| Reference
Listed Drug Labeling and Efficacy Supplements Approved in August 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 Number |
|
Aug 1 |
DARVON
|
letter |
|
propoxyphene HCL capsule |
10-997 |
SLR 043 |
|
DARVON Cpd
|
letter |
|
propoxyphene HCL/aspirin/caffeine
capsule |
10-996 |
SLR 061 |
|
DARVON-N
|
letter |
|
propoxyphene napsylate tablet |
16-862 |
SLR 033 |
| Aug 2 |
ALTACE
|
letter |
|
ramipril capsules |
19-901 |
SLR 034 |
|
MALARONE
|
letter |
label |
atovaquone/proguanil hydrochloride tablets |
21-078 |
SE8 003 |
| Aug 5 |
ESKALITH CR
|
letter |
|
lithium carbonate tablets |
18-152 |
SLR 017 |
|
VIDEX EC
|
letter |
label |
didanosine delayed-release capsules |
21-183 |
SLR 004 |
| Aug 7 |
DIFLUCAN
|
letter |
label |
fluconazole tablets |
19-949 |
SLR 033 |
|
DIFLUCAN
|
letter |
label |
fluconazole oral powder |
20-090 |
SLR 015 |
|
MONISTAT 3
|
letter |
|
miconazole nitrate vaginal |
20-827 |
SLR 006 |
| Aug 8 |
DDAVP
|
letter |
|
desmopressin acetate injection |
18-938 |
SLR 017 |
| Aug 9 |
ANDRODERM
|
letter |
|
testosterone transdermal system |
20-489 |
SLR 010 |
|
COMBIVIR
|
letter |
|
lamivudine/zidovudine tablets |
20-857 |
SLR 010 |
|
NICORETTE
|
letter |
|
nicotine polacrilex gum |
18-612 |
SLR 031 |
|
NICORETTE
|
letter |
|
nicotine polacrilex gum |
20-066 |
SLR 013 |
| Aug 12 |
BENTYL
|
letter |
|
dicyclomine HCl injection |
08-370 |
SLR 030 |
| Aug 13 |
NICODERM CQ
|
letter |
|
nicotine transdermal system |
20-165 |
SLR 020 |
|
TRIZIVIR
|
letter |
label |
abacavir sulfate/lamivudine/zidovudine
tablets |
21-205 |
SLR 006 |
| Aug 14 |
ACTIGALL
|
letter |
|
ursodiol capsules |
19-594 |
SLR 021 |
|
DIOVAN
|
letter |
label |
valsarten capsules |
21-283 |
SE1 001 |
|
HIVID
|
letter |
label |
zalcitabine tablets |
20-199 |
SLR 015 |
|
ZIAGEN
|
letter |
label |
abacavir sulfate tablets |
20-977 |
SLR 008 |
|
ZIAGEN
|
letter |
label |
abacavir sulfate oral solution |
20-978 |
SLR 010 |
| Aug 15 |
NEURONTIN
|
letter |
|
gabapentin capsules |
20-235 |
SE8 023 |
|
NEURONTIN
|
letter |
|
gabapentin tablets |
20-882 |
SE8 009 |
|
NEURONTIN
|
letter |
|
gabapentin oral solution |
21-129 |
SE8 010 |
| Aug 16 |
KYTRIL
|
letter |
label |
granisetron HCl injection |
20-239 |
SE1 008 |
| Aug 20 |
LEUSTATIN
|
letter |
|
cladribine injection |
20-229 |
SLR 007 |
| Aug 21 |
ADVAIR DISKUS
|
letter |
|
fluticasone propionate/salmeterol inh |
21-077 |
SLR 008 |
|
MAXIPIME
|
letter |
|
cefepime HCl injection |
50-679 |
SLR 009 |
|
SPECTRACEF
|
letter |
label |
cefditoren pivoxil tablets |
21-222 |
SE1 001 |
|
STIMATE
|
letter |
|
desmopressin acetate nasal spray |
20-355 |
SLR 004 |
| Aug 22 |
LEUSTATIN
|
letter |
|
cladribine injection |
20-229 |
SLR 021 |
| Aug 23 |
VISINE
L.R.
|
letter |
|
oxymetazoline HCl ophthalmic solution |
19-407 |
SLR 010 |
| Aug 26 |
ANTURANE
|
letter |
|
sulfinpyrazone |
11-556 |
SLR 053 |
|
FIORINAL #3
|
letter |
|
butalbital, aspirin, caffeine, and
codeine phosphate capsules |
19-429 |
SLR 006 |
|
LUMIGAN
|
letter |
label |
bimatoprost ophthalmic solution |
21-275 |
SLR 006 |
|
PROLOPRIM
|
letter |
label |
trimethoprim tablets |
17-943 |
SLR 016 |
| Aug 27 |
MEGACE
|
letter |
|
megestrol acetate tablets |
16-979 |
SLR 051 |
| Aug 29 |
COPAXONE
|
letter |
|
glatiramer acetate injection, |
20-622 |
SLR 026 |
|
LEXAPRO
|
letter |
|
escitalopram oxalate tablets |
21-323 |
SE8 001 |
|
MONOPRIL
|
letter |
|
fosinopril Na tablets |
19-915 |
SLR 032 |
|
PERMAX
|
letter |
|
pergolide mesylate tablets |
19-385 |
SLR 028 |
|
TAXOL
|
letter |
|
paclitaxel injection |
20-262 |
SLR 035 |
| Aug 30 |
NOLVADEX
|
letter |
label |
tamoxifen tablets |
17-970 |
SLR 050 |
|
PREVACID
|
letter |
label |
lansoprazole |
20-406 |
SLR 052 |
