Drug Approvals for August 2001

Definitions and Notes

Original New Drug Applications

Original Application #: 021222
Approval Date: 29-AUG-01
Trade Name: SPECTRACEF
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: TAP PHARMACEUTICAL PRODUCTS INC
Active Ingredient(s): CEFDITOREN PIVOXIL
OTC/RX Status: RX
Indication(s): For the treatment of acute bacterial exacerbation of chronic bronchitis, pharyngitis/tonsillitis, and uncomplicated skin and skin structure infections

Original Application #: 021223
Approval Date: 20-AUG-01
Trade Name: ZOMETA
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: INJECTABLE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): ZOLEDRONIC ACID
OTC/RX Status: RX
Indication(s): For the treatment of hypercalcemia of malignancy

Original Application #: 021123
Approval Date: 15-AUG-01
Trade Name: ULTRACET
Chemical Type: 4
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): For the shor-term management of acute pain

Original Application #: 020920
Approval Date: 10-AUG-01
Trade Name: NATRECOR
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: SCIOS INC
Active Ingredient(s): NESIRITIDE CITRATE
OTC/RX Status: RX
Indication(s): For the intravenous treatment of patients with acutely decompensated congestive heart failure who have dyspnea at rest or with minimal activity

Efficacy Supplemental New Drug Applications

Application #: 020844 Efficacy Supplement#: 010
Type: SE1 to Original New Drug Application
Approval Date: 28-AUG-01
Trade Name: TOPAMAX
Dosage Form: CAPSULE
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): TOPIRAMATE
OTC/RX Status: RX
Efficacy Claim: For the use of Topamax as adjunctive therapy in patients 2 years and older with seizures associated with Lennox-Gastaut syndrome

Application #: 020505 Efficacy Supplement#: 002
Type: SE1 to Original New Drug Application
Approval Date: 28-AUG-01
Trade Name: TOPAMAX
Dosage Form: TABLET
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): TOPIRAMATE
OTC/RX Status: RX
Efficacy Claim: For the use of Topamax as adjunctive therapy in patients 2 years and older with seizures associated with Lennox-Gastaut syndrome

Application #: 021119 Efficacy Supplement#: 001
Type: SE1 to Original New Drug Application
Approval Date: 22-AUG-01
Trade Name: VISUDYNE
Dosage Form:INJECTABLE
Applicant: QLT INC
Active Ingredient(s): VERTEPORFIN
OTC/RX Status: RX
Efficacy Claim: For the treatment of patients with predominantly classic subfoveal choroidal neovascularization due to macular degeneration, presumed ocular histoplasmosis or pathologic myopia

Application #: 020036 Efficacy Supplement#: 024
Type: SE2 to Original New Drug Application
Approval Date: 20-AUG-01
Trade Name: AREDIA
Dosage Form: INJECTABLE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): PAMIDRONATE DISODIUM
OTC/RX Status: RX
Efficacy Claim: For the treatment of moderate and severe hypercalcemia of malignancy, with or without bone metastases

Application #: 021004 Efficacy Supplement#: 002
Type: SE1 to Original New Drug Application
Approval Date: 16-AUG-01
Trade Name: EPIVIR-HBV
Dosage Form: SOLUTION
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): LAMIVUDINE
OTC/RX Status: RX
Efficacy Claim: For the treatment of hepatitis B in pediatric patients ages 2-17 years

Application #: 021003 Efficacy Supplement#: 002
Type: SE1 to Original New Drug Application
Approval Date: 16-AUG-01
Trade Name: EPIVIR-HBV
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): LAMIVUDINE
OTC/RX Status: RX
Efficacy Claim: For the treatment of hepatitis B in pediatric patients ages 2-17 years

Application #: 050775 Efficacy Supplement #: 001
Type: SE1 to Original New Drug Application
Approval Date: 02-AUG-01
Trade Name: BIAXIN XL
Dosage Form: TABLET, EXTENDED-RELEASE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): CLARITHROMYCIN
OTC/RX Status: RX
Efficacy Claim: For use in Community-Acquired Pneumonia due to Haemophilus parainfluenzae, Moraxella catarrhalis, Streptococcus pneumoniae, Chlamydia pneumonia (TWAR) or Mycoplasma Pneumoniae

Approvable Original New Drug Applications

Original Abbreviated New Drug Applications

Original Abbreviated Application #: 075826
Tentative Approval Date: 31-AUG-01
Trade Name: PROPRANOLOL HYDROCHLORIDE
Dosage Form: INJECTABLE
Applicant: AMERICAN PHARMACEUTICAL PARTNERS, INC.
Active Ingredient(s): PROPRANOLOL HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application #: 040427
Tentative Approval Date: 30-AUG-01
Trade Name: PHENTERMINE HYDROCHLORIDE
Dosage Form: CAPSULE
Applicant:ABLE LABORATORIES, INC.
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application #: 040402
Tentative Approval Date: 30-AUG-01
Trade Name: PHENTERMINE HYDROCHLORIDE
Dosage Form: TABLET
Applicant:ABLE LABORATORIES, INC.
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application #: 040403
Tentative Approval Date: 30-AUG-01
Trade Name: PHENTERMINE HYDROCHLORIDE
Dosage Form: CAPSULE
Applicant:ABLE LABORATORIES, INC.
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application #: 076045
Tentative Approval Date: 29-AUG-01
Trade Name: LORAZEPAM
Dosage Form: TABLET
Applicant: RANBAXY LABORATORIES LIMITED
Active Ingredient(s): LORAZEPAM
OTC/RX Status: RX

Original Abbreviated Application #: 076035
Tentative Approval Date: 29-AUG-01
Trade Name: HALOPERIDOL
Dosage Form: INJECTABLE
Applicant: GENSIA SICOR PHARMACEUTICALS, INC.
Active Ingredient(s): HALOPERIDOL
OTC/RX Status: RX

Original Abbreviated Application #: 040362
Tentative Approval Date: 29-AUG-01
Trade Name: PREDNISONE
Dosage Form: TABLET
Applicant: TRIGEN LABORATORIES, INC.
Active Ingredient(s): PREDNISONE
OTC/RX Status: RX

Original Abbreviated Application # 075733
Approval Date: 22-AUG-01
Trade Name: CLOBETASOL PROPIONATE
Dosage Form: EMULSION, CREAM
Applicant: STIEFEL LABORATORIES INC
Active Ingredient(s): CLOBETASOL PROPIONATE
OTC/RX Status: RX

Original Abbreviated Application # 074911
Approval Date: 22-AUG-01
Trade Name: PHRENILIN
Dosage Form: CAPSULE
Applicant: AMARIN PHARMACEUTICALS
Active Ingredient(s): ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
OTC/RX Status: RX

Original Abbreviated Application # 040424
Approval Date: 20-AUG-01
Trade Name: SPIRONOLACTONE
Dosage Form: TABLET
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): SPIRONOLACTONE
OTC/RX Status: RX

Original Abbreviated Application # 065013
Approval Date: 17-AUG-01
Trade Name: TOBRAMYCIN
Dosage Form: INJECTABLE
Applicant: PHARMA-TEK INC
Active Ingredient(s): TOBRAMYCIN
OTC/RX Status: RX

Original Abbreviated Application # 075758
Approval Date: 17-AUG-01
Trade Name: FAMOTIDINE
Dosage Form: TABLET
Applicant: REDDY'S LABORATORIES LIMITED
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX

Original Abbreviated Application # 075851
Approval Date: 17-AUG-01
Trade Name: OXAPROZIN
Dosage Form: TABLET
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): OXAPROZIN
OTC/RX Status: RX

Original Abbreviated Application # 075759
Approval Date: 8-AUG-01
Trade Name: BUTORPHANOL TARTRATE
Dosage Form: SPRAY
Applicant: ESI LEDERLE
Active Ingredient(s): BUTORPHANOL TARTRATE
OTC/RX Status: RX

Original Abbreviated Application # 075506
Approval Date: 02-AUG-01
Trade Name: FLUOXETINE HCL
Dosage Form: SOLUTION
Applicant: TEVA PHARMACEUTICALS USA INC
Active Ingredient(s): FLUOXETINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075465
Approval Date: 02-AUG-01
Trade Name: FLUOXETINE
Dosage Form: CAPSULE
Applicant: DR REDDYS LABORATORIES LTD
Active Ingredient(s): FLUOXETINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075049
Approval Date: 02-AUG-01
Trade Name: FLUOXETINE HCL
Dosage Form: CAPSULE
Applicant: GENEVA PHARMACEUTICALS INC
Active Ingredient(s): FLUOXETINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 074803
Approval Date: 02-AUG-01
Trade Name: FLUOXETINE HCL
Dosage Form: CAPSULE
Applicant: BARR LABORATORIES INC
Active Ingredient(s): FLUOXETINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated and 505(b)(2) New Drug Applications with Tentative Approval

Original Abbreviated Application #: 075810
Tentative Approval Date: 31-AUG-01
Trade Name: FLUOXETINE HCL
Dosage Form: TABLET
Applicant: BARR LABORATORIES INC
Active Ingredient(s): FLUOXETINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application #: 075773
Tentative Approval Date: 24-AUG-01
Trade Name: PAMIDRONATE DISODIUM
Dosage Form: INJECTABLE
Applicant: AMERICAN PHARMACEUTICAL PARTNERS INC
Active Ingredient(s): PAMIDRONATE DISODIUM
OTC/RX Status: RX

Original Abbreviated Application #: 075761
Tentative Approval Date: 23-AUG-01
Trade Name: AMIODARONE HCL
Dosage Form: INJECTABLE
Applicant: AMERICAN PHARMACEUTICAL PARTNERS INC
Active Ingredient(s): AMIODARONE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application #: 076030
Tentative Approval Date: 20-AUG-01
Trade Name: FLECAINIDE ACETATE
Dosage Form: TABLET
Applicant: GENEVA PHARMACEUTICALS TECHNOLOGY CORP
Active Ingredient(s): FLECAINIDE ACETATE
OTC/RX Status: RX

Original Abbreviated Application #: 075903
Tentative Approval Date: 14-AUG-01
Trade Name: LISINOPRIL
Dosage Form: TABLET
Applicant: GENEVA PHARMACEUTICALS TECHNOLOGY CORP
Active Ingredient(s): LISINOPRIL
OTC/RX Status: RX

Original Abbreviated Application #: 075022
Tentative Approval Date: 03-AUG-01
Trade Name: BUSPIRONE HYDROCHLORIDE
Dosage Form: TABLET
Applicant: TEVA PHARMACEUTICALS USA
Active Ingredient(s): BUSPIRONE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application #: 075852
Tentative Approval Date: 02-AUG-01
Trade Name: MILRINONE LACTATE
Dosage Form: INJECTABLE
Applicant: BAXTER HEALTHCARE CORP
Active Ingredient(s): MILRINONE LACTATE
OTC/RX Status: RX

Labeling Supplements to Original New Drug Applications

Application #: 016126 Labeling Supplement#: 025
To Original New Drug Application
Approval Date: 30-AUG-01
Trade Name: PRIMATENE MIST
Dosage Form: AEROSOL, METERED
Applicant: WHITEHALL ROBINS HEALTHCARE DIV AMERICAN HOME PRODUCTS CORP
Active Ingredient(s): EPINEPHRINE
OTC/RX Status: OTC

Application #: 019758 Labeling Supplement#: 044
To Original New Drug Application
Approval Date: 29-AUG-01
Trade Name: CLOZARIL
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): CLOZAPINE
OTC/RX Status: RX

Application #: 018960 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 29-AUG-01
Trade Name: CUPRIC CHLORIDE
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES HOSP PRODUCTS DIV
Active Ingredient(s): CUPRIC CHLORIDE
OTC/RX Status: RX

Application #: 019430 Labeling Supplement#: 012
To Original New Drug Application
Approval Date: 27-AUG-01
Trade Name: EPIPEN
Dosage Form: INJECTABLE
Applicant: MERIDIAN MEDICAL TECHNOLOGIES INC
Active Ingredient(s): EPINEPHRINE
OTC/RX Status: RX

Application #: 019050 Labeling Supplement#: 025
To Original New Drug Application
Approval Date: 27-AUG-01
Trade Name: SUFENTA
Dosage Form: INJECTABLE
Applicant: AKORN INC
Active Ingredient(s): SUFENTANIL CITRATE
OTC/RX Status: RX

Application #: 020387 Labeling Supplement#: 022
To Original New Drug Application
Approval Date: 24-AUG-01
Trade Name: HYZAAR
Dosage Form: TABLET
Applicant: MERCK AND CO INC
Active Ingredient(s): LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX

Application #: 020386 Labeling Supplement#: 026
To Original New Drug Application
Approval Date: 24-AUG-01
Trade Name: COZAAR
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): LOSARTAN POTASSIUM
OTC/RX Status: RX

Application #: 018876 Labeling Supplement#: 024
To Original New Drug Application
Approval Date: 24-AUG-01
Trade Name: POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3%
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): DEXTROSE; SODIUM CHLORIDE; POTASSIUM CHLORIDE
OTC/RX Status: RX

Application #: 018365 Labeling Supplement#: 070
To Original New Drug Application
Approval Date: 24-AUG-01
Trade Name: POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225%
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): DEXTROSE; SODIUM CHLORIDE; POTASSIUM CHLORIDE
OTC/RX Status: RX

Application #: 018680 Labeling Supplement#: 055
To Original New Drug Application
Approval Date: 24-AUG-01
Trade Name: PARAGARD T380A
Dosage Form: INTRAUTERINE DEVICE
Applicant: R.W. JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): COPPER
OTC/RX Status: RX

Application #:018612 Labeling Supplement#: 026
To Original New Drug Application
Approval Date: 24-AUG-01
Trade Name: NICORETTE
Dosage Form: GUM, CHEWING
Applicant: SMITHKLINE BEECHAM CONSUMER HEALTHCARE LP
Active Ingredient(s): NICOTINE POLACRILEX
OTC/RX Status: RX

Application #: 014879 Labeling Supplement#: 036
To Original New Drug Application
Approval Date: 23-AUG-01
Trade Name: DOPRAM
Dosage Form: INJECTABLE
Applicant: WYETH-AYERST RESEARCH
Active Ingredient(s): DOXAPRAM HYDROCHLORIDE
OTC/RX Status: RX

Application #: 019892 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 22-AUG-01
Trade Name: DILAUDID
Dosage Form: TABLET
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): HYDROMORPHONE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 019891 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 22-AUG-01
Trade Name: DILAUDID
Dosage Form: SOLUTION
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): HYDROMORPHONE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020945 Labeling Supplement#: 005
To Original New Drug Application
Approval Date: 21-AUG-01
Trade Name: NORVIR
Dosage Form: CAPSULE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): RITONAVIR
OTC/RX Status: RX

Application #: 020659 Labeling Supplement#: 025
To Original New Drug Application
Approval Date: 21-AUG-01
Trade Name: NORVIR
Dosage Form: SOLUTION
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): RITONAVIR
OTC/RX Status: RX

Application #: 18609 Labeling Supplement#: 035
To Original New Drug Application
Approval Date: 21-AUG-01
Trade Name: HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9%
Dosage Form: INJECTABLE
Applicant: BAXTER HEALTHCARE CORP
Active Ingredient(s): HEPARIN SODIUM
OTC/RX Status: RX

Application #: 018609 Labeling Supplement#: 033
To Original New Drug Application
Approval Date: 21-AUG-01
Trade Name: HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9%
Dosage Form: INJECTABLE
Applicant: BAXTER HEALTHCARE CORP
Active Ingredient(s): HEPARIN SODIUM
OTC/RX Status: RX

Application #: 021062 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 20-AUG-01
Trade Name: TEQUIN
Dosage Form: INJECTABLE
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): GATIFLOXACIN
OTC/RX Status: RX

Application #: 021062 Labeling Supplement#: 006
To Original New Drug Application
Approval Date: 20-AUG-01
Trade Name: TEQUIN
Dosage Form: INJECTABLE
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): GATIFLOXACIN
OTC/RX Status: RX

Application #: 021061 Labeling Supplement#: 006
To Original New Drug Application
Approval Date: 20-AUG-01
Trade Name: TEQUIN
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): GATIFLOXACIN
OTC/RX Status: RX

Application #: 021061 Labeling Supplement#: 005
To Original New Drug Application
Approval Date: 20-AUG-01
Trade Name: TEQUIN
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): GATIFLOXACIN
OTC/RX Status: RX

Application #: 007073 Labeling Supplement#: 115
To Original New Drug Application
Approval Date: 17-AUG-01
Trade Name: AZULFIDINE EN
Dosage Form: TABLET, DELAYED RELEASE
Applicant: PHARMACIA & UPJOHN COMPANY
Active Ingredient(s): SULFASALAZINE
OTC/RX Status: RX

Application #: 012796 Labeling Supplement#: 049
To Original New Drug Application
Approval Date: 16-AUG-01
Trade Name: QUINIDEX
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: AH ROBINS CO
Active Ingredient(s): QUINIDINE SULFATE
OTC/RX Status: RX

Application #: 020973 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 15-AUG-01
Trade Name: ACIPHEX
Dosage Form: TABLET, EXTENDE RELEASE
Applicant: EISAI INC
Active Ingredient(s): RABEPRAZOLE SODIUM
OTC/RX Status: RX

Application #: 020281 Labeling SupplemenT#: 029
To Original New Drug Application
Approval Date: 15-AUG-01
Trade Name: ULTRAM
Dosage Form: TABLET
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): TRAMADOL HYDROCHLORIDE
OTC/RX Status: RX

Application #: 018947 Labeling Supplement#: 014
To Original New Drug Application
Approval Date: 15-AUG-01
Trade Name: SODIUM LACTATE IN PLASTIC CONTAINER
Dosage Form: INJECTION
Applicant: ABBOTT LABORATORIES HOSP PRODUCTS DIV
Active Ingredient(s): SODIUM LACTATE
OTC/RX Status: RX

Application #: 020450 Labeling Supplement#: 005
To Original New Drug Application
Approval Date: 13-AUG-01
Trade Name: CEREBYX
Dosage Form: INJECTABLE
Applicant: PARKE DAVIS DIV WARNER LAMBERT CO
Active Ingredient(s): FOSPHENYTOIN SODIUM
OTC/RX Status: RX

Application #: 020450 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 13-AUG-01
Trade Name: CEREBYX
Dosage Form: INJECTABLE
Applicant: PARKE DAVIS DIV WARNER LAMBERT CO
Active Ingredient(s): FOSPHENYTOIN SODIUM
OTC/RX Status: RX

Application #: 020367 Labeling Supplement#: 049
To Original New Drug Application
Approval Date: 13-AUG-01
Trade Name: CEREZYME
Dosage Form: INJECTABLE
Applicant: GENZYME CORP
Active Ingredient(s): IMIGLUCERASE
OTC/RX Status: RX

Application #: 020367 Labeling Supplement#: 042
To Original New Drug Application
Approval Date: 13-AUG-01
Trade Name: CEREZYME
Dosage Form: INJECTABLE
Applicant: GENZYME CORP
Active Ingredient(s): IMIGLUCERASE
OTC/RX Status: RX

Application #: 020367 Labeling Supplement#: 041
To Original New Drug Application
Approval Date: 13-AUG-01
Trade Name: CEREZYME
Dosage Form: INJECTABLE
Applicant: GENZYME CORP
Active Ingredient(s): IMIGLUCERASE
OTC/RX Status: RX

Application #: 020884 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 10-AUG-01
Trade Name: AGGRENOX
Dosage Form: CAPSULE, EXTENDED RELEASE
Applicant: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Active Ingredient(s): DIPYRIDAMOLE; ASPIRIN
OTC/RX Status: RX

Application #: 019532 Labeling Supplement#: 012
To Original New Drug Application
Approval Date: 10-AUG-01
Trade Name: MYKROX
Dosage Form: TABLET
Applicant: CELLTECH PHARMACEUTICALS INC
Active Ingredient(s): METOLAZONE
OTC/RX Status: RX

Application #: 017386 Labeling Supplement#: 032
To Original New Drug Application
Approval Date: 10-AUG-01
Trade Name: ZAROXOLYN
Dosage Form: TABLET
Applicant: CELLTECH PHARMACEUTICALS INC
Active Ingredient(s): METOLAZONE
OTC/RX Status: RX

Application #: 020676 Labeling Supplement #: 004
To Original New Drug Application
Approval Date: 09-AUG-01
Trade Name:1-DAY
Dosage Form: OINTMENT
Applicant: BRISTOL MYERS SQUIBB CO
Active Ingredient(s): TIOCONAZOLE
OTC/RX Status: OTC

Application #: 020478 Labeling Supplement #: 010
To Original New Drug Application
Approval Date: 09-AUG-01
Trade Name: ULTANE
Dosage Form: LIQUID
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): SEVOFLURANE
OTC/RX Status: RX

Application #: 020597 Labeling Supplement #: 019
To Original New Drug Application
Approval Date: 08-AUG-01
Trade Name: XALATAN
Dosage Form: SOLUTION, DROPS
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): LATANOPROST
OTC/RX Status: RX

Application #: 019778 Labeling Supplement #: 030
To Original New Drug Application
Approval Date: 07-AUG-01
Trade Name: PRINZIDE
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): LISINOPRIL; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX

Application #: 019558 Labeling Supplement #: 038
To Original New Drug Application
Approval Date: 07-AUG-01
Trade Name: PRINIVIL
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): LISINOPRIL
OTC/RX Status: RX

Application #: 018422 Labeling Supplement #: 041
To Original New Drug Application
Approval Date: 07-AUG-01
Trade Name: LOPID
Dosage Form: TABLET
Applicant:PFIZER INC
Active Ingredient(s): GEMFIBROZIL
OTC/RX Status: RX

Application #: 018422 Labeling Supplement #: 040
To Original New Drug Application
Approval Date: 07-AUG-01
Trade Name: LOPID
Dosage Form: TABLET
Applicant:PFIZER INC
Active Ingredient(s): GEMFIBROZIL
OTC/RX Status: RX

Application #: 020263 Labeling Supplement #: 017
To Original New Drug Application
Approval Date: 06-AUG-01
Trade Name: LUPRON
Dosage Form: INJECTABLE
Applicant: TAP PHARMACEUTICAL PRODUCTS INC
Active Ingredient(s): LEUPROLIDE ACETATE
OTC/RX Status: RX

Application #: 016033 Labeling Supplement #: 011
To Original New Drug Application
Approval Date: 06-AUG-01
Trade Name: VONTROL
Dosage Form: TABLET
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): DIPHENIDOL HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020830 Labeling Supplement#: 014
To Original New Drug Application
Approval Date: 02-AUG-01
Trade Name: SINGULAIR
Dosage Form: TABLET
Applicant: MERCK AND CO INC
Active Ingredient(s): MONTELUKAST SODIUM
OTC/RX Status: RX

Application #: 020829 Labeling Supplement#: 012
To Original New Drug Application
Approval Date: 02-AUG-01
Trade Name: SINGULAIR
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): MONTELUKAST SODIUM
OTC/RX Status: RX

Application #: 020890 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 01-AUG-01
Trade Name: LOTRIMIN AF
Dosage Form: SOLUTION
Applicant: SCHERING PLOUGH HEALTHCARE PRODUCTS INC
Active Ingredient(s): CLOTRIMAZOLE
OTC/RX Status: OTC

Application #: 020889 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 01-AUG-01
Trade Name: LOTRIMIN AF
Dosage Form: LOTION
Applicant: SCHERING PLOUGH HEALTHCARE PRODUCTS INC
Active Ingredient(s): CLOTRIMAZOLE
OTC/RX Status: OTC

Application #: 020888 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 01-AUG-01
Trade Name: LOTRIMIN AF
Dosage Form: EMULSION, CREAM
Applicant: SCHERING PLOUGH HEALTHCARE PRODUCTS INC
Active Ingredient(s): CLOTRIMAZOLE
OTC/RX Status: OTC