Reference Listed Drug Labeling Approved in
March 2001
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format. |
Approval Date |
Product Name |
|
|
Established Name |
NDA No. |
Supp.No. |
Mar 1 |
LUPRON DEPOT 7.5 mg |
letter |
label |
leuprolide acetate for injectable
suspension |
19-732 |
S-020 |
| LUPRON DEPOT 3.75 mg |
letter |
label |
leuprolide acetate for injectable
suspension |
20-011 |
S-020 |
| LUPRON DEPOT 3 month 11.25 mg |
letter |
label |
leuprolide acetate for injectable
suspension |
20-708 |
S-010 |
| LUPRON DEPOT 4 month 30 mg |
letter |
label |
leuprolide acetate for injectable
suspension |
20-517 |
S-010 |
| LUPRON DEPOT 3 month 22.5 mg |
letter |
label |
leuprolide acetate for injectable
suspension |
20-517 |
S-010 |
Mar
2 |
AXID |
letter |
label |
nizatidine
capsules |
19-508 |
S-030 |
Mar
6 |
ALEVE |
letter |
label |
naproxen
sodium tablets |
20-204 |
S-007 |
EPIVIR |
letter |
label |
lamivudine
tablets
lamivudine
oral solution |
20-564
20-596 |
S-012
S-013 |
NORVIR |
letter |
label |
ritonavir
oral solution |
20-659 |
S-026 |
Mar
7 |
TEGRETOL
TEGRETOL-XR |
letter |
label |
carbamazepine
tablets
carbamazepine
chewable tablets
carbamazepine
oral suspension
carbamazepine
extended-release tablets |
16-608
18-281
18-927
20-234 |
S-090
S-039
S-031
S-017 |
Mar
8 |
PITOCIN |
letter |
label |
oxytocin
injection |
18-261 |
S-020 |
URSO |
letter |
label |
ursodiol
tablets |
20-675 |
S-007 |
Mar
13 |
KALETRA |
letter |
label |
lopinavir/ritonavir
capsules
lopinavir/ritonavir
oral solution |
21-226
21-251 |
S-002
S-002 |
REBETOL |
letter |
label |
interferon
alfa-2b (recombinant) for Injection/ribavirin |
20-903 |
S-007 |
Mar 14 |
PEPCID tablets |
letter |
label |
famotidine
tablets
famotidine
for oral suspension
famotidine
orally disintegrating tablets |
19-462
19-527
20-752 |
S-031
S-025
S-006 |
PEPCID injection |
letter |
label |
famotidine
injection
famotidine
injection (premixed) |
19-510
20-249 |
S-029
S-012 |
Mar
15 |
MELLARIL
MELLARIL-S |
letter |
label |
thioridazine
HCl tablets
thioridazine
HCl oral suspension |
11-808
17-923 |
S-178
S-049 |
PARNATE |
letter |
label |
tranylcypromine
sulfate tablets |
12-342 |
S-051 |
SERENTIL |
letter |
label |
mesoridazine
besylate tablets
mesoridazine
besylate injection
mesoridazine
besylate oral solution |
16-774
16-775
16-997 |
S-073
S-041
S-041 |
TRILAFON |
letter |
label |
perphenazine
tablets
perphenazine
injection |
10-775
11-213 |
S-029
S-021 |
Mar
21 |
ATARAX |
letter |
label |
hydroxyzine
HCl tablets
hydroxyzine
HCl syrup |
10-392
10-485 |
S-041
S-018 |
CRIXIVAN |
letter |
label |
indinavir
sulfate capsules |
20-685 |
S-041 |
SERZONE |
letter |
label |
nefazodone
HCl tablets |
20-152 |
S-026 |
VISTARIL |
letter |
label |
hydroxyzine
pamoate injection
hydroxyzine
pamoate capsules |
11-111
11-459 |
S-033
S-036 |
Mar
23 |
AGGRASTAT |
letter |
label |
tirofiban
hydrochloride injection
tirofiban
hydrochloride injection |
20-912
20-913 |
S-007
S-006 |
EULEXIN |
letter |
label |
flutamide
capsules |
18-554 |
S-021 |
OVRAL |
letter |
label |
norgestrel/ethinyl
estradiol tablets |
16-672 |
S-046 |
Mar
27 |
CYKLOKAPRON |
letter |
label |
tranex
acid injection |
19-281 |
S-013 |
ELAVIL |
letter |
label |
amitriptyline
hydrochloride tablets
amitriptyline
hydrochloride injection |
12-703
12-704 |
S-092
S-045 |
NASALCROM |
letter |
label |
cromolyn
sodium nasal solution |
20-463 |
S-002 |
NASAREL |
letter |
label |
flunisolide
nasal solution |
20-409 |
S-006 |
SEROQUEL |
letter |
label |
quetiapine
fumarate tablets |
20-639 |
S-011 |
Mar
29 |
FAMVIR |
letter |
label |
famciclovir
tablets |
20-363 |
S-019 |
FLOVENT |
letter |
label |
fluticasone
propionate inhalation powder |
20-549 |
S-008 |
Mar
30 |
BAYCOL |
letter |
label |
cerivastatin
sodium tablets |
20-740 |
S-006 |
EULEXIN |
letter |
label |
flutamide
capsules |
18-554 |
S-022 |
ORLAAM |
letter |
label |
levomethadyl
acetate HCl |
20-315 |
S-006 |
RETROVIR |
letter |
label |
zidovudine
capsules
zidovudine
tablets |
19-655
20-518 |
S-032
S-004 |
ULTANE |
letter |
label |
sevoflurane |
20-478 |
S-006 |
