| Reference
Listed Drug Labeling and Efficacy Supplements Approved in September 2002 |
| Click
on appropriate hyperlink below to view available source document in PDF
format |
|
Approval
Date
|
Product Name
|
Source
Documents |
Active Ingredient(s)/Dosage
Form
|
Document
ID No. |
|
|
ALDARA |
letter |
label |
imiquimod cream |
20-723 |
SLR 012 |
|
|
CYCLOCORT |
letter |
label |
amcinonide
ointment |
18-498 |
SLR 008 |
|
Sep 3 |
KENALOG IN ORABASE |
letter |
label |
triamcinolone
acetonide dental paste |
12-097 |
SLR 016 |
|
|
REBETOL |
|
label |
ribavirin
capsules |
20-903 |
SLR 023 |
|
|
WESTCORT |
letter |
label |
hydrocortisone
valerate ointment |
18-726 |
SLR 012 |
|
Sep 5 |
ARIMIDEX |
letter |
label |
anastrozole
tablets |
20-541 |
SE1 010 |
|
|
LESCOL |
letter |
label |
fluvastatin
Na capsules |
20-261 |
SLR 032 |
|
Sep 6 |
LESCOL XL |
letter |
label |
fluvastatin
Na extended-release tablets |
21-192 |
SLR 004 |
|
|
PURINETHOL |
letter |
|
mercaptopurine
tablets |
09-053 |
SLR 021 |
|
Sep 8 |
NICOTROL |
letter |
|
nicotine
inhalation system |
20-714 |
SLR 010 |
|
|
NICOTROL NS |
letter |
|
nicotine
nasal spray |
20-385 |
SLR 005 |
|
Sep 9 |
VALTREX |
letter |
|
valacyclovir
HCl tablets |
20-550 |
SE1 016 |
|
Sep 11 |
ALTOCOR |
letter |
label |
lovastatin
extended-release tablets |
21-316 |
SE1 001 |
|
|
SPORANOX |
letter |
label |
itraconazole
oral solution |
20-657 |
SLR 007 |
|
Sep 12 |
HIVID |
letter |
label |
zalcitabine
tablets |
20-199 |
SLR 016 |
|
Sep 13 |
ATACAND |
letter |
label |
candesartan
cilexetil tablets |
20-838 |
SE4 015 |
|
Sep 16 |
COLYTE |
letter |
|
PEG
and electrolytes) oral solution |
18-983 |
SLR 035 |
|
|
FOSAMAX |
letter |
label |
alendronate
sodium tablets |
20-560 |
SLR 028 |
|
Sep 17 |
AVAPRO |
letter |
label |
irbesartan
tablets |
20-757 |
SE1 021 |
|
|
COZAAR |
letter |
label |
losartan
potassium tablets |
20-386 |
SE1 028 |
|
Sep 18 |
ZOLOFT |
letter |
|
sertraline
HCl tablets |
19-839 |
SLR 043 |
|
|
ZOLOFT |
letter |
|
sertraline
HCl oral concentrate |
20-990 |
SLR 009 |
|
Sep 19 |
CRIXIVAN |
letter |
label |
indinavir
sulfate capsules |
20-685 |
SLR 055 |
|
|
GOLYTELY |
letter |
|
PEG-3350/electrolytes
for oral solution |
19-011 |
SLR 015 |
|
|
VIAGRA |
letter |
label |
sildenafil
citrate tablets |
20-895 |
SLR 015 |
|
|
CANCIDAS |
letter |
label |
caspofungin
acetate injection |
21-227 |
SE1 001 |
|
|
MEVACOR |
letter |
label |
lovastatin
tablets |
19-643 |
SLR 071 |
|
|
NEXIUM |
letter |
|
esomeprazole
Mg delayed-release capsules |
21-153 |
SLR 005 |
|
Sep 20 |
SUSTIVA |
letter |
|
efavirenz
tablets |
20-972 |
SLR 017 |
|
|
SUSTIVA |
letter |
|
efavirenz
capsules |
21-360 |
SLR 001 |
|
|
ZOLOFT |
letter |
|
sertraline
HCl tablets |
19-839 |
SE8 036 |
|
|
ZOLOFT |
letter |
|
sertraline
HCl oral concentrate |
20-990 |
SE8 004 |
|
Sep 23 |
ACIPHEX |
letter |
|
rabeprazole
Na delayed-release tablets |
20-973 |
SLR 014 |
|
|
ADRIAMYCIN PFS |
letter |
label |
doxorubicin
HCl injection |
50-629 |
SLR 010 |
|
Sep 25 |
ADRIAMYCIN RDF |
letter |
label |
doxorubicin
HCl for injection |
50-467 |
SLR 067 |
|
|
VIDEX |
letter |
label |
didanosine
tablets |
20-155 |
SLR 030 |
|
|
VIDEX |
letter |
label |
didanosine
for oral solution |
20-154 |
SLR 041 |
|
Sep 27 |
PROTOPAM |
letter |
label |
pralidoxime
Cl for injection, |
14-134 |
SLR 024 |
|
|
GLUCOVANCE |
letter |
label |
glyburide/metformin
HCl tablets |
21-178 |
SE1 004 |
|
Sep 30 |
HYPAQUE |
letter |
|
diatrizoate
meglumine |
16-403 |
SLR 071 |
|
|
PROHANCE |
letter |
|
gadoteridol
injection |
20-131 |
SLR 016 |
|
|
REMERON |
letter |
|
mirtazapine
tablets |
20-415 |
SLR 015 |
