CDER NDA Approvals for Calendar Year 2003

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FDA/Center for Drug Evaluation and Research

CDER NDA Approvals for Calendar Year 2003
Updated through December 31, 2003

NDA Number	Proprietary Name	Established Name	Applicant	Chemical Type	Review Classification	Approval Date
N021434	Xanax XR	Alprazolam	Pharmacia and Upjohn FR	3	S	17-Jan-03
N021305	Sodium Iodide I-131	Sodium Iodide I-131	DraxImage	3, 5	S	24-Jan-03
N020414	Pyridostigmine Bromide	Pyridostigmine Bromide	US Army	3	P	05-Feb-03
N021392	Cardizem LA	Diltiazem Hydrochloride	Biovail	3	S	06-Feb-03
N021488	Eligard	Leuprolide Acetate	Atrix	3	S	13-Feb-03
N021351	Oxytrol	Oxybutynin	Watson Labs (Utah)	3	S	26-Feb-03
N021159	Loprox	Ciclopirox	Medicis	3	S	28-Feb-03
N021438	InnoPran XL	Propranolol Hydrochloride	Reliant Pharms	5	S	12-Mar-03
N021481	Fuzeon	Enfuvirtide	Roche	1	P	13-Mar-03
N021367	Femring	Estradiol Acetate	Galen Ltd	2	S	20-Mar-03
N021106	Somavert	Pegvisomant	Pharmacia and Upjohn	1	P, O	25-Mar-03
N021549	Emend	Aprepitant	Merck	1	P	26-Mar-03
N021493	Zymar	Gatifloxacin	Allergan	3	S	28-Mar-03
N021444	Risperdal	Risperidone	Johnson & Johnson	3	S	02-Apr-03
N021158	Factive	Gemifloxacin Mesylate	LG Life	1	S	04-Apr-03
N021271	Iprivask	Desirudin	Aventis Pharms	2	S	04-Apr-03
N021475	Methylin	Methylphenidate Hydrochloride	Mallinckrodt	3	S	15-Apr-03
N021598	Vigamox	Moxifloxacin Hydrochloride	Alcon	3	S	15-Apr-03
N021588	Gleevec	Imatinib Mesylate	Novartis	3	P	18-Apr-03
N021503	Viracept	Nelfinavir Mesylate	Agouron	3	S	30-Apr-03
N021399	Iressa	Gefitinib	AstraZeneca	1	P	05-May-03
N021602	Velcade	Bortezomib	Millennium Pharms	1	P, O	13-May-03
N021455	Boniva	Ibandronate Sodium	Roche	1	S	16-May-03
N021496	Duocaine	Bupivacaine Hydrochloride; Lidocaine Hydrochloride	Amphastar Pharms	4	S	23-May-03
N020800	Twinject	Epinephrine	Hollister-Stier Labs	3	S	30-May-03
N021528	Acular LS	Ketorolac Tromethamine	Allergan	3	S	30-May-03
N021396	Prempro; Premphase	Conjugated Estrogens; Medroxyprogesterone Acetate	Wyeth Pharms	3	S	04-Jun-03
N021532	Benicar HCT	Olmesartan Medoxomil; Hydrochlorothiazide	Sankyo	4	S	05-Jun-03
N021137	Levolet	Levothyroxine Sodium	Vintage Pharms	5	S	06-Jun-03
N021485	Stalevo	Carbidopa; Levodopa; Entacapone	Orion Pharma	4	S	11-Jun-03
N021287	Uroxatral	Alfuzosin Hydrochloride	Sanofi Syn Res	1	S	12-Jun-03
N021559	Infuvite Adult	Multiple Vitamins	Sabex	5	S	16-Jun-03
N021543	Striant	Testosterone	Columbia Labs	3	S	19-Jun-03
N021229	Prilosec	Omeprazole Magnesium	AstraZeneca	2, 3	S	20-Jun-03
N021567	Reyataz	Atazanavir Sulfate	Bristol Myers Squibb	1	P	20-Jun-03
N021387	Pravigard PAC	Aspirin; Pravastatin Sodium	Bristol Myers Squibb	4	S	24-Jun-03
N021500	Emtriva	Emtricitabine	Gilead	1	S	02-Jul-03
N020452	Paraplatin	Carboplatin	Bristol Myers Squibb	3	S	14-Jul-03
N021505	Keppra	Levetiracetam	UCB	3	S	15-Jul-03
N021537	Ciprodex	Ciprofloxacin; Dexamethasone	Alcon	3	S	18-Jul-03
N021535	Clobex	Clobetasol Propionate	Galderma Labs LP	3	S	24-Jul-03
N021372	Aloxi	Palonosetron Hydrochloride	Helsinn Hlthcare	1	S	25-Jul-03
N021546	Rebetol	Ribavirin	Schering	3	P, O	29-Jul-03
N021348	Zavesca	Miglustat	Actelion Pharms	1	S, O	31-Jul-03
N021366	Crestor	Rosuvastatin Calcium	AstraZeneca	1	S	12-Aug-03
N021400	Levitra	Vardenafil Hydrochloride	Bayer Pharms	1	S	19-Aug-03
N021515	Wellbutrin XL	Bupropion Hydrochloride	SmithKlineBeecham	3	S	28-Aug-03
N021416	Rythmol SR	Propafenone Hydrochloride	Abbott	3	S	04-Sep-03
N021544	Seasonale	Ethinyl Estradiol; Levonorgesterol	Barr	3	S	05-Sep-03
N021591	Riomet	Metformin Hydrochloride	Ranbaxy	3	S	11-Sep-03
N021572	Cubicin	Daptomycin	Cubist	1	P	12-Sep-03
N021575	Fosamax	Alendronate Sodium	Merck	3	S	17-Sep-03
N021450	Zomig	Zolmitriptan	AstraZeneca	3	S	30-Sep-03
N021626	Radiogardase	Prussian Blue	Heyl Chemisch- pharmazeutische Fabrik GmbH	1	P, O	02-Oct-03
N021371	Estrasorb	Estradiol	Novavax	3	S	09-Oct-03
N021489	ProHance	Gadoteridol	Bracco	3	S	09-Oct-03
N021487	Namenda	Memantine Hydrochloride	Forest Labs	1	S	16-Oct-03
N021565	Elestat	Epinastine Hydrochloride	Allergan	1	S	16-Oct-03
N021548	Lexiva	Fosamprenavir Calcium	GlaxoSmithKline	2	S	20-Oct-03
N021346	Risperdal Consta	Risperidone	Johnson and Johnson	3	S	29-Oct-03
N021589	Kemstro	Baclofen	Schwarz Pharma	3	S	30-Oct-03
N021435	Amvaz	Amlodipine Maleate	Dr Reddys Labs Inc	2	S	31-Oct-03
N021490	Ovcon 35	Ethinyl Estradiol; Norethindrone	Warner Chilcott	3	S	14-Nov-03
N021507	Prevacid;Naprapac	Lansoprozole; Naproxen	Tap Pharm	4	S	14-Nov-03
N021258	Climara Pro	Estradiol; Levonorgestrel	Berlex Labs	4	S	21-Nov-03
N021368	Cialis	Tadalafil	Lilly Icos	1	S	21-Nov-03
N021320	Plenaxis	Abarelix	Praecis	1	P	25-Nov-03
N021385	Ertaczo	Sertaconazole Nitrate	Mylan Pharms	1	S	10-Dec-03
N021388	Sterile Talc Powder	Sterile Talc Powder	Bryan Corp	3	P, O	15-Dec-03
N021451	Oraqix	Lidocaine; Prilocaine	Dentsply Pharms	4	S	19-Dec-03
N021630	Vfend	Voriconazole	Pfizer Inc	3	S	19-Dec-03
N021520	Symbyax	Olanzapine; Fluoxetine Hydrochloride	Eli Lilly	4	P	24-Dec-03

Chemical Type:
1 -   New molecular entity
2 -   New ester, new salt, or other noncovalent derivative
3 -   New formulation
4 -   New combination
5 -   New manufacturer
7 -   Drug already marketed, but without an approved NDA

Review Classification:
P - Priority Review - Significant improvement compared to marketed products, in the treatment, diagnosis, or prevention of a disease.
S - Standard Review - Products that do not qualify for priority review.
O - Orphan Designation - Pursuant to Section 526 of the Orphan Drug Act (Public Law 97-414 as amended).

To access approval letters, labels, and review packages, go to

Date created: March 5, 2004; updated January 19, 2006