Office of Generic Drugs |
Reference Listed Drug Labeling Supplements Approved in April 2001 Click on appropriate hyperlink below to view available source document in PDF format. |
||||||
Approval Date |
Product Name |
Links to Source Documents |
Established Name | NDA No. |
Supp.No. |
|
---|---|---|---|---|---|---|
Apr 3 |
COMPAZINE |
prochlorperazine maleate tablets prochlorperazine maleate injection prochlorperazine maleate extended-release capsules prochlorperazine maleate suppositories prochlorperazine maleate extended-release capsules |
10-571 10-742 11-000 11-127 21-019 |
S-095 S-065 S-084 S-061 S-001 |
||
CRINONE |
progesterone gel 4% |
20-701 |
S-007 |
|||
CRINONE | label | progesterone gel 8% | 20-756 20-756 |
S-008 S-009 |
||
STELAZINE |
trifluperazine HCl tablets, injection,concentrate |
11-552 |
S-112 |
|||
THORAZINE |
chlorpromazine HCl tablets,capsules,injection,syrup |
11-120 |
S-086 |
|||
Apr 4 |
CLIMARA |
estradiol transdermal system |
20-375 |
S-014 |
||
DROXIA |
hydroxyurea capsules |
16-295 |
S-034 |
|||
HYDREA |
hydroxyurea capsules |
16-295 |
S-034 |
|||
Apr 5 |
CLIMARA |
estradiol transdermal system |
20-375 |
S-016 |
||
IMODIUM A-D |
label |
loperamide tablets |
19-860 |
S-018 |
||
VIRACEPT |
nelfinavir mesylate tablets nelfinavir mesylate for oral suspension |
20-778 20-779 |
S-014 S-032 |
|||
Apr 6 |
CYSTAGON |
label |
cysteamine bitartrate capsule |
20-392 |
S-005 |
|
DETROL |
tolterodine tartrate tablets |
20-771 |
S-004 |
|||
FLUMADINE |
rimantadine HCl tablets rimantadine HCl syrup |
19-649 19-650 |
S-006 S-004 |
|||
Apr 9 |
CELONTIN |
methsuximide tablets |
10-596 |
S-012 |
||
DESFERAL |
deferoxamine mesylate injection |
16-267 |
S-034 |
|||
DURAGESIC |
fentanyl transdermal system |
19-813 |
S-030 |
|||
ZARONTIN |
label | ethosuximide capsules | 12-380 |
S-025 |
||
Apr 11 |
DIASTAT |
diazepam rectal gel |
20-648 |
S-002 |
||
KLONOPIN |
clonazepam tablets |
17-533 |
S-031 |
|||
SINEMET |
carbidopa/levodopa tablets |
17-555 |
S-055 |
|||
UNIVASC |
moexipril HCl tablets |
20-312 |
S-016 |
|||
Apr 13 |
LAMISIL |
terbinafine HCl tablets |
20-539 |
S-010 |
||
PAXIL |
paroxetine HCl tablets |
20-031 |
S-026 |
|||
Apr 16 |
NOROXIN |
norfloxacin tablets |
19-384 |
S-039 |
||
Apr 17 |
ACCUPRIL |
quinapril HCl tablets |
19-885 |
S-018 |
||
Apr 18 |
INFED |
iron dextran injection |
17-441 |
S-161 |
||
TICLID |
ticlopidine hydrochloride tablets |
19-979 |
S- 018 |
|||
Apr 19 |
GLUCOPHAGE |
label |
metformin HCl tablets |
20-357 |
S-020 |
|
GLUCOPHAGE XR |
label |
metformin HCL extended-release tablets |
21-202 |
S-001 |
||
Apr 20 |
CORVERT |
ibutilide fumarate injection |
20-491 |
S-003 |
||
Apr 23 |
ZYFLO |
zileuton tablets |
20-471 |
S-008 |
||
Apr 24 |
VAGISTAT-1 |
label |
tioconazole vaginal ointment |
20-676 |
S-001 |
|
Apr 25 |
PEPCID PEPCID RPD |
famotidine tablets famotidine orally disintegrating tablets famotidine oral suspension |
19-462 20-752 19-527 |
S-029 S-004 S-023 |
||
PEPCID |
letter | label | famotidine injection |
19-510 20-249 |
S-027 S-010 |
|
Apr 26 |
MEVACOR |
lovastatin tablets |
19-643 |
S-064 |
||
Apr 27 |
ACULAR |
ketorolac tromethamine ophthalmic solution |
19-700 |
S-014 |
||
AZELEX |
azelaic acid cream |
20-428 |
S-013 |
|||
ACCOLATE | letter | label | zafirlukast tablets | 20-547 | S-014 | |
DETROL LA |
tolterodine extended-release capsules |
21-228 |
S-001 |
|||
RELENZA |
zanamivir for inhalation |
21-036 |
S-004 |
|||
Apr 30 |
PARAPLATIN |
carboplatin for injection |
19-880 |
S-016 |
||
XELODA |
capecitabine tablets |
20-896 |
S-009 |
Back to Top Labeling Review Branch Page |
FDA/Center for Drug Evaluation and Research Last Updated: October 02, 2001 Originator: OTCOM/DLIS HTML by JFG |