CDER NDA Approvals for Calendar Year 2001

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FDA/Center for Drug Evaluation and Research

CDER NDA Approvals for Calendar Year 2001
Updated through December 31, 2001

NDA Number	Proprietary Name	Established Name	Applicant	Chemical Type	Review Classification	Approval Date
N021252	Canasa	Mesalamine	Axcan Scandipharm	5	P	05-Jan-01
N021208	Remeron SolTab	Mirtazapine	Organon	3	S	12-Jan-01
N021227	Cancidas	Caspofungin Acetate	Merck Research Labs	1	P	26-Jan-01
N021261	Monistat 3 Combination Pack	Miconazole Nitrate	Personal Products	4	S	02-Feb-01
N050783	Periostat	Doxycycline Hyclate	Collagenex Pharms	3	S	02-Feb-01
N020825	Geodon	Ziprasidone Hydrochloride	Pfizer	1	S	05-Feb-01
N021231	Zomig ZMT	Zolmitriptan	Astra Zeneca Pharms	3	S	13-Feb-01
N020831	Foradil	Formoterol Fumarate	Novartis	1	S	16-Feb-01
N050781	Arestin	Minocycline Hydrochloride	Orapharma	3	S	16-Feb-01
N021153	Nexium	Esomeprazole Magnesium	Astra Zeneca	2	S	20-Feb-01
N021265	Infuvite Pediatric	Multiple Vitamins	Sabex	5	S	21-Feb-01
N050780	Cefuroxime; Dextrose in Duplex Container	Cefuroxime Sodium; Dextrose	B. Braun	5	S	21-Feb-01
N021235	Prozac Weekly	Fluoxetine Hydrochloride	Eli Lilly	3	S	26-Feb-01
N021169	Reminyl	Galantamine Hydrobromide	Janssen Research	1	S	28-Feb-01
N021082	Tavist Allergy Sinus Headache	Acetaminophen; Clemastine Fumarate; Pseudoephedrine Hydrochloride	Novartis	4	S	01-Mar-01
N021257	Travatan	Travoprost	Alcon	1	P	16-Mar-01
N021262	Alphagan P	Brimonidine Tartrate	Allergan	3	S	16-Mar-01
N021275	Lumigan	Bimatoprost	Allergan	1	P	16-Mar-01
N020950	DuoNeb	Albuterol Sulfate; Ipratropium Bromide	Dey Labs	4	S	21-Mar-01
N020988	Protonix	Pantoprazole Sodium	Wyeth-Ayerst	3	S	22-Mar-01
N021304	Valcyte	Valganciclovir Hydrochloride	Roche	2	P	29-Mar-01
N021160	PhosLo	Calcium Acetate	Braintree Lab	3	S	02-Apr-01
N021259	Metadate CD	Methylphenidate Hydrochloride	Celltech Pharms	3	S	03-Apr-01
N020983	Ventolin HFA	Albuterol Sulfate	GlaxoSmithKline	3	S	19-Apr-01
N020949	AccuNeb	Albuterol Sulfate	Dey	5	S	30-Apr-01
N021281	Prevacid	Lansoprazole	Tap Pharm	3	S	03-May-01
N021001	Axert	Almotriptan Malate	Pharmacia & UpJohn	1	S	07-May-01
N021335	Gleevec	Imatinib Mesylate	Novartis	1	P, O	10-May-01
N021098	Yasmin	Drospirenone; Ethinyl Estradiol	Berlex Labs	1, 4	S	11-May-01
N021285	Trileptal	Oxcarbazepine	Novartis	3	S	25-May-01
N021301	Levoxyl	Levothyroxine Sodium	Jones Pharma	5	S	25-May-01
N021074	Avagard	Alcohol; Chlorhexidine Gluconate	3M	3	S	07-Jun-01
N021224	Reminyl	Galantamine Hydrobromide	Janssen Research	3	S	22-Jun-01
N050755	Augmentin ES-600	Amoxicillin; Clavulanate Potassium	GlaxoSmithKline	3	S	22-Jun-01
N021105	Phenazopyridine Hydrochloride; Sulfamethoxazole; Trimethoprim	Phenazopyridine Hydrochloride; Sulfamethoxazole; Trimethoprim	Able Labs	4	S	26-Jun-01
N021238	Kytril	Granisetron Hydrochloride	Roche	3	S	27-Jun-01
N021288	Trelstar	Triptorelin Pamoate	Pharmacia and Upjohn	3	S	29-Jun-01
N021146	Atropine Sulfate	Atropine Sulfate	Abbott	5	S	09-Jul-01
N021283	Diovan	Valsartan	Novartis	3	S	18-Jul-01
N021064	Definity	Perflutren	Bristol Myers Squibb	1	S	31-Jul-01
N020920	Natrecor	Nesiritide	Scios	1	S	10-Aug-01
N021150	Zyrtec-D 12 Hour	Cetirizine Hydrochloride; Pseudoephedrine Hydrochloride	Pfizer	4	S	10-Aug-01
N021123	Ultracet	Acetaminophen; Tramadol Hydrochloride	RW Johnson	4	S	15-Aug-01
N021223	Zometa	Zoledronic Acid	Novartis	1	P	20-Aug-01
N021222	Spectracef	Cefditoren Pivoxil	Tap	1	S	29-Aug-01
N021203	Tricor	Fenofibrate	Abbott	3	S	04-Sep-01
N021279	Foradil Aerolizer	Formoterol Fumarate	Novartis	3	S	25-Sep-01*
N021324	Entocort EC	Budesonide	AstraZeneca	3	P	02-Oct-01
N021187	NuvaRing	Etonogestrel; Ethinyl Estradiol Vaginal Ring	Organon	1	S	03-Oct-01
N021303	Adderall XR	Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate	Shire Labs	3	S	11-Oct-01
N021317	Bayer Extra Strength Aspirin for Migraine Pain	Aspirin	Bayer	7	S	18-Oct-01
N021356	Viread	Tenofovir Disoproxil Fumarate	Gilead Sciences	1	P	26-Oct-01
N021172	Novolog Mix 70/30	Insulin Aspart; Insulin Aspart Protamine	Novo Nordisk	4	S	01-Nov-01
N021268	Teveten HCT	Eprosartan Mesylate; Hydrochlorothiazide	Unimed	4	S	01-Nov-01
N021006	Frova	Frovatriptan Succinate	Elan Pharms	1	S	08-Nov-01
N021278	Focalin	Dexmethylphenidate Hydrochloride	Celgene	3	S	13-Nov-01
N021341	Bextra	Valdecoxib	Searle Pharms	1	S	16-Nov-01
N021180	Ortho Evra	Ethinyl Estradiol; Norelgestromin	RW Johnson	1, 4	S	20-Nov-01
N021290	Tracleer	Bosentan	Actelion	1	S, O	20-Nov-01
N021319	Avodart	Dutasteride	Glaxo SmithKline	1	S	20-Nov-01
N021337	Invanz	Ertapenem Sodium	Merck	1	S	21-Nov-01
N021277	Avelox	Moxifloxacin Hydrochloride	Bayer	3	S	30-Nov-01
N021345	Arixtra	Fondaparinux Sodium	Fonda BV	1	P	07-Dec-01
N021302	Elidel	Pimecrolimus	Novartis	1	S	13-Dec-01
N021249	Advicor	Lovastatin; Niacin	Kos	4	S	17-Dec-01*
N021165	Clarinex	Desloratadine	Schering Plough	1	S	21-Dec-01

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).

* NDA 21279, Foradil Aerolizer - Chemical Type is a 6 but for reporting purposes original reports are not changed.
* NDA 21249, Advicor was tentatively approved on 16-Nov-01. Advicor was approved on 17-Dec-01.

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

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