CDER
Drug and Biologic Approvals for Calendar Year 2005
Updated through
December 31, 2005
All New Drug Application
(NDA) Approvals:
|
NDA
Number |
Proprietary
Name |
Established
Name |
Applicant |
Chemical
Type |
Review
Classification |
Approval
Date |
|
N021660 |
Abraxane |
Paclitaxel
Protein-Bound Particles |
American
BioScience |
5 |
S |
07-Jan-05 |
|
N021726 |
Niravam |
Alprazolam |
Schwarz
Pharma |
5 |
S |
19-Jan-05 |
|
N021841 |
Lamivudine;
Zidovudine; Nevirapine |
Lamivudine;
Zidovudine; Nevirapine |
Pharmacare |
4 |
P |
24-Jan-05* |
|
N021642 |
Nascobal |
Cyanocobalamin |
Nastech
Pharma |
3 |
S |
31-Jan-05 |
|
N021759 |
Eloxatin |
Oxaliplatin |
Sanofi-Synthelabo |
5 |
S |
31-Jan-05 |
|
N021758 |
Vanos |
Fluocinonide |
Medicis
Pharma |
3 |
S |
11-Feb-05 |
|
N020645 |
Ammonul |
Sodium
Benzoate; Sodium Phenylacetate |
Ucyclyd
Pharma |
5 |
P,
O |
17-Feb-05 |
|
N021269 |
Cardura
XL |
Doxazosin
Mesylate |
Pfizer |
3 |
S |
22-Feb-05 |
|
N021764 |
Brimonidine
Tartrate |
Brimonidine
Tartrate |
Alcon |
3 |
S |
28-Feb-05* |
|
N021605 |
Clarinex
D24 |
Desloratadine;
Pseudoephedrine Sulfate |
Schering |
3 |
S |
03-Mar-05 |
|
N021730 |
Xopenex
HFA |
Levalbuterol
Tartrate |
Sepracor |
3 |
S |
11-Mar-05 |
|
N021332 |
Symlin |
Pramlintide
Acetate |
Amylin |
1 |
S |
16-Mar-05 |
|
N021506 |
Mycamine |
Micafungin
Sodium |
|
1 |
P |
16-Mar-05 |
|
N021664 |
Xibrom |
Bromfenac
Sodium |
ISTA
Pharms |
3 |
S |
24-Mar-05 |
|
N021584 |
Depo-SubQ
Provera 104 |
Medroxyprogesterone
Acetate |
Pfizer |
5 |
S |
25-Mar-05 |
|
N021797 |
Baraclude |
Entecavir |
|
1 |
P |
29-Mar-05 |
|
N021798 |
Baraclude |
Entecavir |
|
3 |
P |
29-Mar-05 |
|
N021067 |
Asmanex
Twisthaler |
Mometasone
Furoate |
Schering |
3 |
S |
30-Mar-05 |
|
N021152 |
Cutivate |
Fluticasone
Propionate |
GlaxoSmithKline |
3 |
S |
31-Mar-05 |
|
N021689 |
Nexium
IV |
Esomeprazole
Sodium |
AstraZeneca |
3 |
S |
31-Mar-05 |
|
N021615 |
Razadyne
ER |
Galantamine
Hydrobromide |
Johnson
and Johnson |
3 |
S |
01-Apr-05 |
|
N021762 |
Fosamax Plus
D |
Alendronate
Sodium; Vitamin D3 |
Merck |
4 |
S |
07-Apr-05 |
|
N021737 |
Retisert |
Fluocinolone
Acetonide |
Bausch and
Lomb |
3 |
P,
O |
08-Apr-05 |
|
N021627 |
Namenda |
Memantine
Hydrochloride |
|
3 |
S |
18-Apr-05 |
|
N050796 |
Ceftriaxone
Sodium; Dextrose in Duplex Container |
Ceftriaxone
Sodium; Dextrose |
B
Braun |
5 |
S |
20-Apr-05 |
|
N021669 |
Chlorhexidine
Gluconate Cloth |
Chlorhexidine
Gluconate |
Sage
Prods |
3 |
S |
25-Apr-05 |
|
N021773 |
Byetta |
Exenatide |
Amylin |
1 |
S |
28-Apr-05 |
|
N021693 |
Tramadol
Hydrochloride |
Tramadol
Hydrochloride |
Biovail
Labs |
3 |
S |
05-May-05 |
|
N050795 |
Doryx |