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Office of Generic Drugs |
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| Reference Listed Drug Labeling and Efficacy Supplements Approved in November 2002 | ||||||
| Click on appropriate hyperlink below to view available source document in PDF format | ||||||
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Approval Date |
Product Name |
Source Documents |
Active Ingredient(s)/Dosage Form |
Document ID No. | ||
| Nov 1 |
ALLEGRA-D |
letter |
fexofenadine HCl/pseudoephedrine HCl ER tablets. |
20-786 | SLR 012 | |
| Nov 1 |
FLOVENT DISKUS |
letter |
fluticasone dipropionate inhalation powder |
20-833 | SLR 002 | |
| Nov 1 |
FRAGMIN |
letter |
dalteparin Na injection |
20-287 | SLR 027 | |
| Nov 1 |
TRINALIN |
letter |
azatadine maleate/pseudoephedrine sulfate tablets |
18-506 | SLR 024 | |
| Nov 1 |
VASERETIC |
letter |
enalapril maleate/hydrochlorothiazide tablets |
19-221 | SLR 027 | |
| Nov 1 |
VASOTEC IV |
letter |
enalaprilat injection |
19-309 | SLR 025 | |
| Nov 4 |
OPTIMINE |
letter |
azatadine maleate tablets. |
17-601 | SLR 020 | |
| Nov 4 |
PHOSLO |
letter | label |
calcium acetate tablets |
19-976 | SLR 005 |
| Nov 5 |
CORTROSYN |
letter | label |
cosyntropin for injection |
16-750 | SLR 018 |
| Nov 5 |
ETOPOPHOS |
letter | label |
etoposide phosphate for injection |
20-457 | SLR 006 |
| Nov 5 |
NAVELBINE |
letter | label |
vinorelbine tartrate injection |
20-388 | SE8 014 |
| Nov 5 |
VEPESID |
letter | label |
etoposide injection |
19-557 | SLR 028 |
| Nov 5 |
VEPESID |
letter | label |
etoposide injection |
18-768 | SLR 045 |
| Nov 7 |
HYZAAR |
letter | label |
losartan potassium/hydrochlorothiazide tablets |
20-387 | SLR 024 |
| Nov 8 |
ACIPHEX |
letter | label |
rabeprazole Na delayed-release tablets |
20-973 | SE8 013 |
| Nov 8 |
PLATINOL |
letter | label |
cisplatin injection |
18-057 | SLR 076 |
| Nov 8 |
PRINZIDE |
letter | label |
lisinopril/hydrochlorothiazide tablets |
19-778 | SLR 032 |
| Nov 13 |
CEREZYME |
label |
imiglucerase for injection |
20-367 | SLR 055 | |
| Nov 13 |
REBETRON |
letter | label |
rebetol/Intron A combination therapy |
20-903 | SLR 025 |
| Nov 14 |
DORAL |
letter | label |
quazepam tablets |
18-708 | SLR 014 |
| Nov 14 |
KETALAR |
letter | label |
ketamine HCl for injection |
16-812 | SLR 032 |
| Nov 14 |
ORAP |
letter | label |
pimozide tablets |
17-473 | SLR 038 |
| Nov 14 |
REMERON SOLTAB |
letter | label |
mirtazapine orally disintegrating tablets |
21-208 | SLR 006 |
| Nov 19 |
CELEXA |
letter | label |
citalopram HBr tablets |
21-046 | SLR 003 |
| Nov 19 |
CELEXA |
letter | label |
citalopram HBr oral solution |
20-822 | SLR 019 |
| Nov 19 |
FELBATOL |
letter | label |
felbamate tablets |
20-189 | SLR 018 |
| Nov 19 |
FRAGMIN |
letter | label |
dalteparin Na injection |
20-287 | SLR 029 |
| Nov 19 |
RISPERDAL |
letter | label |
risperidone oral solution |
20-588 | SLR 015 |
| Nov 19 |
RISPERDAL |
letter | label |
risperidone tablets |
20-272 | SLR 024 |
| Nov 21 |
CANCIDAS |
letter | label |
caspofungin acetate injection |
21-227 | SLR 005 |
| Nov 22 |
PREVPAC |
letter | label |
ansoprazole/amoxicillin/clarithromycin |
50-757 | SLR 006 |
| Nov 25 |
MIOSTAT |
letter | label |
carbachol intraocular solution |
16-968 | SLR 020 |
| Nov 25 |
VISUDYNE |
letter | label |
verteporfin injection |
21-119 | SLR 005 |
| Nov 26 |
PAH |
letter | label |
aminohippurate Na injection |
05-619 | SLR 018 |
| Nov 26 |
STARLIX |
letter | label |
nateglinide tablets |
21-204 | SLR 005 |
| Nov 26 |
TOPAMAX |
letter | label |
topiramate tablets |
20-505 | SLR 016 |
| Nov 26 |
TOPAMAX SPRINKLE |
letter | label |
topiramate capsules |
20-844 | SLR 013 |
| Nov 26 |
VOLTAREN |
letter | label |
diclofenac Na tablets |
19-201 | SLR 018 |
| Nov 27 |
CLARITIN |
letter | label |
loratadine syrup |
20-641 | SE6 009 |
| Nov 27 |
CLARITIN |
letter | label |
loratadine tabelts |
19-658 | SE6 018 |
| Nov 27 |
CLARITIN REDITABS |
letter | label |
loratadine orally disintigrating tablets |
20-704 | SE6 008 |
| Nov 27 |
CLARITIN-D 12 |
letter | label |
loratadine/pseudoephedrine sulfate ER tablets |
19-670 | SE6 018 |
| Nov 27 |
CLARITIN-D 24 |
letter | label |
loratadine/pseudoephedrine sulfate ER tablets |
20-470 | SE6 016 |
| Nov 27 |
KALETRA |
letter | label |
lopinavir/ritonavir oral solution |
21-251 | SE7 005 |
| Nov 27 |
KALETRA |
letter | label |
lopinavir/ritonavir capsules |
21-226 | SE7 006 |
| Nov 27 |
PREMARIN |
letter | label |
conjugated estrogens tablets |
04-782 | SLR 128 |
| Nov 27 |
PREMPRO |
letter | label |
conjugated estrogens /medroxyprogeterone acetate tablets |
20-527 | SLR 029 |
| Nov 27 |
TAXOTERE |
label |
docetaxel injection |
20-449 | SE1 018 | |
| Nov 27 |
ZANAFLEX |
letter | label |
tizanidine tablets |
20-397 | SLR 014 |
| FDA/Center for Drug Evaluation and Research Last Updated: January 18, 2006 Originator: OTCOM/DLIS HTML by JFG |
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