Reference Listed Drug Labeling Supplements Approved in August 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. |
Aug 1 |
LOTRIMIN AF |
letter
letter
letter |
|
clotrimazole cream
clotrimazole lotion
clotrimazole topical solution |
20-888
20-889
20-890 |
S-002
S-002
S-002 |
Aug 2 |
SINGULAIR
SINGULAIR CHEWABLE |
letter |
label |
montelukast sodium tablets |
20-829
20-830 |
S-012
S-014 |
Aug 6 |
LUPRON DEPOT-PED |
letter |
|
leuprolide acetate for depot suspension |
20-263 |
S-017 |
VONTROL |
letter |
|
diphenidol tablets |
16-033 |
S-011 |
ZOLOFT |
letter |
|
sertraline HCl tablets
sertraline HCl oral concentrate |
19-839
20-990 |
S-035
S-003 |
Aug 7 |
LOPID |
letter |
label |
gemfibrozil tablets |
18-422 |
S-041 |
PRINIVIL |
letter |
label |
lisinopril tablets |
19-558 |
S-038 |
PRINZIDE |
letter |
label |
lisinopril/hydrochlorothiazide tablets |
19-778 |
S-030 |
Aug 8 |
SERAX |
letter |
label |
oxazepam tablets and capsules |
15-539 |
S-052 |
XALATAN |
letter |
label |
latanoprost ophthalmic solution |
20-597 |
S-019 |
Aug 9 |
ULTANE |
letter |
|
sevoflurane for inhalation |
20-478 |
S-010 |
1-DAY |
letter |
label |
tioconazole vaginal ointment |
20-676 |
S-004 |
Aug 10 |
AGGRENOX |
letter |
label |
aspirin/extended-release dipyridamole capsules |
20-884 |
S-001 |
MYKROX |
letter |
|
metolazone tablets |
19-532 |
S-012 |
ZAROXOLYN |
letter |
|
metolazone tablets |
17-386 |
S-032 |
Aug 13 |
CEREBYX |
letter |
label |
fosphenytoin injection. |
20-450 |
S-005 |
CEREZYME |
letter |
|
imiglucerase for injection |
20-367 |
S-049 |
Aug 15 |
ACIPHEX |
letter |
label |
rabeprazole sodium delayed-release tablets |
20-973 |
S-008 |
ULTRAM |
letter |
label |
tramadol HCl tablets |
20-281 |
S-029 |
Aug 16 |
QUINIDEX |
letter |
label |
quinidine sulfate extended-release tablets |
12-796 |
S-049 |
Aug 17 |
AZULFIDINE
AZULFIDINE EN-TABS |
letter |
label |
sulfasalazine
tablets
sulfasalazine delayed-release tablets |
7-073 |
S-115 |
SOLARAZE |
letter |
|
diclofenac sodium gel |
21-005 |
S-001 |
Aug 20 |
TEQUIN |
letter |
label |
gatifloxacin tablets
gatifloxacin injection |
21-061
21-062 |
S-006
S-007 |
Aug 21 |
NORVIR |
letter |
label |
ritinovir oral solution |
20-659 |
S-025 |
Aug 22 |
DILAUDID |
letter |
|
hydromorphone HCl oral solution
hydromorphone HCl tablets |
19-891
19-892 |
S-004
S-004 |
Aug 23 |
DOPRAM |
letter |
|
doxapram HCl injection |
14-879 |
S-036 |
Aug 24 |
COZAAR |
letter |
label |
losartan potassium tablets |
20-386 |
S-026 |
HYZAAR |
letter |
label |
losartan potassium/hydrochlorothiazide tablets |
20-387 |
S-022 |
NICORETTE |
letter |
label |
nicotene polacrilex gum |
18-612
20-066 |
S-026
S-008 |
Aug 27 |
EPIPEN |
letter |
|
epinephrine injection |
19-430 |
S-012 |
SUFENTA |
letter |
|
sufentil citrate injection |
19-050 |
S-025 |
Aug 29 |
CLOZARIL |
letter |
label |
clozapine tablets |
19-758 |
S-044 |
Aug 30 |
PRIMATENE MIST |
letter |
label |
epinephrine inhalation |
16-126 |
S-025 |
Aug 31 |
ADENOSCAN |
letter |
|
adenosine injection |
20-059 |
S-007 |
BECONASE
BECONASE AQ |
letter |
label |
beclomethasone
dipropionate inhalation aerosol
beclomethasone dipropionate nasal spray |
18-584
19-389 |
S-027
S-023 |
Reference Listed Drug Efficacy Supplements Approved in August 2001
Click on appropriate
hyperlink below to view available source document in PDF format. |
| Aug 2 |
BIAXIN XL |
letter |
label |
clarithromycin extended release tablets |
50-775 |
S-001 |
| Efficacy Claim: For use in Community-Acquired Pneumonia due to
Haemophilus parainfluenzae, Moraxella catarrhalis, Streptococcus pneumoniae, Chlamydia
pneumonia (TWAR) or Mycoplasma Pneumoniae |
Aug 16 |
EPIVIR-HBV |
letter |
label |
lamivudine
tablets
lamivudine oral solution |
21-003
21-004 |
S-002
S-002 |
| Efficacy Claim: For the
treatment of hepatitis B in pediatric patients ages 2-17 years |
| Aug 20 |
AREDIA |
letter |
label |
pamidronate
disodium injection |
20-036 |
S-024 |
| Efficacy Claim: For the treatment of moderate and severe
hypercalcemia of malignancy, with or without bone metastases |
| Aug 22 |
VISUDYNE |
letter |
label |
verteporfin for
injection |
21-119 |
S-001 |
| Efficacy Claim: For the treatment of patients with
predominantly classic subfoveal choroidal neovascularization due to macular degeneration,
presumed ocular histoplasmosis or pathologic myopia |
| Aug 28 |
TOPAMAX
TOPAMAX SPRINKLE |
letter |
label |
topiramate
tablets
topiramate capsules |
20-505
20-844 |
S-002
S-010 |
| Efficacy Claim: For the use of Topamax as adjunctive therapy in
patients 2 years and older with seizures associated with Lennox-Gastaut syndrome |
Original NDAs Approved in August 2001
Click on appropriate
hyperlink below to view available source document in PDF format. |
Aug 10 |
NATRECOR |
letter |
label |
nesiritide citrate for injection |
20-920 |
| Indication(s): For the intravenous treatment of patients with acutely
decompensated congestive heart failure who have dyspnea at rest or with minimal activity |
Aug 15 |
ULTRACET |
letter |
label |
acetaminophen/tramadol HCL tablet |
21-123 |
| Indication(s): For the shor-term management of acute pain |
Aug 20 |
ZOMETA |
letter |
label |
zoledronic acid injection |
21-223 |
| Indication(s): For the treatment of hypercalcemia of malignancy |
Aug 29 |
SPECTRACEF |
letter |
label |
cefditoren pivoxil tablets |
21-222 |
| Indication(s): For the treatment of acute bacterial exacerbation of
chronic bronchitis, pharyngitis/tonsillitis, and uncomplicated skin and skin structure
infections |
Back to Top
Labeling
Review Branch Page
