Reference Listed Drug Labeling Approved in
February 2001
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Approval
Date |
Product Name |
|
|
Established Name |
NDA No. |
Supp.No. |
Feb 2 |
IMITREX |
letter |
label |
sumatriptan succinate injection |
20-080 |
S-027 |
Feb 5 |
CHIBROXIN |
letter |
label |
norfloxacin ophthalmic solution |
19-757 |
S-010 |
TOPROL-XL |
letter |
label |
metoprolol succinate tablets |
19-962 |
S-013 |
Feb 6 |
LEVATOL |
letter |
label |
penbutolol sulfate tablets |
18-976 |
S-009 |
MERREM I.V. |
letter |
label |
meropenem for injection |
50-706 |
S-007 |
SUPRAX |
letter |
label |
cefixime oral suspension |
50-622 |
S-014 |
VANCOCIN HCL |
letter |
label |
vancomycin hydrochloride capsules |
50-606 |
S-014 |
ZYVOX |
letter |
label |
linezolid tablets
linezolid injection
linezolid for oral suspension |
21-130
21-131
21-132 |
S-001
S-001
S-001 |
Feb 8 |
AVANDIA |
letter |
label |
rosiglitazone maleate tablets |
21-071 |
S-006 |
GLUCOPHAGE |
letter |
label |
metformin hydrochloride tablets |
20-357 |
S-022 |
Feb 9 |
PEPCID
PEPCID
RPD |
letter |
label |
famotidine tablets
famotidine injection
famotidine oral suspension
famotidine injection
famotidine orally
disintegrating tablets |
19-462
19-510
19-527
20-249
20-752 |
S-029
S-027
S-023
S-010
S-004 |
IMITREX |
letter |
label |
sumatriptan succinate tablets |
20-132 |
S-010 |
Feb 12 |
HUMATROPE |
letter |
label |
somatropin [rDNA origin] for injection |
19-640 |
S-026 |
MS CONTIN |
letter |
label |
morphine sulfate extended-release tablet |
19-516 |
S-015 |
PROTROPIN |
letter |
label |
somatrem for injection |
19-107 |
S-048 |
Feb 13 |
OPTICROM |
letter |
label |
cromolyn sodium ophthalmic solution |
18-155 |
S-022 |
VASOTEC |
letter |
label |
enalapril maleate tablets |
18-998 |
S-059 |
VENOFER |
letter |
label |
iron sucrose injection |
21-135 |
S-001 |
Feb 14 |
KETALAR |
letter |
label |
ketamine hydrochloride injection |
16-812 |
S-026 |
Feb 15 |
DELSYM |
letter |
label |
dextromethorphan polistirex suspension |
18-658 |
S-014 |
PAXIL |
letter |
label |
paroxetine hydrochloride
tablets
paroxetine hydrochloride
oral suspension |
20-031
20-710 |
S-031
S-009 |
Feb 16 |
MERIDIA |
letter |
label |
sibutramine HCl monohydrate capsules |
20-632 |
S-011 |
MONOPRIL-HCT |
letter |
label |
fosinopril sodium/hydrochlorothiazide tablets |
20-286 |
S-004 |
Feb 20 |
DROXIA
HYDREA |
letter |
label |
hydroxyurea capsules |
16-295 |
S-035 |
MIVACRON |
letter |
label |
mivacurium chloride injection |
20-098 |
S-012 |
Feb 22 |
DIMETANE-DX |
letter |
label |
brompheniramine maleate/pseudoephedrine HCl/dextromethorphan HBr |
19-279 |
S-010 |
ZOLOFT |
letter |
label |
sertraline hydrochloride
tablets
sertraline hydrochloride
oral concentrate |
19-839
20-990 |
S-037
S-005 |
SONATA |
letter |
label |
zaleplon capsules |
20-859 |
S-001 |
Feb 23 |
DIPRIVAN |
letter |
label |
propofol injectable emulsion |
19-627 |
S-035 |
DYAZIDE |
letter |
label |
hydrochlorothiazide/triamterene capsules |
16-042 |
S-069 |
LAMICTAL
LAMICTAL
CD |
letter |
label |
lamotrigine tablets
lamotrigine chewable
dispersible tablets |
20-241
20-764 |
S-015
S-008 |
MYLOTARG |
letter |
label |
gemtuzumab ozogamicin for injection |
21-174 |
S-002 |
PHENERGAN VC |
letter |
label |
promethazine HCl/codeine phosphate syrup |
08-604 |
S-026 |
PHENERGAN VC/CODEINE
PHENERGAN/CODEINE |
letter |
label |
promethazine
HCl/phenylephrine HCl/codeine phosphate syrup
promethazine HCl/codeine
phosphate syrup |
08-306 |
S-029 |
PHENERGAN DM |
letter |
label |
promethazine HCl/dextromethorphan HBr syrup |
11-265 |
S-027 |
REBETOL |
letter |
label |
interferon alfa-2b,ribavirin |
20-903 |
S-005 |
Feb 28 |
COPAXONE |
letter |
label |
glatiramer acetate for injection |
20-622 |
S-020 |
GLUCOVANCE |
letter |
label |
glyburide/metformin HCl tablets |
21-178 |
S-002 |
ZITHROMAX |
letter |
label |
azithromycin for injection |
50-733 |
S-005 |
