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 CDER Drug and Biologic Approvals for Calendar Year 2004
Updated through December 31, 2004

All New Drug Application (NDA) Approvals:

NDA Number Proprietary Name Established Name Applicant Chemical Type Review Classification Approval Date
N021604 Children's Elixsure IB Ibuprofen Taro Pharms 5 S 07-Jan-04
N021539 Acetadote Acetylcysteine Cumberland Pharms 3 P, O 23-Jan-04
N021646 Infuvite Pediatric Multiple Vitamins Sabex 2002 5 S 29-Jan-04
N021395 Spiriva Handihaler Tiotropium Bromide Boehringer Ingelheim 1 S 30-Jan-04
N021540 Caduet Amlodipine Besylate; Atorvastatin Calcium Pfizer 4 S 30-Jan-04
N021625 MVI Adult Multi-Vitamins aaiPharma 3 S 30-Jan-04
N021462 Alimta Pemetrexed Disodium Eli Lilly 1 P, O 04-Feb-04
N021594 Amiodarone Hydrochloride Amiodarone Hydrochloride International Medication Sys 5 S 04-Feb-04
N021644 Clobex Clobetasol Propionate Galderma Labs 3 S 05-Feb-04
N021166 Estrogel Estradiol Solvay Pharms 3 S 09-Feb-04
N021590 Fazaclo Clozapine Alamo Pharms 3 S 10-Feb-04
N021643 MVI Adult Multi-Vitamins aaiPharma 3 S 18-Feb-04
N021587 Children's Advil Allergy Sinus Ibuprofen; Pseudophedrine Hydrochloride; Chlorpheniramine Maleate Wyeth Cons 3 S 24-Feb-04
N050791 Myfortic Mycophenolic Acid Novartis Pharms 2 S 27-Feb-04
N021571 Iquix Levofloxacin Santen 3 S 01-Mar-04
N021688 Sensipar Cinacalcet Hydrochloride Amgen 1 P, O 08-Mar-04
N021621 Zyrtec Cetirizine Hydrochloride Pfizer 3 S 16-Mar-04
N021211 Follistim AQ Follitropin Beta Organon 3 S 23-Mar-04
N021765 Gonal-F Follitropin Alfa Serono Inc 3 S 25-Mar-04
N021253 Zyprexa IM Olanzapine Eli Lilly 3 S 29-Mar-04
N021144 Ketek Telithromycin Aventis Pharms 1 S 01-Apr-04
N020784 Nasacort HFA Triamcinolone Acetonide Aventis Pharms 3 S 07-Apr-04
N021256 ChiRhoStim Human Secretin Chirhoclin 1 P 09-Apr-04
N021629 Apidra Insulin Glulisine Aventis Pharms 1 S 16-Apr-04
N021264 Apokyn Apomorphine Hydrochloride Bertek 1 P, O 20-Apr-04
N021574 Fortamet Metformin Hydrochloride Andrx 5 S 27-Apr-04
N021640 Vitrase Ovine Hyaluronidase Ista Pharms 1 P 05-May-04
N021504 Lidosite Topical System Lidocaine Hydrochloride; Epinephrine Vyteris 3 S 06-May-04
N021617 Zalkote Valproate Sodium Andrx 3 S 06-May-04*
N021443 Enjuvia Synthetic Conjugated Estrogens, B Duramed 3 S 10-May-04
N021551 Halflytely and Bisacodyl Bowel Prep Kit PEG-3350; Sodium Chloride; Sodium Bicarbonate; Potassium Chloride; Bisacodyl Braintree 3 S 10-May-04
N021433 Flovent HFA Fluticasone Propionate GlaxoSmithKline 3 S 14-May-04
N021618 Tindamax Tinidazole Presutti Labs 1 S 17-May-04
N021671 Depodur Morphine Sulfate Skye Pharma 3 S 18-May-04
N050794 Vidaza Azacitidine Pharmion 1 P, O 19-May-04
N021361 Xifaxan Rifaximin Salix Pharms 1 S 25-May-04
N021494 Axid Nizatidine Reliant Pharma 3 S 25-May-04
N021684 Gonal-F RFF Pen Follitropin Alfa Serono Inc 3 S 25-May-04
N021566 Prevacid IV Lansoprazole Tap Pharm 3 S 27-May-04
N021595 Sanctura Trospium Chloride Indevus 1 S 28-May-04
N021530 Mobic Meloxicam Boehringer Ingelheim 3 S 01-Jun-04
N021516 Istalol Timolol Maleate Senju 3 S 04-Jun-04
N021667 NutreStore L-Glutamine Nutritional Restart 1 S, O 10-Jun-04
N021636 Zegerid Omeprazole Santarus 3 S 15-Jun-04
N021369 Codeprex Codeine Polistirex; Chlorpheniramine Polistirex Celltech Pharms 3 S 21-Jun-04
N021585 Mucinex D Guaifenesin; Pseudoephedrine Hydrochloride Adams 3 S 22-Jun-04
N021512 Loratadine Loratadine Perrigo 3 S 24-Jun-04
N050789 Tobramycin Tobramycin American Pharm 5 S 13-Jul-04
N021612 Luxacor Fenofibrate Cipher 3 S 15-Jul-04*
N021497 Alinia Nitazoxanide Romark 3 P 21-Jul-04
N021687 Vytorin Ezetimibe; Simvastatin MSP Singapore 4 S 23-Jul-04
N021415 Metvix Methyl Aminolevulinate PhotoCure ASA 3 S 27-Jul-04
N021431 Campral Acamprosate Calcium Lipha 1 P 29-Jul-04
N050792 Cefotaxime and Dextrose Duplex Container Cefotaxime Sodium B Braun 5 S 29-Jul-04
N021652 Epzicom Abacavir Sulfate; Lamivudine GlaxoSmithKline 3 S 02-Aug-04
N021752 Truvada Emtricitabine; Tenofovir Disoproxil Fumarate Gilead Sciences 4 P 02-Aug-04
N021427 Cymbalta Duloxetine Hydrochloride Eli Lilly 1 S 03-Aug-04
N021768 Fludeoxyglucose F18 Fludeoxyglucose F18 Weill Medical College 3 S 05-Aug-04
N021749 Pentetate Calcium Trisodium Pentetate Calcium Trisodium Pharma Hameln GmbH 1 P, O 11-Aug-04
N021751 Pentetate Zinc Trisodium Pentetate Zinc Trisodium Pharma Hameln GmbH  1 P, O 11-Aug-04
N021633 Femtrace Estradiol Acetate Warner Chilcott 3 S 20-Aug-04
N021648 Digoxin Digoxin Roxane 7 S 26-Aug-04
N021678 Tequin Gatifloxacin Bristol-Myers Squibb 3 S 27-Aug-04
N021698 Zantac Ranitidine Hydrochloride Pfizer Consumer Healthcare 3 S 31-Aug-04
N021300 Clarinex Desloratadine Schering 3 S 01-Sep-04
N021563 Clarinex Desloratadine Schering 3 P 01-Sep-04
N021712 Fluxid Famotidine Schwarz Pharma 3 S 24-Sep-04
N021044 Palladone Hydromorphone Hydrochloride Purdue Pharma 3 S 24-Sep-04
N021727 Amlexanox Amlexanox Access Pharms 3 S 29-Sep-04
N021735 Terconazole Terconazole Altana 5 S 01-Oct-04
N021322 Luveris Lutropin Alfa Serono Inc 3 S, O 08-Oct-04
N021732 Vantas Histrelin Acetate Valera 3 S 12-Oct-04
N021683 Manoplex Insoluble Prussian Blue Degussa 5 P 14-Oct-04*
N021719 Aricept Donepezil Hydrochloride EISAI Medical 3 S 18-Oct-04
N021720 Aricept Donepezil Hydrochloride EISAI Medical 3 S 18-Oct-04
N021704 Allegra-D 24 Hour Fexofenadine Hydrochloride; Pseudoephedrine Hydrochloride Aventis Pharms 3 S 19-Oct-04
N021721 Levaquin Levoflaxin Ortho McNeil 3 S 21-Oct-04
N050801 Evoclin Clindamycin Phosphate Connetics 3 S 22-Oct-04*
N021468 Fosrenol Lanthanum Carbonate Hydrate Shire Pharm 1 S 26-Oct-04
N021486 Lidocaine Hydrochloride;Epinephrine Lidocaine Hydrochloride; Epinephrine EMPI 4 S 26-Oct-04
N021665 Amphadase Hyaluronidase Amphastar Pharm 1 P 26-Oct-04
N021736 Xamlom Amlodipine Ranbaxy Res 3 S 28-Oct-04*
N021457 Albuterol Sulfate Albuterol Sulfate Ivax Res 3 S 29-Oct-04
N021663 Menopur Menotropins Ferring 3 S 29-Oct-04
N021656 Tricor Fenofibrate Abbott 3 S 05-Nov-04
N021654 Omacor Omega-3-acid Ethyl Esters Ross Prods 1 S 10-Nov-04
N021527 Atrovent HFA Ipratropium Bromide Boehringer Ingelheim 3 S 17-Nov-04
N021743 Tarceva Erlotinib Hydrochloride OSI Pharms 1 P 18-Nov-04
N021518 VESIcare Solifenacin Succinate Yamanouchi 1 S 19-Nov-04
N021357 Multihance Gadobenate Dimeglumine Bracco 1 S 23-Nov-04
N021358 Multihance Multipack Gadobenate Dimeglumine Bracco 3 S 23-Nov-04
N021378 Combunox Ibuprofen; Oxycodone Hydrochloride Forest Labs 4 S 26-Nov-04
N021695 Antara Fenofibrate Reliant Pharms 3 S 30-Nov-04
N050793 Clindesse Clindamycin Phosphate KV Pharm 5 S 30-Nov-04
N021786 Kelacal Pentetate Calcium Trisodium CIS 5 P 01-Dec-04*
N021787 Kelazin Pentetate Zinc Trisodium CIS 5 P 01-Dec-04*
N021713 Abilify Aripiprazole Otsuka America 3 S 10-Dec-04
N021731 Eligard Leuprolide Acetate Atrix 3 S 14-Dec-04
N050804 Zylet Loteprednol Etabonate; Tobramycin Bausch and Lomb 4 S 14-Dec-04