Reference Listed
Drug Labeling Approved in May 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# |
May |
ACCUTANE |
isotretinoin |
capsule |
18-662 |
S-038 |
1 |
ACCUTANE |
isotretinoin |
capsule |
18-662 |
S-039 |
1 |
ACCUTANE |
isotretinoin |
capsule |
18-662 |
S-040 |
1 |
ZOMIG |
zolmitriptan |
tablet |
20-768 |
S-003 |
1 |
BUTISOL |
butabarbital
Na |
tablet |
00-793 |
S-020 |
2 |
HALDOL |
haloperidol |
tablet |
15-921 |
S-075 |
2 |
HALDOL |
haloperidol
lactate |
oral
solution |
15-922 |
S-065 |
2 |
HALDOL |
haloperidol
lactate |
injection |
15-923 |
S-066 |
2 |
XANAX |
alprazolam |
tablet |
18-276 |
S-035 |
2 |
HALDOL |
haloperidol
decanoate |
injection |
18-701 |
S-043 |
2 |
SINEMET CR |
carbidopa/levodopa |
extended-release
tablet |
19-856 |
S-015 |
2 |
RAPAMUNE |
sirolimus |
oral
solution |
21-083 |
S-002 |
3 |
AVELOX |
moxifloxacin
HCl |
tablet |
21-085 |
S-001 |
4 |
NORVIR |
ritonavir |
capsules |
20-659 |
S-023 |
8 |
NORVIR |
ritonavir |
oral
solution |
20-945 |
S-004 |
8 |
AVAPRO |
irbesartan |
tablet |
20-757 |
S-015 |
9 |
AVALIDE |
HCTZ/irbesartan |
tablet |
20-758 |
S-016 |
9 |
ALOPRIM |
allopurinol
Na |
for
injection |
20-298 |
S-001 |
12 |
NAVELBINE |
vinorelbine
tartrate |
injection |
20-388 |
S-009 |
12 |
REQUIP |
ropinirole
HCl |
tablet |
20-658 |
S-007 |
15 |
ALEVE COLD AND SINUS |
naproxen
Na/ pseudoephedrine HCl |
extended-release
tablet |
21-076 |
S-001 |
15 |
DEPAKENE |
valproic
acid |
capsule |
18-081 |
S-029 |
16 |
DEPAKENE |
valproic
acid |
syrup |
18-082 |
S-022 |
16 |
NORDITROPIN |
somatropin |
for
injection |
19-721 |
S-006 |
16 |
IOPIDINE |
apraclonidine |
ophthalmic
solution |
20-258 |
S-011 |
16 |
ESTRING |
estradiol |
vaginal
ring |
20-472 |
S-001 |
16 |
AMOXIL |
amoxicillin |
tablet |
50-754 |
S-002 |
16 |
AMOXIL |
amoxicillin |
for
oral suspension |
50-760 |
S-001 |
16 |
AMOXIL |
amoxicillin |
tablet
(chewable) |
50-761 |
S-001 |
16 |
NORPACE |
disopyramide
phosphate |
capsule |
17-447 |
S-055 |
17 |
NORPACE CR |
disopyramide
phosphate |
extended-release
capsule |
18-655 |
S-033 |
17 |
TROVAN |
trovafloxacin
mesylate |
tablet |
20-759 |
S-008 |
17 |
TROVAN PRESERVATIVE FREE |
alatrofloxacin
mesylate |
injection |
20-760 |
S-006 |
17 |
ROMAZICON |
flumazenil |
injection |
20-073 |
S-010 |
22 |
MERREM
I.V. |
meropenem |
for
injection |
50-706 |
S-005 |
23 |
TALWIN |
pentazocine
lactate |
injection |
16-194 |
S-062 |
24 |
NUROMAX |
doxacurium
Cl |
injection |
19-946 |
S-006 |
30 |
FDA/Center for Drug Evaluation and Research
Last Updated:January 06, 2006
Originator: OPS/OGD
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