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