Reference Listed Drug Labeling
Approved in June 2000
Some of the product names
below contain links to the approved labeling or the supplemental approval letter
describing the specific changes. Click on the product name to view the approved
labeling changes in Adobe Acrobat  format.
Tradename |
Active Ingredient |
Dosage
Form |
NDA # |
Supp# |
June |
| IMITREX
|
sumatriptan |
nasal solution |
20-626 |
002 |
1 |
| LUVOX
|
fluvoxamine maleate |
tablet |
20-243 |
020 |
1 |
| REGLAN
|
metoclopramide HCl |
injection |
17-862 |
040 |
1 |
| REGLAN
|
metoclopramide |
syrup |
18-821 |
016 |
1 |
| REGLAN
|
metoclopramide |
tablet |
17-854 |
037 |
1 |
| SERZONE
|
nefazodone HCl |
tablet |
20-152 |
023 |
1 |
| RHINOCORT
|
budesonide |
nasal inhaler |
20-233 |
009 |
2 |
| ORTHO-NOVUM
1/50 |
norethindrone/mestranol |
tablet |
16-709 |
126 |
5 |
| ORTHO
CYCLEN-21 |
ethinyl
estradiol/norgestimate |
tablet |
19-653 |
025 |
5 |
| ORTHO
TRI-CYCLEN |
ethinyl
estradiol/norgestimate |
tablet |
19-697 |
022 |
5 |
| ORTHO-NOVUM
7/7/7 |
norethindrone/ethinyl
estradiol |
tablet |
18-985 |
035 |
6 |
| UREAPHIL
|
ureaphil |
for injection |
12-154 |
024 |
6 |
| ANDROGEL
|
testosterone gel |
gel |
21-015 |
001 |
7 |
| NAVELBINE
|
vinorelbine tartrate |
injection |
20-388 |
008 |
8 |
| AQUASOL
A |
vitamin a |
for injection |
6-823 |
014 |
9 |
| CHROMIC
CHLORIDE |
chromic chloride |
injection |
18-961 |
009 |
9 |
| EFFEXOR
XR |
venlafaxine HCl |
ER capsule |
20-699 |
012 |
12 |
| ISMO
|
isosorbide mononitrate |
tablet |
19-091 |
008 |
13 |
| FOSCAVIR
|
foscarnet sodium |
injection |
20-068 |
014 |
13 |
| ATACAND
|
candesartan cilexetil |
tablet |
20-838 |
008 |
14 |
| DOBUTAMINE
HCl IN DEXTROSE |
dobutamine HCl |
for injection |
20-255 |
006 |
14 |
| TICLID
|
ticlopidine HCl |
tablet |
19-979 |
019 |
14 |
| CYTOXAN
|
cyclophosphamide |
tablet |
12-141 |
083 |
15 |
| LYOPHILIZED
CYTOXAN |
cyclophosphamide |
for injection |
12-142 |
101 |
15 |
| SODIUM
ACETATE IN PLASTIC |
sodium acetate |
injection |
18-893 |
013 |
15 |
| DEPACON
|
valproic acid |
injection |
20-593 |
002 |
19 |
| DEPAKENE
|
valproic acid |
capsule |
18-081 |
032 |
19 |
| DEPAKENE
|
valproic acid |
syrup |
18-082 |
023 |
19 |
| DEPAKOTE
|
divalproex sodium |
DR tablet |
18-723 |
028 |
19 |
| DEPAKOTE
|
divalproex sodium |
capsule |
19-680 |
014 |
19 |
| MELLARIL
|
thioridazine HCl |
tablet |
11-808 |
175 |
19 |
| MELLARIL-S
|
thioridazine |
oral suspension |
17-923 |
048 |
19 |
| PREVACID
|
lansoprazole |
DR capsule |
20-406 |
034 |
20 |
| CYTOTEC
|
misoprostol |
tablet |
19-268 |
031 |
22 |
| GEMZAR
|
gemcitabine HCl |
for injection |
20-509 |
010 |
23 |
| QUINAGLUTE
|
quinidine gluconate |
ER tablet |
16-647 |
036 |
24 |
| EVISTA
|
raloxifene HCl |
tablet |
20-815 |
006 |
27 |
| CIPRO
|
ciprofloxacin |
injection |
19-847 |
021 |
28 |
| CIPRO
|
ciprofloxacin |
suspension |
20-780 |
010 |
28 |
| CIPRO
|
ciprofloxacin |
tablet |
19-537 |
040 |
28 |
| CIPRO
IN DEXTROSE 5% |
ciprofloxacin |
injection |
19-857 |
025 |
28 |
FDA/Center for Drug Evaluation and Research
Last Updated: October 02, 2001
Originator: OPS/OGD
HTML by JFG |
