Reference Listed Drug Labeling
and Efficacy
Supplements Approved in June 2002
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|
Approval
Date
|
Product Name |
|
|
Active Ingredient(s) |
Dosage Form
|
NDA No
|
Supp No
|
| |
TRIZIVIR |
letter |
label |
abacavir sulfate, lamivudine, zidovudine
|
tablets
|
21-205 |
SLR 004 |
| Jun
4 |
CAFERGOT |
letter |
label |
ergotamine tartrate and caffeine
|
suppositories
|
09-000 |
SLR 022 |
| |
M.V.I.-12 |
letter |
|
multi-vitamins for infusion
|
injection
|
08-809 |
SLR 046 |
| |
PEPCID
injection |
letter |
label |
famotidine
|
injection
|
20-249 |
SE8 011 |
| |
PEPCID
oral susp |
letter |
label |
famotidine
|
oral suspension
|
19-527 |
SE8 024 |
| Jun
6 |
PEPCID
injection |
letter |
label |
famotidine
|
injection
|
19-510 |
SE8 028 |
| |
PEPCID
tablets |
letter |
label |
famotidine
|
tablets
|
19-462 |
SE8 030 |
| |
BIAXIN |
letter |
|
clarithomycin
|
tablets
|
50-662 |
SLR 031 |
| Jun
7 |
LOTRONEX |
letter |
label |
alosetron HCl
|
tablets
|
21-107 |
SE8 005 |
| |
CELEBREX |
letter |
label |
celecoxib
|
capsules
|
20-998 |
SE8 009 |
| |
ACTIQ |
letter |
|
fentanyl citrate
|
oral transmucosal
|
20-747 |
SLR 011 |
| |
RETIN-A |
letter |
label |
treinoin
|
cream
|
19-049 |
SLR 011 |
| Jun 10 |
RETIN-A |
letter |
label |
treinoin
|
liquid
|
16-921 |
SLR 021 |
| |
RETIN-A |
letter |
label |
treinoin
|
cream
|
17-522 |
SLR 022 |
| |
RETIN-A |
letter |
label |
treinoin
|
cream
|
17-579 |
SLR 023 |
| |
RETIN-A |
letter |
label |
treinoin
|
gel
|
17-955 |
SLR 023 |
| Jun
11 |
APHTHASOL |
letter |
label |
amlexanox
|
oral paste
|
20-511 |
SLR 002 |
| |
SARAFEM |
letter |
label |
fluoxetine HCl
|
capsules
|
18-936 |
SE2 067 |
| Jun 12 |
AVELOX |
letter |
label |
moxofloxacin
|
tablets
|
21-085 |
SLR 007 |
| |
NEORAL |
letter |
label |
cyclosporine
|
capsules
|
50-715 |
SLR 014 |
| |
NEORAL |
letter |
label |
cyclosporine
|
oral solution
|
50-716 |
SLR 018 |
| |
NASCOBAL |
letter |
|
cyanocobalamin
|
nasal gel
|
19-722 |
SLR 004 |
| Jun 14 |
ESTROSTEP FE |
letter |
|
norethindrone acetate/ethinyl estradiol
|
tablets
|
20-130 |
SLR 009 |
| |
CEREZYME |
letter |
label |
imiglucerase
|
injection
|
20-367 |
SLR 053 |
| |
COLAZAL |
letter |
|
balsalazide disodium
|
capsules
|
20-610 |
SLR 001 |
| |
MONODOX |
letter |
|
doxycycline monohydrate
|
capsules
|
50-641 |
SLR 010 |
| |
VIBRAMYCIN |
letter |
|
doxycycline hyclate
|
capsules
|
50-007 |
SLR 014 |
| Jun 18 |
VIBRAMYCIN |
letter |
|
doxycycline hyclate
|
injection
|
50-442 |
SLR 015 |
| |
DORYX |
letter |
|
doxycycline hyclate
|
capsules
|
50-582 |
SLR 016 |
| |
VIBRA-TABS |
letter |
|
doxycycline hyclate
|
tablets
|
50-533 |
SLR 030 |
| |
VIBRAMYCIN |
letter |
|
doxycycline calcium
|
syrup
|
50-480 |
SLR 035 |
| |
VIBRAMYCIN |
letter |
|
doxycycline monohydrate
|
oral suspension
|
50-006 |
SLR 074 |
| |
LOTREL |
letter |
|
amlodipine and benazepril HCl
|
capsules
|
20-364 |
SE8 016 |
| |
ISOVUE-370 |
letter |
|
iopamidol
|
injection
|
20-327 |
SLR 002 |
| |
ANGIOMAX |
letter |
|
bivalirudin
|
injection
|
20-873 |
SLR 004 |
| Jun 20 |
WELLBUTRIN SR |
letter |
|
bupropion
|
tablets
|
20-358 |
SLR 018 |
| |
WELLBUTRIN |
letter |
|
bupropion
|
extended-release tablets
|
18-644 |
SLR 023 |
| |
OPHTHETIC |
letter |
label |
proparacaine HCl
|
ophthalmic sol
|
12-583 |
SLR 028 |
| |
SERZONE |
letter |
|
nefazodone HCl
|
tablets
|
20-152 |
SLR 033 |
| |
SKELAXIN |
letter |
|
metaxalone
|
tablets
|
13-217 |
SLR 044 |
| |
ACCUTANE |
letter |
label |
isotretinoin
|
capsules
|
18-662 |
SLR 051 |
| |
CRIXIVAN |
letter |
label |
indinavir
|
capsules
|
20-685 |
SLR 056 |
| Jun 21 |
CENESTIN |
letter |
label |
synthetic conjugated estrogens
|
tablets
|
20-992 |
SE1 016 |
| Jun 24 |
EPIVIR |
letter |
label |
lamivudine
|
tablets
|
20-564 |
SE2 015 |
| |
EPIVIR |
letter |
label |
lamivudine
|
oral solution
|
20-596 |
SE2 016 |
| Jun 26 |
NEUTREXIN |
letter |
label |
trimexate glucoronate
|
injection
|
20-326 |
SLR 013 |
| Jun 28 |
PARAFON FORTE |
letter |
|
chlorzoxazone
|
tablets
|
11-529 |
SLR 048 |
