Home : FDA Drug Database : Abreva : FDA Information : CDER NDA Approvals for Calendar Year 2000

CDER NDA Approvals for Calendar Year 2000

 CDER NDA Approvals for Calendar Year 2000
 Updated through December 31, 2000

NDA Number Proprietary Name Established Name Applicant Chemical Type Review Classification Approval Date
N020989 Evoxac Cevimeline Hydrochloride SnowBrand 1 S 11-Jan-00
N021014 Trileptal Oxcarbazepine Novartis 1 S 14-Jan-00
N020939 Diltiazem Hydrochloride Diltiazem Hydrochloride Biovail 5 S 28-Jan-00
N021117 Calcium Chloride Calcium Chloride Abbott Labs 3 S 28-Jan-00
N020987 Protonix Pantoprazole Sodium Wyeth Ayerst 1 S 02-Feb-00
N021120 Trinasal Triamcinolone Acetonide Muro Pharms 3 S 04-Feb-00
N021107 Lotronex Alosetron Hydrochloride Glaxo Wellcome 1 P 09-Feb-00
N021084 Skin Exposure Reduction Paste Against Chemical Warfare Agents Perfluoropolymethylisopropyl Ether; Polytetrafluoroethylene U.S. Army 1, 4 P 17-Feb-00
N021114 Betaxon Levobetaxolol Hydrochloride Alcon 2 P 23-Feb-00
N020872 Allegra Fexofenadine Hydrochloride Aventis Pharms 3 S 25-Feb-00
N021015 AndroGel Testosterone Unimed Pharms 3 S 28-Feb-00
N021129 Neurontin Gabapentin Parke Davis 3 S 02-Mar-00
N021088 Viadur Leuprolide Acetate ALZA 3 S 03-Mar-00
N050775 Biaxin XL Clarithromycin Abbott Labs 3 S 03-Mar-00
N021043 Rid Mousse Piperonyl Butoxide; Pyrethrins Soltec Research USA 3 S 07-Mar-00
N021037 Magnevist Gadopentetate Dimeglumine Berlex Labs 3 S 10-Mar-00
N020789 Zonegran Zonisamide Dainippon Pharms 1 S 27-Mar-00
N020971 Septocaine Articaine Hydrochloride; Epinephrine Deproco 1, 4 S 03-Apr-00
N021027 Hectorol    Doxercalciferol Bone Care 3 S 06-Apr-00
N021086 Zyprexa Zydis    Olanzapine Eli Lilly 3 S 06-Apr-00
N021119 Visudyne    Verteporfin QLT Photo 1 P 12-Apr-00
N021143 Trivagizole 3 Clotrimazole Taro Pharms 3 S 12-Apr-00
N020938 Mobic    Meloxicam Boehringer Ingleheim Pharms 1 S 13-Apr-00
N021130 Zyvox   Linezolid Pharmacia & Upjohn 1 P 18-Apr-00
N021131 Zyvox    Linezolid Pharmacia & Upjohn 3 P 18-Apr-00
N021132 Zyvox    Linezolid Pharmacia & Upjohn 3 P 18-Apr-00
N021081 Lantus     Insulin Glargine Aventis Pharms 1 S 20-Apr-00
N020823 Exelon    Rivastigmine Tartrate Novartis Pharms 1 S 21-Apr-00
N021025 Exelon    Rivastigmine Tartrate Novartis Pharms 3 S 21-Apr-00
N021134 Nitrostat  Nitroglycerin Parke Davis 3 S 01-May-00
N021174 Mylotarg   Gemtuzumab Ozogamicin Wyeth Ayerst 1 P, O 17-May-00
N021163 Multi-12 Alpha-tocopherol Acetate; Ascorbic acid; Biotin; Cholecaliferol; Cyanocobalamin; Dexpanthenol; Folic acid; Niacinamide; Pyridoxine Hydrochloride; Riboflavin Phosphate Sodium; Thiamine Hydrochloride; Vitamin A Palmitate Sabex 5 S 18-May-00
N021127 Optivar    Azelastine Hydrochloride Asta Medica 3 S 22-May-00
N020748 Differin    Adapalene Galderma, L.P. 3 S 26-May-00
N021141 Welchol    Colesevelam Hydrochloride GelTex 3 S 26-May-00
N021142 Olux    Clobetasol Propionate Connectics 3 S 26-May-00
N021176 Welchol    Colesevelam Hydrochloride GelTex 1 S 26-May-00
N020986 NovoLog    Insulin Aspart Recombinant Novo Nordisk 1 S 07-Jun-00
N020715 Trelstar Depot  Triptorelin Pamoate Debio Recherche 1 S 15-Jun-00
N021148 Norditropin    Somatropin Recombinant Novo Nordisk 3 S 20-Jun-00
N021056 Targretin    Bexarotene Ligand Pharm 3 P, O 28-Jun-00
N020883 Acova    Argatroban Texas Biotechnology 1 S 30-Jun-00
N021179 Renagel    Sevelamer Hydrochloride Geltex Pharm 3 S 12-Jul-00
N020832 Chloraprep    Chlorhexidine Gluconate; Isopropyl Alcohol Medi Flex Hospital 4 S 14-Jul-00
N020484 Innohep    Tinzaparin Sodium Dupont 1 S 14-Jul-00
N021078 Malarone    Atovaquone; Proguanil Hydrochloride Glaxo Wellcome 4 P 14-Jul-00
N020610 Colazal    Balsalazide Disodium Salix Pham 1 S 18-Jul-00
N020941 Abreva    Docosanol Avanir Pharm 1 S 25-Jul-00
N050779 Cefazolin and Dextrose Cefazolin Sodium B. Braun Medical 5 S 27-Jul-00
N021145 Vaniqa    Eflornithine Hydrochloride WestWood Squibb 3 S 27-Jul-00
N021178 Glucovance    Glyburide; Metformin Hydrochloride Bristol Myers Squibb 3, 4 S 31-Jul-00
N021121 Concerta    Methylphenidate Hydrochloride Alza 3 S 01-Aug-00
N021128 Children's Motrin Ibuprofen; Pseudoephedrine
Hydrochloride		 McNeil Consumer Healthcare 3 S 01-Aug-00
N021214 Rescula Unoprostone Isopropyl Ciba Vision 1 P 03-Aug-00
N021168 Depakote ER   Divalproex Sodium Abbott Labs 3 S 04-Aug-00
N020929 Pulmicort Respules   Budesonide Astra 3 P 08-Aug-00
N021197 Cetrotide    Cetrorelix Acetate Asta Medica 1 S 11-Aug-00
N021167 Vivelle   Estradiol Novartis 3 S 16-Aug-00
N021199 Quixin    Levofloxacin Santen Inc. 3 P 18-Aug-00
N021210 Unithroid    Levothyroxine Sodium Jerome Stevens Pharm 7 S 21-Aug-00
N021077 Advair Diskus   Fluticasone Propionate; Salmeterol Xinafoate Glaxo Wellcome 4 S 24-Aug-00
N021110 Rapamune    Sirolimus Wyeth-Ayerst 3 S 25-Aug-00
N021108 Renova    Tretinoin Johnson & Johnson 3 S 31-Aug-00
N021011 Roxicodone   Oxycodone Hydrochloride Roxane Labs 3 S 31-Aug-00
N021093 Atacand HCT Candesartan Cilexetil Hydrochlorothiazide AstraZeneca 4 S 05-Sep-00
N020911 Qvar    Beclomethasone Dipropionate 3M Pharm 3 S 15-Sep-00
N021226 Kaletra   Lopinavir; Ritonavir Abbott Labs 1, 4 P 15-Sep-00
N021251 Kaletra    Lopinavir; Ritonavir Abbott Labs 3, 4 P 15-Sep-00
N021149 Ovidrel    Choriogonadotropin Alfa Serono Lab 3 S 20-Sep-00
N021097 Visicol   Sodium Phosphate Dibasic Anyhyrdous; Sodium Phosphate Monobasic Monohydrate InKine Pharms 7 S 21-Sep-00
N021248 Trisenox    Arsenic Trioxide Cell Therapeutics 1 P, O 25-Sep-00
N020687 Mifeprex    Mifepristone Population Council 1 P 28-Sep-00
N020833 Flovent Diskus   Fluticasone Propionate Glaxo 3 S 29-Sep-00
N021184 Tazorac    Tazarotene Allergan 3 S 29-Sep-00
N020874 Lunelle    Estradiol Cypionate; Medroxyprogesterone Acetate Pharmacia & Upjohn 4 S 05-Oct-00
N021192 Lescol XL  Fluvastatin Sodium Novartis Pharms 3 S 06-Oct-00
N021216 Neurontin    Gabapentin Parke Davis 3 S 12-Oct-00
N021202 Glucophage XR   Metformin Hydrochloride Bristol Myers 3 S 13-Oct-00
N020958 Pepcid Complete   CalciumCarbonate; Famotidine; Magnesium Hydroxide Merck Labs 4 S 16-Oct-00
N021005 Solaraze    Diclofenac Sodium SkyePharma 3 S 16-Oct-00
N020985 Fluorouracil Fluorouracil Dermik Lab 3 S 27-Oct-00
N021183 Videx EC   Didanosine Bristol-Myers Squibb 3 P 31-Oct-00
N021135 Venofer    Iron Sucrose Luitpold Pharm 3 S 06-Nov-00
N021205 Trizivir    Abacavir Sulfate; Lamivudine; Zidovudine Glaxo Wellcome 3 P 14-Nov-00
N021162 Micardis HCT          Hydrochlorothiazide; Telmisartan Boehringer Pharms 4 S 17-Nov-00
N050782 Clindamycin    Clindamycin Phosphate Clindagel 3 S 27-Nov-00
N050769 Benzamycin Pak    Benzoyl Peroxide; Erythromycin Dermik Labs 3 S 27-Nov-00
N021140 Imodium Advanced   Loperamide Hydrochloride; Simethicone McNeil Cons 3 S 30-Nov-00
N021225 Mirena   Levonorgestrel Berlex Labs 3 S 06-Dec-00
N020010 Lotrisone    Betamethasone Diproprionate; Clotrimazole Schering-Plough 3, 4 S 08-Dec-00
N050777 Protopic   Tacrolimus Fujisawa Healthcare 3 S 08-Dec-00
N021246 Tamiflu   Oseltamivir Phosphate Hoffmann-La Roche 3 P 14-Dec-00
N020873 Angiomax   Bivalirudin The Medicines Co. 1 S 15-Dec-00
N021190 Buspar   Buspirone Hydrochoride Bristol Myers Squibb 3 S 20-Dec-00
N021090 Cyclessa   Desogestrel; Ethinyl Estradiol Organon 3 S 20-Dec-00
N050756 BenzaClin    Benzoyl Peroxide; Clindamycin Dermik Labs 4 S 21-Dec-00
N021204 Starlix Nateglinide Novartis Pharms 1 S 22-Dec-00
N021228 Detrol LA   Tolterodine Tartrate Pharmacia & Upjohn 3 S 22-Dec-00

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 Drugs at FDA Logo links back to Initial Search Page

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