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 |