| Reference
Listed Drug Labeling and Efficacy Supplements Approved in July 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. |
| Jul 2 |
FORTOVASE
|
letter |
label |
saquinavir capsule
|
20-828 |
SLR 010 |
| |
INVIRASE
|
letter |
label |
saquinavir mesylate capsule
|
20-628 |
SLR
016 |
| Jul
3 |
HIVID
|
letter |
label |
zalcitabine tablet
|
20-199 |
SLR
014 |
| Jul
5 |
CLOZARIL
|
letter |
|
clozapine tablet
|
19-758 |
SLR
048 |
| |
CORTIFOAM
|
letter |
label |
hydrocortisone acetate rectal aerosol
|
17-351 |
SLR 027 |
| |
DEFINITY
|
letter |
|
perflutren injection
|
21-064 |
SLR 002 |
| Jul 8 |
ISOVUE
|
letter |
|
iopamidol injection
|
18-735 |
SLR 043 |
| |
OMNISCAN
|
letter |
|
gadodiamide injection
|
20-123 |
SLR 018 |
| |
TESLASCAN
|
letter |
|
mangafodipir trisodium injection
|
20-652 |
SLR
003 |
|
LONITEN
|
letter |
label |
minoxidil tablet
|
18-154 |
SLR 023 |
| Jul 9 |
M.V.I. PEDIATRIC
|
letter |
label |
multi-vitamins injection
|
18-920 |
SLR 024 |
| |
TAXOTERE
|
letter |
|
docetaxel injection
|
20-449 |
SLR
017 |
| Jul
11 |
GLUCAGEN
|
letter |
|
glucagon (rDNA origin) injection
|
20-918 |
SLR
003 |
|
ACTOS
|
letter |
label |
pioglitazone tablet
|
21-073 |
SE8 010 |
| |
AREDIA
|
letter |
|
pamidronate disodium injection
|
20-036 |
SE8 026 |
| Jul 12 |
HABITROL
|
letter |
label |
nicotine transdermal system
|
20-076 |
SLR 020 |
| |
PRAVACHOL
|
letter |
label |
pravastatin Na tablets
|
19-898 |
SLR 050 |
| |
PRILOSEC
|
letter |
label |
omeprazole delayed-release capsule
|
19-810 |
SE5
074 |
|
CLEOCIN T
|
letter |
label |
clindamycin phophate topical solution
|
50-600 |
SLR 002 |
| Jul 14 |
CLEOCIN T
|
letter |
label |
clindamycin phophate gel
|
50-615 |
SLR 003 |
| |
CLEOCIN T
|
letter |
label |
clindamycin phophate lotion
|
50-537 |
SLR 013 |
| |
RENOVA
|
letter |
label |
tretinoin cream
|
21-108 |
SLR
001 |
| Jul
15 |
HABITROL
|
letter |
label |
nicotine transdermal system
|
20-076 |
SLR
021 |
|
ELOCON
|
letter |
label |
mometasone furoate cream
|
19-625 |
SE5 013 |
| |
ELOCON
|
letter |
label |
mometasone furoate lotion
|
19-543 |
SE5 013 |
| |
ELOCON
|
letter |
label |
mometasone furoate ointment
|
19-796 |
SE5 015 |
| Jul 17 |
LEVOXYL
|
letter |
|
levothyroxine Na tablets
|
21-301 |
SLR 002 |
| |
NASONEX
|
letter |
label |
mometasone furoate nasal spray
|
20-762 |
SE5 011 |
| |
SPORANOX
|
letter |
label |
itraconazole injection
|
20-966 |
SLR 006 |
| |
SPORANOX
|
letter |
label |
itraconazole oral solution
|
20-657 |
SLR 008 |
| |
SPORANOX
|
letter |
label |
itraconazole capsules
|
20-083 |
SLR 028 |
| |
ZYLOPRIM
|
letter |
|
allopurinol tablets
|
16-084 |
SLR
041 |
| Jul
18 |
MANDOL
|
letter |
|
cefamandole nafatate injection
|
50-504 |
SLR
059 |
|
ACCUPRIL
|
letter |
|
quinaprilHCl tablets
|
19-885 |
SLR 019 |
| |
ZITHROMAX
|
letter |
|
azithromycin single dose
|
50-693 |
SLR 007 |
| Jul 22 |
ZITHROMAX
|
letter |
|
azithromycin tablet
|
50-730 |
SLR 010 |
| |
ZITHROMAX
|
letter |
|
azithromycin injection
|
50-733 |
SLR 010 |
| |
ZITHROMAX
|
letter |
|
azithromycin capsule
|
50-670 |
SLR 019 |
| |
ZITHROMAX
|
letter |
|
azithromycin oral susp
|
50-710 |
SLR
014 |
| Jul 23 |
DOBUTREX
|
letter |
|
dobutamine injectioin
|
17-820 |
SLR 037 |
| |
NICOTROL
|
letter |
|
nicotine transdermal system
|
20-536 |
SLR
010 |
|
AGGRASTAT
|
letter |
|
tirofiban injection
|
20-913 |
SLR 008 |
| |
AGGRASTAT
|
letter |
|
tirofiban injection
|
20-912 |
SLR 009 |
| Jul 24 |
CEFTIN
|
letter |
|
cefuroxime axetil tablets
|
50-605 |
SLR 037 |
| |
OMNICEF
|
letter |
|
cefdinir capsules
|
50-739 |
SLR 006 |
| |
SANDOSTATIN
|
letter |
|
octreotide acetate injection
|
19-667 |
SLR
032 |
| Jul
25 |
FOSAMAX
|
letter |
label |
alendronate Na tablets
|
20-560 |
SLR
031 |
|
PROZAC
|
letter |
label |
fluoxetine HCl tablets
|
20-974 |
SE8 001 |
| Jul 29 |
PROZAC
|
letter |
label |
fluoxetine HCl oral solution
|
20-101 |
SE8 027 |
| |
PROZAC
|
letter |
label |
fluoxetine HCl capsules
|
18-936 |
SE1
061 |
| Jul 30 |
AZULFIDINE
|
letter |
|
sulfasalazine tablets
|
07-073 |
SLR 120 |
| |
TAXOTERE
|
letter |
label |
docetaxel injection
|
20-449 |
SLR
019 |
|
ALEVE COLD & SINUS
|
letter |
|
naproxen Na/pseudoephedrine HCl ER tablets
|
21-076 |
SLR 007 |
| Jul 31 |
MIGRANAL
|
letter |
label |
dihydroergotamine nasal spray
|
20-148 |
SLR 008 |
| |
PREVACID
|
letter |
label |
lansoprazole delayed-release capsule
|
20-406 |
SE5 047 |
