeron | mirtazapine | Tablet;Oral | Organon Usa Inc | Manufacturing Change or Addition |
| Remeron Soltab | mirtazapine | Tablet, Orally Disintegrating;Oral | Organon Usa Inc | Manufacturing Change or Addition |
| Ringer's In Plastic Container | calcium chloride; potassium chloride; sodium chloride | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Ringer's In Plastic Container | calcium chloride; potassium chloride; sodium chloride | Solution;Irrigation | Baxter Hlthcare | Manufacturing Change or Addition |
| Saizen | somatropin recombinant | Injectable;Injection | Emd Serono | 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 |
| Surmontil | trimipramine maleate | Capsule;Oral | Odyssey Pharms | Manufacturing Change or Addition |
| Tasmar | tolcapone | Tablet;Oral | Valeant Pharms Llc | Manufacturing Change or Addition |
| Tobi Podhaler | tobramycin | Powder;Inhalation | Novartis | Manufacturing Change or Addition |
| Ultresa | pancrelipase (amylase;lipase;protease) | Capsule, Delayed Release;Oral | Forest Labs Inc | Manufacturing Change or Addition |
| Vytorin | ezetimibe; simvastatin | Tablet;Oral | Msd Intl | Labeling Revision |
| Yasmin | drospirenone; ethinyl estradiol | Tablet;Oral-28 | Bayer Hlthcare | Manufacturing Change or Addition |
| Yaz | drospirenone; ethinyl estradiol | Tablet;Oral | Bayer Hlthcare | Manufacturing Change or Addition |
| Zetia | ezetimibe | Tablet;Oral | Msd Intl Gmbh | Labeling Revision |
| Zyprexa | olanzapine | Injectable;Intramuscular | Lilly | Manufacturing Change or Addition |
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