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