NDA Number |
Proprietary Name |
Established
Name |
Applicant |
Chemical
Type |
Review
Classification |
Approval
Date |
N021858 |
Boniva |
ibandronate sodium |
Hoffmann-La
Roche |
3 |
S |
06-Jan-2006 |
N021852 |
Taclonex |
calcipotriene; betamethasone dipropionate |
LEO Pharma |
3 |
S |
09-Jan-2006 |
N021612 |
Lipofen |
fenofibrate |
Cipher |
3 |
S |
11-Jan-2006 |
N021812 |
Men's
Rogaine |
minoxidil |
Pharmacia and
Upjohn |
3 |
S |
20-Jan-2006 |
N021938 |
Sutent |
sunitinib malate |
Pfizer |
1 |
P |
26-Jan-2006 |
N021247 |
Aerospan |
flunisolide HFA |
Forest
Labs |
3 |
S |
27-Jan-2006 |
N021526 |
Ranexa |
ranolazine |
CV
Therapeutics |
1 |
S |
27-Jan-2006 |
N021868 |
Exubera |
insulin [rDNA Origin] |
Pfizer |
3 |
S |
27-Jan-2006 |
N021908 |
Amitiza |
lubiprostone |
Sucampo |
1 |
S |
31-Jan-2006 |
N021313 |
Clarinex-D 12
Hour |
desloratadine; pseudoephedrine sulfate |
Schering |
5 |
S |
01-Feb-2006 |
N021026 |
Vusion |
miconazole nitrate |
Barrier
Therapeutics |
3 |
S |
16-Feb-2006 |
N021920 |
naproxen
sodium |
naproxen
sodium |
Banner Pharmacaps |
3 |
S |
17-Feb-2006 |
N021871 |
Loestrin 24 Fe |
norethindrone acetate; ethinyl estradiol; ferrous fumarate |
Warner Chilcott |
3 |
S |
17-Feb-2006 |
N021632 |
Eraxis |
anidulafungin |
Vicuron |
1 |
S |
17-Feb-2006 |
N021849 |
Zegerid |
omeprazole; sodium
bicarbonate |
Santarus |
4 |
S |
27-Feb-2006 |
N021336 |
Emsam |
selegiline hydrochloride |
Somerset
Pharms |
3 |
S |
27-Feb-2006 |
N021676 |
YAZ |
drospirenone; ethinyl estradiol |
Berlex |
2 |
S |
16-Mar-2006 |
N021892 |
OsmoPrep |
sodium
phosphate monobasic monohydrate; sodium phosphate
dibasic anhydrous |
Salix |
3 |
S |
16-Mar-2006 |
N021850 |
Zegerid with Magnesium
Hydroxide |
magnesium hydroxide; omeprazole; sodium
bicarbonate |
Santarus |
3,4 |
S |
24-Mar-2006 |
N021980 |
Fluorescite |
fluorescein |
Alcon
Research |
5 |
P |
28-Mar-2006 |
N021483 |
Geodon |
ziprasidone hydrochloride |
Pfizer |
3 |
S |
29-Mar-2006 |
N022010 |
Septocaine |
articaine hydrochloride;
epinephrine |
Deproco |
5 |
S |
30-Mar-2006 |
N021514 |
Daytrana |
methylphenidate |
Noven Pharms |
2,3 |
S |
06-Apr-2006 |
N021897 |
Vivitrol |
naltrexone |
Alkermes |
3 |
P |
13-Apr-2006 |
N021903 |
