Reference Listed Drug Labeling
Supplements Approved in January 2002
Click on appropriate hyperlink below
to view available source document in PDF format. |
| Approval
Date |
Product Name |
|
|
Active Ingredient(s) |
Dosage Form |
NDA No |
Supp No |
Jan 2 |
CEREBYX |
letter |
label |
fosphenytoin Na |
injection |
20-450 |
S-007 |
|
VIAGRA |
letter |
label |
sildenafil citrate |
tablet |
20-895 |
S-012 |
Jan 3 |
FOCALIN |
letter |
label |
dexmethylphenidate HCl |
tablet |
21-278 |
S-001 |
| |
NARDIL |
letter |
label |
phenelzine sulfate |
tablet |
11-909 |
S-030 |
|
|
TOFRANIL-PM |
letter |
label |
imipramine pamoate |
capsule |
17-090 |
S-067 |
Jan 7 |
ACTOS |
letter |
|
pioglitazone HCl |
tablet |
21-073 |
S-016 |
| |
ALKERAN |
letter |
label |
melphalan |
tablet |
14-691 |
S-023 |
| |
ALKERAN |
letter |
label |
melphalan |
injection |
20-207 |
S-005 |
| |
ZANTAC |
letter |
label |
ranitidine
HCl |
injection |
19-090 |
S-045 |
| |
ZANTAC |
letter |
label |
ranitidine
HCl |
injection |
19-593 |
S-033 |
| |
ZANTAC |
letter |
label |
ranitidine
HCl |
syrup |
19-675 |
S-025 |
| |
ZANTAC 150 |
letter |
label |
ranitidine
HCl |
tablet |
20-251 |
S-011 |
| |
ZANTAC 300 |
letter |
label |
ranitidine
HCl |
tablet |
18-703 |
S-061 |
|
|
ZANTAC 300 |
letter |
label |
ranitidine HCl |
capsule |
20-095 |
S-013 |
Jan 8 |
GLUCOPHAGE |
letter |
|
metformin HCl |
tablet |
20-357 |
S-024 |
| |
GLUCOPHAGE XR |
letter |
|
metformin HCl |
extended-release tablet |
21-202 |
S-003 |
|
|
SERZONE |
letter |
label |
nefazodone HCl |
tablet |
20-152 |
S-029 |
Jan 9 |
LOVENOX |
letter |
label |
enoxaprin Na |
injection |
20-164 |
S-046 |
Jan 10 |
DOXIL |
letter |
|
doxorubicin HCl |
injection |
50-718 |
S-010 |
|
PITOCIN |
letter |
|
oxytocin |
injection |
18-261 |
S-021 |
Jan 11 |
RITALIN |
letter |
label |
methylphenidate HCl |
tablet |
10-187 |
S-060 |
Jan 14 |
CLOZARIL |
letter |
label |
clozapine |
tablet |
19-758 |
S-045 |
|
STADOL |
letter |
label |
butorphanol tartrate |
nasal spray |
19-890 |
S-017 |
Jan 15 |
ANDRODERM |
letter |
|
testosterone |
transdermal system |
20-489 |
S-007 |
| |
CAVERJECT |
letter |
|
alprostadil |
injection |
20-379 |
S-011 |
| |
NORPLANT SYSTEM |
letter |
label |
levonorgestrel |
implant |
20-088 |
S-016 |
| |
OXYCONTIN |
letter |
label |
oxycodone HCl |
extended-release tablet |
20-553 |
S-024 |
|
|
TRELSTAR DEPOT |
letter |
label |
triptorelin pamoate |
injectable suspension |
20-715 |
S-004 |
Jan 17 |
NIX |
letter |
|
permethrin |
shampoo |
19-918 |
S-009 |
Jan 18 |
CAFCIT |
letter |
label |
caffeine citrate |
injection |
20-793 |
S-003 |
| |
CLAFORAN |
letter |
|
cefotaxime Na |
injection |
50-547 |
S-047 |
| |
CLAFORAN |
letter |
|
cefotaxime Na |
injection |
50-596 |
S-023 |
| |
DIPENTUM |
letter |
|
olsalazine Na |
capsule |
19-715 |
S-018 |
| |
EMCYT |
letter |
|
estramustine phosphate
Na |
capsule |
18-045 |
S-016 |
| |
PROSTEP |
letter |
|
nicotine |
transdermal system |
19-983 |
S-016 |
|
|
TEMODAR |
letter |
label |
temozolomide |
capsule |
21-029 |
S-004 |
Jan 23 |
ALUPENT |
letter |
|
metaproterenol sulfate |
inhalation solution |
18-761 |
S-016 |
| |
CARDURA |
letter |
label |
doxazosin mesylate |
tablet |
19-668 |
S-015 |
| |
HYTRIN |
letter |
label |
terazosin HCl |
tablet |
19-057 |
S-015 |
|
|
HYTRIN |
letter |
label |
terazosin HCl |
capsule |
20-347 |
S-006 |
Jan 24 |
DELSYM |
letter |
|
dextromethorphan polistirex |
oral suspension |
18-658 |
S-015 |
Jan 25 |
CRIXIVAN |
letter |
label |
indinavir Na |
capsule |
20-685 |
S-053 |
Jan 28 |
PLAVIX |
letter |
label |
clopidogrel bisulfate |
tablet |
20-839 |
S-018 |
| |
VIDEX EC |
letter |
label |
didanosine |
delayed-release capsules |
21-183 |
S-001 |
| |
ZIAGEN |
letter |
|
abacavir sulfate |
tablet |
20-977 |
S-005 |
|
|
ZIAGEN |
letter |
|
abacavir sulfate |
oral solution |
20-978 |
S-006 |
Jan 29 |
KLONOPIN |
letter |
|
clonazepam |
tablet |
17-533 |
S-037 |
| |
ZOMIG |
letter |
|
zolmitriptan |
tablet |
20-768 |
S-006 |
|
|
ZOVIRAX |
letter |
|
acyclovir Na |
injection |
18-603 |
S-025 |
Jan 30 |
MINOCIN |
letter |
|
minocycline HCl |
injection |
50-444 |
S-034 |
| |
NEURONTIN |
letter |
label |
gabapentin |
capsule |
20-235 |
S-022 |
| |
NEURONTIN |
letter |
label |
gabapentin |
tablet |
20-882 |
S-008 |
| |
NEURONTIN |
letter |
label |
gabapentin |
oral solution |
21-129 |
S-009 |
|
|
PEPCID AC |
letter |
label |
famotadine |
tablet |
20-325 |
S-013 |
Jan 31 |
PEPCID AC |
letter |
label |
famotadine |
gelatin coated tablet |
20-801 |
S-007 |
Reference Listed Drug Efficacy
Supplements Approved in January 2002
Click on appropriate hyperlink below
to view available source document in PDF format. |
| Approval
Date |
Product Name |
|
|
Active Ingredient(s) |
Dosage Form |
NDA No |
Supp No |
Jan 18 |
CUTIVATE |
letter |
label |
fluticasone propionate |
ointment |
19-957 |
S-
011 |
|
Efficacy claim: Usage in pediatric patients age 3 months and
older |
| |
KALETRA |
letter |
label |
lopinavir/ritonavir |
capsule |
21-226 |
S-003 |
|
Efficacy
claim: Use in combination with other antiretroviral agents for the treatment of
HIV-infection |
| |
KALETRA |
letter |
label |
lopinavir/ritonavir |
oral solution |
21-251 |
S-004 |
|
Efficacy
claim: Use in combination with other antiretroviral agents for the treatment of
HIV-infection |
| |
PRANDIN |
letter |
label |
repaglinide |
tablet |
20-741 |
S-012 |
|
|
Efficacy claim: Addition
of information based on the Diabetes Complications and Control Trial (DCCT) |
Jan 24 |
DEPACON |
letter |
label |
valproate Na |
injection |
20-593 |
S-006 |
|
|
Efficacy claim: Increases
the infusion rate |
Jan 25 |
DAYPRO |
letter |
|
oxaprozin |
tablet |
18-841 |
S-016 |
|
|
Efficacy claim: New
pediatric useage information |
Jan 29 |
VIDEX EC |
letter |
label |
didanosine |
delayed-release capsules |
21-183 |
S-002 |
| |
Efficacy claim: Inclusion
of safety and efficacy data in labeling based on clinical trial. |
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