What's New on the FDA Drugs Site
October 21, 2013
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- National Drug Code Directory
New and Generic Drug Approvals
October 18, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Allegra-D 24 Hour Allergy and Congestion | fexofenadine hydrochloride; pseudoephedrine hydrochloride | Tablet, Extended Release;Oral | Sanofi Aventis Us | Manufacturing Change or Addition |
| Antara (Micronized) | fenofibrate | Capsule;Oral | Lupin Atlantis | Manufacturing Change or Addition |
| Asacol | mesalamine | Tablet, Delayed Release;Oral | Warner Chilcott Llc | Efficacy Supplement with Clinical Data to Support |
| Asacol Hd | mesalamine | Tablet, Delayed Release;Oral | Warner Chilcott Llc | Efficacy Supplement with Clinical Data to Support |
| Bicnu | carmustine | Injectable;Injection | Emcure Pharms Ltd | Labeling Revision |
| Claritin-D | loratadine; pseudoephedrine sulfate | Tablet, Extended Release;Oral | Schering Plough | Manufacturing Change or Addition |
| Diovan | valsartan | Tablet;Oral | Novartis | Manufacturing Change or Addition |
| Duoneb | albuterol sulfate; ipratropium bromide | Solution;Inhalation | Dey | Manufacturing Change or Addition |
| Entereg | alvimopan | Capsule;Oral | Cubist Pharms | Efficacy Supplement with Clinical Data to Support |
| Fioricet W/ Codeine | acetaminophen; butalbital; caffeine; codeine phosphate | Capsule;Oral | Watson Labs Inc | Labeling Revision |
| Infasurf Preservative Free | calfactant | Suspension;Intratracheal | Ony | Manufacturing Change or Addition |
| Lamivudine; Tenofovir Disoproxil Fumarate; Nevirapine | lamivudine; tenofovir disoproxil fumarate; nevirapine | Tablet; Oral | Aurobindo Pharma Ltd | Tentative Approval |
| Lantus | insulin glargine recombinant | Injectable;Injection | Sanofi Aventis Us | Efficacy Supplement with Clinical Data to Support |
| Lantus Solostar | insulin glargine recombinant | Injectable;Injection | Sanofi Aventis Us | Efficacy Supplement with Clinical Data to Support |
| Ofirmev | acetaminophen | Solution;Iv (Infusion) | Cadence Pharms | Labeling Revision |
| Opsumit | macitentan | Tablet; Oral | Actelion Pharms Ltd | Approval |
| Pradaxa | dabigatran etexilate mesylate | Capsule;Oral | Boehringer Ingelheim | Manufacturing Change or Addition |
| Prismasol B22gk 2/0 In Plastic Container | calcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride | Injectable;Injection | Gambro Renal Prods | Manufacturing Change or Addition |
| Prismasol B22gk 2/2.5 In Plastic Container | calcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride | Injectable;Injection | Gambro Renal Prods | Manufacturing Change or Addition |
| Prismasol B22gk 4/0 In Plastic Container | calcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride | Injectable;Injection | Gambro Renal Prods | Manufacturing Change or Addition |
| Prismasol B22gk 4/2.5 In Plastic Container | calcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride | Injectable;Injection | Gambro Renal Prods | Manufacturing Change or Addition |
| Prismasol Bgk 0/2.5 In Plastic Container | calcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride | Injectable;Injection | Gambro Renal Prods | Manufacturing Change or Addition |
| Prismasol Bgk 2/0 In Plastic Container | calcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride | Injectable;Injection | Gambro Renal Prods | Manufacturing Change or Addition |
| Prismasol Bgk 2/3.5 In Plastic Container | calcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride | Injectable;Injection | Gambro Renal Prods | Manufacturing Change or Addition |
| Prismasol Bgk 4/0 In Plastic Container | calcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride | Injectable;Injection | Gambro Renal Prods | Manufacturing Change or Addition |
| Prismasol Bgk 4/0/1.2 In Plastic Container | calcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride | Injectable;Injection | Gambro Renal Prods | Manufacturing Change or Addition |
| Prismasol Bgk 4/2.5 In Plastic Container | calcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride | Injectable;Injection | Gambro Renal Prods | Manufacturing Change or Addition |
| Prismasol Bgk 4/3.5 In Plastic Container | calcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride | Injectable;Injection | Gambro Renal Prods | Manufacturing Change or Addition |
| Prismasol Bk 0/0 In Plastic Container | calcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride | Injectable;Injection | Gambro Renal Prods | Manufacturing Change or Addition |
| Prismasol Bk 0/0/1.2 In Plastic Container | calcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride | Injectable;Injection | Gambro Renal Prods | Manufacturing Change or Addition |
| Prismasol Bk 0/3.5 In Plastic Container | calcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride | Injectable;Injection | Gambro Renal Prods | Manufacturing Change or Addition |
| Prismasol Bk 4/2.5 In Plastic Container | calcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride | Injectable;Injection | Gambro Renal Prods | Manufacturing Change or Addition |
| Procysbi | cysteamine bitartrate | Capsule, Delayed Release;Oral | Raptor Pharms | Manufacturing Change or Addition |
| Tri-Luma | fluocinolone acetonide; hydroquinone; tretinoin | Cream;Topical | Galderma Labs Lp | Manufacturing Change or Addition |
| Tykerb | lapatinib ditosylate | Tablet;Oral | Smithkline Beecham | Efficacy Supplement with Clinical Data to Support |
| Ultracet | acetaminophen; tramadol hydrochloride | Tablet;Oral | Janssen Pharms | Labeling Revision |
| Zorvolex | diclofenac | Capsule;Oral | Iroko Pharms | Approval |
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