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Reference Listed Drug Labeling Approved in January 2001

Click on appropriate hyperlink below to view available source document in PDF format.

Approval Date

Product Name

 Established Name

NDA No.

Supp.No.
Jan 4 STROMECTOL letter label ivermectin tablets 50-742 S-005
Jan 5 EPIVIR letter label lamivudine tablets 20-564 S-011
lamivudine oral solution 20-596 S-012
EXELON letter label rivastigmine tartrate capsules 21-025 S-003
rivastigmine tartrate oral solution 20-823 S-003
STADOL letter label butorphanol tartrate nasal solution 19-890 S-015
Jan 10 FEMARA letter label letrozole tablets 20-726 S-006
Jan 11 ELIMITE letter label permethrin cream 19-855 S-005
Jan 16 ORTHO CYCLEN-21 letter label norgestimate/ethinyl estradiol tablets 19-653 S-027
ORTHO TRI-CYCLEN letter label norgestimate/ethinyl estradiol tablets 19-697 S-024
PRECEDEX letter label dexmedetomidine HCl injection 21-038 S-001
TAPAZOLE letter label methimazole tablets 07-517 S-022
Jan 17 PROSCAR letter label finasteride tablets 20-180 S-019
SYPRINE letter label trientine HCl capsules 19-194 S-006
Jan 22 COSMEGEN letter label dactinomycin for injection 50-682 S-017
Jan 23 SERZONE letter label nefazodone HCl tablets 20-152 S-025
Jan 29 CARAC letter label fluorouracil cream 20-985 S-001
Jan 30 CYTOXAN letter label cyclophosphamide tablets 12-141 S-086
cyclophosphamide for injection 12-142 S-103
KALETRA letter label lopinavir/ritonavir capsules 21-226 S-001
lopinavir/ritonavir oral solution 21-251 S-001
PROSCAR letter label finasteride tablets 20-180 S-022
Jan 31 FOSAMAX letter label alendronate sodium tablets 20-560 S-025
alendronate sodium tablets 20-560 S-024
MEGACE letter label megestrol acetate tablets 16-979 S-049
NOVANTRONE letter label mitoxantrone HCl injection 19-297 S-022

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FDA/Center for Drug Evaluation and Research
Last Updated: October 02, 2001
Originator: OTCOM/DLIS
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