|
Product |
Established
Name |
NDA/Supp
no. |
Nov 1 |
DURAGESIC |
fentanyl transdermal system |
19-813/S-026 |
Nov
6 |
BAYCOL |
cerivastatin
Na tablets |
20-740/S-014 |
VIRAMUNE |
nevirapine
tablets |
20-636/S-014 |
nevirapine
oral suspension |
20-933/S-003 |
Nov 8 |
METHOTREXATE |
methotrexate
Na tablets |
11-719/S-096 |
methotrexate
Na injection |
8-085/S-046 |
Nov 11 |
ZITHROMAX |
azithromycin
for injection |
50-730/S-004 |
azithromycin
oral suspension |
50-710/S-006 |
azithromycin
capsules |
50-670/S-014 |
azithromycin
for injection |
50-733/S-004 |
azithromycin
tablets |
50-693/S-002 |
Nov 12 |
LUXIQ |
betamethasone
valerate foam |
20-934/S-001 |
Nov 13 |
FORTOVASE |
saquinavir
capsules |
20-828/S-008 |
Nov 14 |
INVIRASE |
saquinavir
mesylate capsules |
20-628/S-014 |
SUSTIVA |
efavirenz
capsules |
20-972/S-006 |
Nov 16 |
ZOLOFT |
sertraline HCl
tablets |
19-839/S-038 |
sertraline HCl
oral solution |
20-990/S-006 |
Nov 17 |
LOVENOX |
enoxaparin Na
injection |
20-164/S-036 |
| EFFICACY SUPPLEMENT - For the thromboprophylaxis of deep vein thrombosis, which
may lead to pulmonary embolism, in medical patients who are at risk for thromboembolic
complications due to severely restricted mobility during acute illness. |
LOVENOX |
enoxaparin
Na injection |
20-164/S-037 |
TAMIFLU |
oseltamivir
phosphate capsules |
21-087/S-
002 |
| EFFICACY SUPPLEMENT -For the prophylaxis of
influenza virus in adults and adolescents 13 years and older |
Nov 21 |
EXOSURF NEONATAL |
cetyl
alcohol/colfosceril palm/tyloxapol |
20-044/S-004 |
Nov
28 |
PROZAC |
fluoxetine HCl
capsules |
18-936/S-063 |
SARAFEM |
fluoxetine HCl
capsules |
18-936/S-063 |
ZYBAN |
bupropion HCl
extended-release tablets |
20-711/S-010 |
Nov
29 |
NAVELBINE |
vinorelbine
injection |
20-388/S-012 |
PRIMACOR |
milrinone
lactate injection |
19-436/S-013 |
milrinone
lactate in dextrose 5% injection |
20-343/S-010 |
Nov 30 |
PREVACID |
lansoprazole
delayed-release capsules |
20-406/S-033 |
format.
