Drug Approvals for April 2000

Definitions and Notes

Original New Drug Applications

Original Application #: 021025
Approval Date: 21-APR-00
Trade Name: EXELON
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: SOLUTION
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): RIVASTIGMINE TARTRATE
OTC/RX Status: RX
Indication(s): For the treatment of mild to moderate dementia of the Ahzheimer’s type

Original Application #: 020823
Approval Date: 21-APR-00
Trade Name: EXELON
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: CAPSULE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): RIVASTIGMINE TARTRATE
OTC/RX Status: RX
Indication(s): For the treatment of mild to moderate dementia of the Ahzheimer’s type

Original Application #: 021081
Approval Date: 20-APR-00
Trade Name: LANTUS
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: AVENTIS PHARMACEUTICALS INC
Active Ingredient(s): INSULIN GLARGINE
OTC/RX Status: RX
Indication(s): For once-daily subcutaneous administration in the treatment of adult and pediatric patients with type 1 diabetes mellitus or adult patients with type 2 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia

Original Application #: 020938
Approval Date: 13-APR-00
Trade Name: MOBIC
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Active Ingredient(s): MELOXICAM
OTC/RX Status: RX
Indication(s): For relief of the signs and symptoms of osteoarthritis

Original Application #: 021143
Approval Date: 12-APR-00
Trade Name: TRIVAGIZOLE 3
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: VAGINAL CREAM
Applicant: TARO PHARMACEUTICALS USA INC
Active Ingredient(s): CLOTRIMAZOLE
OTC/RX Status: OTC
Indication(s): For the treatment of vaginal yeast infections

Original Application #: 021119
Approval Date: 12-APR-00
Trade Name: VISUDYNE
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: INJECATABLE
Applicant: QLT PHOTO THERAPEUTICS INC
Active Ingredient(s): VERTEPORFIN
OTC/RX Status: RX
Indication(s): For the treatment of age-related macular degeneration in patients with predominantly classic subfoveal choroidal neovascularization

Original Application #: 021103
Approval Date: 11-APR-00
Trade Name: ACTIVELLA
Chemical Type: 6
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: NOVO NORDISK PHARMACEUTICAL INC
Active Ingredient(s): ESTRADIOL; NORETHINDRONE
OTC/RX Status: RX
Indication(s): For women with an intact uterus for the prevention of postmenopausal osteoporosis

Original Application #: 021037
Approval Date: 10-MAR-00
Trade Name: MAGNEVIST
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: BERLEX LABORATORIES INC
Active Ingredient(s): GADOPENTETATE DIMEGLUMINE
OTC/RX Status: RX
Indication(s): Provides for a new, multiple use Pharmacy Bulk Package

Original Application #: 021027
Approval Date: 06-APR-00
Trade Name: HECTOROL
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: BONE CARE INTERNATIONAL INC
Active Ingredient(s): DOXERCALCIFEROL
OTC/RX Status: RX
Indication(s): For the reduction of elevated iPTH levels in the management of secondary hyperparathyroidism in patients undergoing chronic renal dialysis

Efficacy Supplemental New Drug Applications

Application #: 019766 Efficacy Supplement#: 040
Type: SE2 to Original New Drug Application
Approval Date: 27-APR-00
Trade Name: ZOCOR
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): SIMVASTATIN
OTC/RX Status: RX
Efficacy Claim: To reduce elevated total-C, LDL-C, Apo B, and TG, and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson types Iia and IIb)

Application #: 021036 Efficacy Supplement#: 001
Type: SE1 to Original New Drug Application
Approval Date: 26-APR-00
Trade Name: RELENZA
Dosage Form: POWDER, FOR INHALATION
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ZANAMIVIR
OTC/RX Status: RX
Efficacy Claim: for the treatment of uncomplicated acute illness due to influenza A and B in pediatric pateints 7 years and older who have been symptomatic for no more than 2 days

Application #:019304Efficacy Supplement#:005
Type: SE1 to Original New Drug Application
Approval Date: 24-APR-00
Trade Name: TRICOR
Dosage Form: CAPSULE
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): FENOFIBRATE
OTC/RX Status: RX
Efficacy Claim: To treat patients with Frederickson Type Iia and Iib hyperlipoproteinemia

Application #: 020571 Efficacy Supplement#: 009
Type: SE1 to Original New Drug Application
Approval Date: 20-APR-00
Trade Name: CAMPTOSAR
Dosage Form: INJECTABLE
Applicant:PHARMACIA AND UPJOHN
Active Ingredient(s): IRINOTECAN HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim: Provides for the use of Camptosar as a component of first-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic carcinoma of the colon or rectum

Application #: 020444 Efficacy Supplement#: 003
Type: SE1 to Original New Drug Application
Approval Date: 14-APR-00
Trade Name: FLOLAN
Dosage Form: INJECTABLE
Applicant:GLAXO WELLCOME, INC
Active Ingredient(s): EPOPROSTENOL SODIUM
OTC/RX Status: RX
Efficacy Claim: For the long-term intravenous treatment of pulmonary hypertension associated with the scleroderma spectrum of disease NYHA Class III and Class IV patients who do not respond adequately to conventional therapy

Application #: 020563 Efficacy Supplement#: 010
Type: SE2 to Original New Drug Application
Approval Date: 04-APR-00
Trade Name: HUMALOG
Dosage Form: INJECTABLE
Applicant: ELI LILLY AND CO
Active Ingredient(s): INSULIN LISPRO
OTC/RX Status: RX
Efficacy Claim: For the treatment of patients with diabetes mellitus for the control of hyperglycemia

Application #: 021071 Efficacy Supplement #: 001
Type: SE1 to Original New Drug Application
Approval Date: 03-APR-00
Trade Name: AVANDIA
Dosage Form: TABLET
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): ROSIGLITAZONE MALEATE
OTC/RX Status: RX
Efficacy Claim: For use in combination with a sulfonylurea in patients with type 2 diabetes mellitus when diet and exercise with either single agent does not achieve adequate glycemic control.

Approvable Original New Drug Applications

Original Abbreviated New Drug Applications

Original Abbreviated Application # 074657
Approval Date: 28-APR-00
Trade Name: TERAZOSIN HCL
Dosage Form: TABLET
Applicant: INVAMED INC
Active Ingredient(s): TERAZOSIN HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Antibiotic Application# 065041
Approval Date: 28-APR-00
Trade Name: DOXYCYCLINE
Dosage Form: CAPSULE
Applicant: HALSEY DRUG CO INC
Active Ingredient(s): DOXYCYCLINE
OTC/RX Status: RX

Original Abbreviated Application # 040248
Approval Date: 28-APR-00
Trade Name: HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Dosage Form: TABLET
Applicant: UCB PHARMA INC
Active Ingredient(s): HYDROCODONE BITARTRATE; ACETAMINOPHEN
OTC/RX Status: RX

Original Abbreviated Application # 075731
Approval Date: 27-APR-00
Trade Name: CLORAZEPATE DIPOTASSIUM
Dosage Form: TABLET
Applicant: TARO PHARMACEUTICAL INDUSTRIES LTD
Active Ingredient(s): CLORAZEPATE DIPOTASSIUM
OTC/RX Status: RX

Original Abbreviated Application # 075309
Approval Date: 26-APR-00
Trade Name: TICLOPIDINE HYDROCHLORIDE
Dosage Form: TABLET
Applicant: DANBURY PHARMACAL INC
Active Ingredient(s): TICLOPIDINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075581
Approval Date: 25-APR-00
Trade Name: KETOCONAZOLE
Dosage Form: CREAM
Applicant: TEVA PHARMACEUTICALS USA INC
Active Ingredient(s): KETOCONAZOLE
OTC/RX Status: RX

Original Abbreviated Application # 075151
Approval Date: 25-APR-00
Trade Name: MAGNESIUM SULFATE
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): MAGNESIUM SULFATE
OTC/RX Status: RX

Original Abbreviated Application # 040347
Approval Date: 25-APR-00
Trade Name: LEUCOVORIN CALCIUM
Dosage Form: INJECTABLE
Applicant: BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
Active Ingredient(s): LEUCOVORIN CALCIUM
OTC/RX Status: RX

Original Abbreviated Application # 075508
Approval Date: 24-APR-00
Trade Name: DIFLORASONE DIACETATE
Dosage Form: CREAM
Applicant: TARO PHARMACEUTICALS INC
Active Ingredient(s): DIFLORASONE DIACETATE
OTC/RX Status: RX

Original Abbreviated Application # 074530
Approval Date: 21-APR-00
Trade Name: TERAZOSIN HYDROCHLORIDE
Dosage Form: TABLET
Applicant: ZENITH GOLDLINE PHARMACEUTICALS, INC
Active Ingredient(s): TERAZOSIN HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075437
Approval Date: 21-APR-00
Trade Name: CROMOLYN SODIUM
Dosage Form: SOLUTION
Applicant: WARRICK PHARMACEUTICALS
Active Ingredient(s): CROMOLYN SODIUM
OTC/RX Status: RX

Original Abbreviated Application # 075323
Approval Date: 21-APR-00
Trade Name: PLEGISOL
Dosage Form: INJECTABLE
Applicant: BAXTER HEALTHCARE CORP
Active Ingredient(s): SODIUM CHLORIDE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 040335
Approval Date: 20-APR-00
Trade Name: LEUCOVORIN CALCIUM
Dosage Form: INJECTABLE
Applicant: BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
Active Ingredient(s): LEUCOVORIN CALCIUM
OTC/RX Status: RX

Original Abbreviated Application # 075439
Approval Date: 19-APR-00
Trade Name: RANITIDINE
Dosage Form: TABLET
Applicant: RANBAXY LABORATORIES LTD
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075328
Approval Date: 19-APR-00
Trade Name: PEMOLINE
Dosage Form: TABLET
Applicant: VINTAGE PHARMACEUTICALS INC
Active Ingredient(s): PEMOLINE
OTC/RX Status: RX

Original Abbreviated Application # 075491
Approval Date: 17-APR-00
Trade Name: BUPROPION HCL
Dosage Form: TABLET
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): BUPROPION HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075387
Approval Date: 06-APR-00
Trade Name: FLOXURIDINE
Dosage Form: INJECTABLE
Applicant: BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
Active Ingredient(s): FLOXURIDINE
OTC/RX Status: RX

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

Original Abbreviated Application #: 075636
Tentative Approval Date: 28-APR-00
Trade Name: LOVASTATIN
Dosage Form: TABLET
Applicant: EON LABORATORIES MANUFACTURING INC
Active Ingredient(s): LOVASTATIN
OTC/RX Status: RX

Original Abbreviated Application #: 075457
Tentative Approval Date: 26-APR-00
Trade Name: FAMOTIDINE
Dosage Form: TABLET
Applicant: GENPHARM INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX

Original Abbreviated Application #: 074690
Tentative Approval Date: 26-APR-00
Trade Name: NORFLOXACIN
Dosage Form: TABLET
Applicant: NOVOPHARM LTD
Active Ingredient(s): NORFLOXACIN
OTC/RX Status: RX

Original Abbreviated Application #: 075510
Tentative Approval Date: 25-APR-00
Trade Name: MILRINONE LACTATE IN DEXTROSE 5%
Dosage Form: INJECTABLE
Applicant: ESI LEDERLE INC
Active Ingredient(s): MILRINONE LACTATE
OTC/RX Status: RX

Original Abbreviated Application #: 075386
Tentative Approval Date: 25-APR-00
Trade Name: BETAXOLOL OPHTHALMIC SOLUTION
Dosage Form: SOLUTION
Applicant: AKORN, INC
Active Ingredient(s): BETAXOLOL
OTC/RX Status: RX

Original Abbreviated Application #: 075154
Tentative Approval Date: 20-APR-00
Trade Name: MIDAZOLAM HYDROCHLORIDE
Dosage Form: INJECTABLE
Applicant: AESGEN INC
Active Ingredient(s): MIDAZOLAM HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application #: 075630
Tentative Approval Date: 19-APR-00
Trade Name: BETAXOLOL
Dosage Form: SOLUTION
Applicant: BAUSCH AND LOMB PHARMACEUTICALS INC
Active Ingredient(s): BETAXOLOL
OTC/RX Status: RX

Labeling Supplements to Original New Drug Applications

Application #: 018687 Labeling Supplement#: 021
To Original New Drug Application
Approval Date: 25-APR-00
Trade Name: NORMODYNE
Dosage Form: TABLET
Applicant: SCHERING CORP SUB SCHERING PLOUGH CORP
Active Ingredient(s): LABETALOL HYDROCHLORIDE
OTC/RX Status: RX

Application #: 018686 Labeling Supplement#: 026
To Original New Drug Application
Approval Date: 25-APR-00
Trade Name: NORMODYNE
Dosage Form: INJECTABLE
Applicant: SCHERING CORP SUB SCHERING PLOUGH CORP
Active Ingredient(s): LABETALOL HYDROCHLORIDE
OTC/RX Status: RX

Application #: 021039 Labeling Supplement#: 003
To Original New Drug Application
Approval Date: 24-APR-00
Trade Name: AGENERASE
Dosage Form: SOLUTION
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): AMPRENAVIR
OTC/RX Status: RX

Application #: 021007 Labeling Supplement#: 003
To Original New Drug Application
Approval Date: 24-APR-00
Trade Name: AGENERASE
Dosage Form: CAPSULE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): AMPRENAVIR
OTC/RX Status: RX

Application #: 007073 Labeling Supplement#: 109
To Original New Drug Application
Approval Date: 24-APR-00
Trade Name: AZULFIDINE
Dosage Form: TABLET
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): SULFASALAZINE
OTC/RX Status: RX

Application #: 021065 Labeling Supplement#: 003
To Original New Drug Application
Approval Date: 20-APR-00
Trade Name: FEMHRT
Dosage Form: TABLET
Applicant: PARKE DAVIS
Active Ingredient(s): NORETHINDRONE ACETATE; ETHINYL ESTRADIOL
OTC/RX Status: RX

Application #: 020978 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 20-APR-00
Trade Name: ZIAGEN
Dosage Form: SOLUTION
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ABACAVIR SULFATE
OTC/RX Status: RX

Application #: 020977 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 20-APR-00
Trade Name: ZIAGEN
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ABACAVIR SULFATE
OTC/RX Status: RX

Application #: 019941 Labeling Supplement#: 012
To Original New Drug Application
Approval Date: 20-APR-00
Trade Name: EMLA
Dosage Form: CREAM
Applicant: ASTRAZENECA LP
Active Ingredient(s): LIDOCAINE; PRILOCAINE
OTC/RX Status: RX

Application #: 020962 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 20-APR-00
Trade Name: EMLA
Dosage Form: DISC
Applicant: ASTRAZENECA LP
Active Ingredient(s): LIDOCAINE; PRILOCAINE
OTC/RX Status: RX

Application #: 020199 Labeling Supplement#: 012
To Original New Drug Application
Approval Date: 19-APR-00
Trade Name: HIVID
Dosage Form: TABLET
Applicant: HOFFMANN LA ROCHE INC
Active Ingredient(s): ZALCITABINE
OTC/RX Status: RX

Application #: 007073 Labeling Supplement#: 113
To Original New Drug Application
Approval Date: 18-APR-00
Trade Name: AZULFIDINE
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): SULFASALAZINE
OTC/RX Status: RX

Application #: 020655 Labeling Supplement#: 005
To Original New Drug Application
Approval Date: 14-APR-00
Trade Name: ALORA
Dosage Form: FILM, EXTENDED RELEASE
Applicant: WATSON LABORATORIES INC
Active Ingredient(s): ESTRADIOL
OTC/RX Status: RX

Application #: 020411 Labeling Supplement#: 016
To Original New Drug Application
Approval Date: 13-APR-00
Trade Name: CERVIDIL
Dosage Form: INSERT, EXTENDED RELEASE
Applicant: FOREST LABORATORIES INC
Active Ingredient(s): DINOPROSTONE
OTC/RX Status: RX

Application #: 050705 Labeling Supplement#: 003
To Original New Drug Application
Approval Date: 12-APR-00
Trade Name: RIFATER
Dosage Form: TABLET
Applicant: AVENTIS PHARMACEUTICALS INC
Active Ingredient(s): ISONIAZID; PYRAZINAMIDE; RIFAMPIN
OTC/RX Status: RX

Application #: 050627 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 12-APR-00
Trade Name: RIFADIN
Dosage Form: INJECTABLE
Applicant: AVENTIS PHARMACEUTICALS INC
Active Ingredient(s): RIFAMPIN
OTC/RX Status: RX

Application #: 050627 Labeling Supplement#: 006
To Original New Drug Application
Approval Date: 12-APR-00
Trade Name: RIFADIN
Dosage Form: INJECTABLE
Applicant: AVENTIS PHARMACEUTICALS INC
Active Ingredient(s): RIFAMPIN
OTC/RX Status: RX

Application #: 050420 Labeling Supplement#: 071
To Original New Drug Application
Approval Date: 12-APR-00
Trade Name: RIFADIN
Dosage Form: CAPSULE
Applicant: AVENTIS PHARMACEUTICALS INC
Active Ingredient(s): RIFAMPIN
OTC/RX Status: RX

Application #: 050420 Labeling Supplement#: 070
To Original New Drug Application
Approval Date: 12-APR-00
Trade Name: RIFADIN
Dosage Form: CAPSULE
Applicant: AVENTIS PHARMACEUTICALS INC
Active Ingredient(s): RIFAMPIN
OTC/RX Status: RX

Application #: 018405 Labeling Supplement#: 016
To Original New Drug Application
Approval Date: 12-APR-00
Trade Name: AYGESTIN
Dosage Form: TABLET
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): NORETHINDRONE ACETATE
OTC/RX Status: RX

Application #: 020685 Labeling Supplement#: 042
To Original New Drug Application
Approval Date: 11-APR-00
Trade Name: CRIXIVAN
Dosage Form: CAPSULE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): INDINAVIR SULFATE
OTC/RX Status: RX

Application #: 020685 Labeling Supplement#: 038
To Original New Drug Application
Approval Date: 11-APR-00
Trade Name: CRIXIVAN
Dosage Form: CAPSULE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): INDINAVIR SULFATE
OTC/RX Status: RX

Application #: 020685 Labeling Supplement#: 035
To Original New Drug Application
Approval Date: 11-APR-00
Trade Name: CRIXIVAN
Dosage Form: CAPSULE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): INDINAVIR SULFATE
OTC/RX Status: RX

Application #: 020907 Labeling Supplement#: 003
To Original New Drug Application
Approval Date: 11-APR-00
Trade Name: ACTIVELLA
Dosage Form: TABLET
Applicant: NOVO NORDISK A/S
Active Ingredient(s): ESTRADIOL; NORETHINDRONE ACETATE
OTC/RX Status: RX

Application #: 020403 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 11-APR-00
Trade Name: ZOFRAN
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ONDANSETRON HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020007 Labeling Supplement#: 030
To Original New Drug Application
Approval Date: 11-APR-00
Trade Name: ZOFRAN
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ONDANSETRON HYDROCHLORIDE
OTC/RX Status: RX

Application #: 018163 Labeling Supplement#: 048
To Original New Drug Application
Approval Date: 11-APR-00
Trade Name: RESTORIL
Dosage Form: CAPSULE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): TEMAZEPAM
OTC/RX Status: RX

Application #: 020234 Labeling Supplement#: 014
To Original New Drug Application
Approval Date: 10-APR-00
Trade Name: TEGRETOL-XR
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): CARBAMAZEPINE
OTC/RX Status: RX

Application #: 020234 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 10-APR-00
Trade Name: TEGRETOL-XR
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): CARBAMAZEPINE
OTC/RX Status: RX

Application #: 018927 Labeling Supplement#: 028
To Original New Drug Application
Approval Date: 10-APR-00
Trade Name: TEGRETOL
Dosage Form: SUSPENSION
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): CARBAMAZEPINE
OTC/RX Status: RX

Application #: 018927 Labeling Supplement#: 024
To Original New Drug Application
Approval Date: 10-APR-00
Trade Name: TEGRETOL
Dosage Form: SUSPENSION
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): CARBAMAZEPINE
OTC/RX Status: RX

Application #: 018281 Labeling Supplement#: 037
To Original New Drug Application
Approval Date: 10-APR-00
Trade Name: TEGRETOL
Dosage Form: TABLET, CHEWABLE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): CARBAMAZEPINE
OTC/RX Status: RX

Application #: 018281 Labeling Supplement#: 033
To Original New Drug Application
Approval Date: 10-APR-00
Trade Name: TEGRETOL
Dosage Form: TABLET, CHEWABLE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): CARBAMAZEPINE
OTC/RX Status: RX

Application #: 016608 Labeling Supplement#: 088
To Original New Drug Application
Approval Date: 10-APR-00
Trade Name: TEGRETOL
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): CARBAMAZEPINE
OTC/RX Status: RX

Application #: 016608 Labeling Supplement#: 084
To Original New Drug Application
Approval Date: 10-APR-00
Trade Name: TEGRETOL
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): CARBAMAZEPINE
OTC/RX Status: RX

Application #: 020766 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 06-APR-00
Trade Name: XENICAL
Dosage Form: CAPSULE
Applicant: HOFFMANN LA ROCHE INC
Active Ingredient(s): ORLISTAT
OTC/RX Status: RX

Application #: 020766 Labeling Supplement#: 003
To Original New Drug Application
Approval Date: 06-APR-00
Trade Name: XENICAL
Dosage Form: CAPSULE
Applicant: HOFFMANN LA ROCHE INC
Active Ingredient(s): ORLISTAT
OTC/RX Status: RX

Application #: 020729 Labeling Supplement#: 005
To Original New Drug Application
Approval Date: 05-APR-00
Trade Name: UNIRETIC
Dosage Form: TABLET
Applicant: SCHWARZ PHARMA INC
Active Ingredient(s): MOEXIPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX

Application #: 020528 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 05-APR-00
Trade Name: MAVIK
Dosage Form: TABLET
Applicant: KNOLL PHARMACEUTICAL CO SUB BASF CORP
Active Ingredient(s): TRANDOLAPRIL
OTC/RX Status: RX

Application #: 020401 Labeling Supplement#: 015
To Original New Drug Application
Approval Date: 05-APR-00
Trade Name: TIAZAC
Dosage Form: CAPSULE, EXTENDED RELEASE
Applicant: BIOVAIL LABORATORIES INC
Active Ingredient(s): DILTIAZEM HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020604 Labeling Supplement#: 006
To Original New Drug Application
Approval Date: 04-APR-00
Trade Name: SEROSTIM
Dosage Form: INJECTABLE
Applicant: SERONO LABORATORIES INC
Active Ingredient(s): SOMATROPIN RECOMBINANT
OTC/RX Status: RX

Application #: 020186 Labeling Supplement#: 011
To Original New Drug Application
Approval Date: 04-APR-00
Trade Name: ZIAC
Dosage Form: TABLET
Applicant: LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
Active Ingredient(s): BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX

Application #: 019982 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 04-APR-00
Trade Name: ZEBETA
Dosage Form: TABLET
Applicant: LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
Active Ingredient(s): BISOPROLOL FUMARATE
OTC/RX Status: RX

Application #: 019058 Labeling Supplement#: 012
To Original New Drug Application
Approval Date: 04-APR-00
Trade Name: TENORMIN
Dosage Form: INJECTABLE
Applicant: ASTRAZENECA PHARMACEUTICALS LP
Active Ingredient(s): ATENOLOL
OTC/RX Status: RX

Application #: 018760 Labeling Supplement#: 022
To Original New Drug Application
Approval Date: 04-APR-00
Trade Name: TENORETIC
Dosage Form: TABLET
Applicant: ASTRAZENECA PHARMACEUTICALS LP
Active Ingredient(s): ATENOLOL; CHLORTHALIDONE
OTC/RX Status: RX

Application #: 018240 Labeling Supplement#: 025
To Original New Drug Application
Approval Date: 04-APR-00
Trade Name: TENORMIN
Dosage Form: TABLET
Applicant: ASTRAZENECA PHARMACEUTICALS LP
Active Ingredient(s): ATENOLOL
OTC/RX Status: RX

Application #: 020946 Labeling Supplement #: 005
To Original New Drug Application
Approval Date: 03-APR-00
Trade Name: PREVEN EMERGENCY CONTRACEPTIVE KIT
Dosage Form: TABLET
Applicant: GYNETICS INC
Active Ingredient(s): LEVONORGESTREL; ETHINYL ESTRADIOL
OTC/RX Status: RX

Application #: 018782 Labeling Supplement #: 023
To Original New Drug Application
Approval Date: 03-APR-00
Trade Name: NORDETTE-28
Dosage Form: TABLET
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): ETHINYL ESTRADIOL; LEVONORGESTREL
OTC/RX Status: RX

Application #: 018668 Labeling Supplement #: 030
To Original New Drug Application
Approval Date: 03-APR-00
Trade Name: NORDETTE-21
Dosage Form: TABLET
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): ETHINYL ESTRADIOL; LEVONORGESTREL
OTC/RX Status: RX

Application #: 017802 Labeling Supplement #: 018
To Original New Drug Application
Approval Date: 03-APR-00
Trade Name: LO/OVRAL-28
Dosage Form: TABLET
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): NORGESTREL; ETHINYL ESTRADIOL
OTC/RX Status: RX

Application #: 017612 Labeling Supplement #: 031
To Original New Drug Application
Approval Date: 03-APR-00
Trade Name: LO/OVRAL
Dosage Form: TABLET
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): NORGESTREL; ETHINYL ESTRADIOL
OTC/RX Status: RX