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Reference
Listed Drug Labeling and Efficacy Supplements Approved in December
2002
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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. |
|
Dec 2
|
VIREAD
|
letter |
label |
tenofovir disoproxil fumarate tablets
|
21-356 |
SLR 001 |
|
|
AVANDIA
|
letter |
|
rosiglitazone maleate tablets
|
21-071 |
SLR 008 |
|
Dec 3
|
PREVACID
|
letter |
|
lansoprazole delayed-release capsules
|
21-281 |
SLR 004 |
|
|
PREVACID
|
letter |
|
lansoprazole oral suspension
|
20-406 |
SLR 048 |
|
Dec 4
|
ARIXTRA
|
letter |
label |
fondaparinux Na injection
|
21-345 |
SLR 001 |
|
Dec 5
|
RYTHMOL
|
letter |
|
propafenone HCl tablets
|
19-151 |
SLR 009 |
|
Dec 11
|
ULTANE
|
letter |
|
sevoflurane
|
20-478 |
SLR 007 |
|
Dec 12
|
HELIDAC
|
letter |
|
bismuth
subsalicylate/ metronidazole/ tetracycline HCl
|
50-719 |
SLR 006 |
|
|
TRINALIN
|
letter |
|
azatadine maleate/seudoephedrine sulfate tablets
|
18-506 |
SLR 025 |
|
|
ALDARA
|
letter |
label |
imiquimod cream
|
20-723 |
SLR 010 |
|
|
ELOCON
|
letter |
label |
mometasone furoate ointment
|
19-543 |
SLR 014 |
|
Dec 15
|
MYCELEX
|
letter |
label |
clotrimazole troche
|
18-713 |
SLR 019 |
|
|
PERIOCHIP
|
letter |
|
chlorhexidine gluconate
|
20-774 |
SLR 003 |
|
|
STATICIN
|
letter |
label |
erythromycin topical solution
|
50-526 |
SLR 010 |
|
|
BECONASE
|
letter |
|
beclomethasone dopropionate nasal spray
|
18-584 |
SLR 026 |
|
|
BECONASE AQ
|
letter |
|
beclomethasone dopropionate nasal spray
|
19-389 |
SLR 025 |
|
Dec 16
|
PLEGISOL
|
letter |
|
cardioplegic solution
|
18-608 |
SLR 031 |
|
|
PRILOSEC
|
letter |
|
omeprazole delayed-release capsules
|
19-810 |
SLR 076 |
|
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UREAPHIL
|
letter |
|
urea injection
|
12-154 |
SLR 023 |
|
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ZYFLO
|
letter |
|
zileutin tablets
|
20-471 |
SLR 009 |
|
Dec 17
|
LOTRISONE
|
letter |
|
clotrimazole/betamethasone diproprionate lotion
|
20-010 |
SLR 003 |
|
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CEFOBID
|
letter |
|
cefoperazone Na injection
|
50-551 |
SLR 042 |
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|
CLOZARIL
|
letter |
|
clozapine tablets
|
19-758 |
SE1 047 |
|
Dec 18
|
MONUROL
|
letter |
|
fosfomycin tromethamine sachet
|
50-717 |
SLR 004 |
|
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RETROVIR
|
letter |
|
zidovudine capsules
|
19-655 |
SLR 038 |
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RETROVIR
|
letter |
|
zidovudine syrup
|
20-518 |
SLR 010 |
|
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BECONASE AQ
|
letter |
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beclomethasone dopropionate nasal spray
|
19-389 |
SLR 021 |
|
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IMURAN
|
letter |
|
azathioprine injection
|
17-391 |
SLR 011 |
|
|
IMURAN
|
letter |
|
azathioprine tablets
|
16-324 |
SLR 026 |
|
Dec 19
|
TEQUIN
|
letter |
|
gatifloxacin tablets
|
21-062 |
SLR 015 |
|
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TEQUIN
|
letter |
|
gatifloxacin injection
|
21-061 |
SLR 015 |
|
|
ZYVOX
|
letter |
|
linezolid tablets
|
21-130 |
SLR 002 |
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ZYVOX
|
letter |
|
linezolid injection
|
21-131 |
SLR 002 |
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ZYVOX
|
letter |
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linezolid oral suspension
|
21-132 |
SLR 002 |
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COLY-MYCIN M
|
letter |
|
colistimethate injection
|
50-108 |
SLR 023 |
|
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CORTISPORIN
|
letter |
|
polymyxin B sulfate/neomycin sulfate/hydrocortisone acetate cream
|
50-218 |
SLR 051 |
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DEPAKOTE ER
|
letter |
|
divalproex extended-release tablets
|
21-168 |
SLR 004 |
|
Dec 20
|
GLEEVEC
|
letter |
label |
imatinib mesylate capsules
|
21-335 |
SE1 004 |
|
|
MATULANE
|
letter |
|
procarbazine HCl) Capsules
|
16-785 |
SLR 035 |
|
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OLUX FOAM
|
letter |
|
clobetasol propionate foam
|
21-142 |
SE1 004 |
|
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XALATAN
|
letter |
|
latanoprost ophthalmic solution
|
20-597 |
SE1 010 |
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ZONALON
|
letter |
|
doxepin HCl cream
|
20-126 |
SLR 006 |
|
Dec 23
|
BUSULFEX
|
letter |
|
busulfan injection
|
20-954 |
SLR 001 |
|
|
PHENERGAN
|
letter |
|
promethazine HCl suppositories
|
10-926 |
SLR 022 |
|
Dec 26
|
PHENERGAN
|
letter |
|
promethazine HCl
|
11-689 |
SLR 020 |
|
|
PHENERGAN
|
letter |
|
promethazine HCl tablets
|
07-935 |
SLR 028 |
|
|
SINGULAIR
|
letter |
|
montelukast Na tablets
|
20-829 |
SE1 017 |
|
|
SINGULAIR
|
letter |
|
montelukast Na oral granules
|
21-409 |
SE1 003 |
|
Dec 31
|
SINGULAIR
|
letter |
|
montelukast Na chewable tablets
|
20-830 |
SE1 020 |
|
|
VIRAMUNE
|
letter |
|
nevirapine tablets
|
20-636 |
SLR 016 |
|
|
VIRAMUNE
|
letter |
|
nevirapine suspension
|
20-933 |
SLR 006 |
