| Reference
Listed Drug Labeling and Efficacy Supplements Approved in October 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. |
| Oct 1 |
THYROLAR-3 |
letter |
label |
liotrix tablets |
16-807 |
SLR 025 |
| Oct 1 |
VUMON |
letter |
label |
teniposide for injection |
20-119 |
SLR 004 |
| Oct 2 |
PAXIL |
letter |
label |
paroxetine HCl tablets |
20-031 |
SE8 035 |
| Oct 2 |
WELLBUTRIN |
letter |
label |
bupropion HCl tablets |
18-644 |
SLR 024 |
| Oct 2 |
WELLBUTRIN SR |
letter |
label |
bupropion HCl extended-release tablets |
20-358 |
SLR 024 |
| Oct 2 |
ZAGAM |
letter |
label |
sparfooxacin tablets |
20-677 |
SLR 004 |
| Oct 2 |
ZIAGEN |
letter |
label |
abacavir sulfate tablets |
20-977 |
SLR 007 |
| Oct 2 |
ZIAGEN |
letter |
label |
abacavir sulfateoral solution |
20-978 |
SLR 008 |
| Oct 3 |
LARIAM |
letter |
label |
mefloquine HCl tablets |
19-591 |
SLR 020 |
| Oct 4 |
PROSTEP |
letter |
label |
nicotine transdermal system |
19-983 |
SLR 017 |
| Oct 7 |
ARIMIDEX |
letter |
label |
anastrozole tablets |
20-541 |
SLR 005 |
| Oct 7 |
LITHOBID |
letter |
label |
lithium carbonate extended-release tablets |
18-027 |
SLR 049 |
| Oct 7 |
ZONEGRAN |
letter |
label |
zonisamide capsules |
20-789 |
SLR 005 |
| Oct 8 |
COMBIVIR |
letter |
label |
lamivudine/zidovudine tablets |
20-857 |
SLR 012 |
| Oct 8 |
EPIVIR |
letter |
label |
lamivudine tablets |
20-564 |
SLR 014 |
| Oct 8 |
EPIVIR |
letter |
label |
lamivudine oral solution |
20-596 |
SLR 015 |
| Oct 8 |
ETHRANE |
letter |
label |
ethrane liquid for inhalation |
17-087 |
SLR 045 |
| Oct 8 |
TRIZIVIR |
letter |
label |
abacavir/lamivudine/zidovudine tablets |
21-205 |
SLR 007 |
| Oct 9 |
AVODART |
letter |
label |
dutasteride capsules |
21-319 |
SE1 001 |
| Oct 9 |
ZOMIG |
letter |
label |
zolmitriptan tablets |
20-768 |
SLR 010 |
| Oct 9 |
ZOMIG-ZMT |
letter |
label |
zolmitriptan orally disintegrating tablets |
21-231 |
SLR 003 |
| Oct 10 |
DARAPRIM |
|
label |
pyrimethamine tablets |
08-578 |
SLR 015 |
| Oct 16 |
VIDEX EC |
letter |
label |
didanosine EC tablets |
21-183 |
SLR 006 |
| Oct 16 |
ZITHROMAX |
letter |
label |
azithromycin single dose pack |
50-693 |
SLR 005 |
| Oct 16 |
ZITHROMAX |
letter |
label |
azithromycin for injection |
50-733 |
SLR 006 |
| Oct 16 |
ZITHROMAX |
letter |
label |
azithromycin tablets |
50-730 |
SLR 007 |
| Oct 16 |
ZITHROMAX |
letter |
label |
azithromycin capsules |
50-670 |
SLR 017 |
| Oct 16 |
ZITHROMAX |
letter |
label |
azithromycin oral suspension |
50-710 |
SLR 007 |
| Oct 16 |
ZITHROMAX TRI-PAK |
letter |
label |
azithromycin tablets |
50-784 |
SLR 002 |
| Oct 17 |
TEQUIN |
letter |
label |
gatifloxacin injection |
21-062 |
SLR 017 |
| Oct 17 |
TEQUIN |
letter |
label |
gatifloxacin tablets |
21-061 |
SLR 016 |
| Oct 18 |
LIPITOR |
letter |
label |
atorvastatin tablets |
20-702 |
SE5 033 |
| Oct 18 |
ZOCOR |
letter |
label |
simvastatin tablets |
19-766 |
SE5 056 |
| Oct 21 |
PRANDIN |
letter |
label |
repaglinide tablets |
20-741 |
SE1 013 |
| Oct 21 |
ZYRTEC |
letter |
label |
cetirizine tablets |
20-346 |
SE5 008 |
| Oct 21 |
ZYRTEC |
letter |
label |
cetirizine syrup |
19-835 |
SE5 015 |
| Oct 22 |
ANDROGEL |
letter |
label |
testosterone gel |
21-015 |
SLR 004 |
| Oct 22 |
EFFEXOR XR |
letter |
label |
venlafaxine HCl extended-release capsules |
20-699 |
SLR 029 |
| Oct 22 |
WELLBUTRIN |
letter |
label |
bupropion HCl tablets |
18-644 |
SLR 026 |
| Oct 22 |
WELLBUTRIN SR |
letter |
label |
bupropion HCl extended-release tablets |
20-358 |
SLR 029 |
| Oct 25 |
BENICAR |
letter |
label |
olmesartan medoxomil tablets |
21-286 |
SLR 001 |
| Oct 28 |
COSMEGEN |
letter |
label |
dactinomycin injection |
50-682 |
SLR 019 |
| Oct 28 |
PROTONIX |
letter |
label |
pantoprazole delayed-release tablets |
20-987 |
SLR 013 |
| Oct 28 |
PROTONIX IV |
letter |
label |
pantoprazole injection |
20-988 |
SLR 012 |
| Oct 29 |
BUMEX |
letter |
label |
bumetanide tablets |
18-225 |
SLR 019 |
| Oct 29 |
BUMEX |
letter |
label |
bumetanide injection |
18-226 |
SLR 025 |
| Oct 29 |
MYKROX |
letter |
label |
metolazone tablets |
19-532 |
SLR 015 |
| Oct 29 |
PRAVACHOL |
letter |
label |
pravastatin tablets |
19-898 |
SE5 052 |
| Oct 29 |
PRECOSE |
letter |
label |
acarbose tablets |
20-482 |
SLR 011 |
| Oct 29 |
ZAROXOLYN |
letter |
label |
metolazone tablets |
17-386 |
SLR 034 |
| Oct 30 |
LEVAQUIN |
letter |
label |
levofloxacin tablets |
20-634 |
SE1 025 |
| Oct 30 |
LEVAQUIN |
letter |
label |
levofloxacin injection |
20-635 |
SE1 022 |
| Oct 31 |
ZINECARD |
letter |
label |
dexrazoxane injection |
20-212 |
SE7 006 |
