Drug Approvals for January 2000

Definitions and Notes

Original New Drug Applications

Original Application #: 020939
Approval Date: 28-JAN-00
Trade Name: DILTIAZEM HCL
Chemical Type: 5
Therapeutic Potential: S
Dosage Form: CAPSULE, EXTENDED RELEASE
Applicant: BIOVAIL LABORATORIES INC
Active Ingredient(s): DILTIAZEM HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): Treatment of hypertension

Original Application #: 019386
Approval Date: 19-JAN-00
Trade Name: BREVIBLOC
Chemical Type:
Therapeutic Potential:
Dosage Form: INJECTABLE
Applicant: BAXTER PHARMARMACEUTICALS PRODUCTS INC
Active Ingredient(s): ESMOLOL HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): For the reposition of the “Must Be Diluted” warning flag in or to increase its prominence substantially

Original Application #: 021014
Approval Date: 14-JAN-00
Trade Name: TRILEPTAL
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP DBA CIBA PHARMACEUTICALS CO
Active Ingredient(s): OXCARBAZEPINE
OTC/RX Status: RX
Indication(s): For use as monotherapy or adjunctive therapy in the treatment of partial seizures in children ages 4-16 with epilepsy

Original Application #: 020989
Approval Date: 11-JAN-00
Trade Name: EVOXAC
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: CAPSULE
Applicant: SNOWBRAND PHARMACEUTICALS INC
Active Ingredient(s): CEVIMELINE HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): For the treatment of symptoms of dry mouth in patients with Sjorgren’s Syndrome

Original Application #: 020472
Approval Date: 05-JAN-00
Trade Name: ESTRING
Chemical Type:
Therapeutic Potential:
Dosage Form: VAGINAL RING
Applicant: PHARMACIA AND UPJOHN
Active Ingredient(s): ESTRADIOL
OTC/RX Status: RX
Indication(s): For the treatment of urogenital symptoms associated with post-menopausal atrophy of the vagina (such as dryness, burning, pruritus and dyspareunia) and/or the lower urinary tract (urinary urgency and dysuria)

Efficacy Supplemental New Drug Applications

Application #: 019941 Efficacy Supplement#: 011
Type: SE1 to Original New Drug Application
Approval Date: 28-JAN-00
Trade Name: EMLA
Dosage Form: CREAM
Applicant: ASTRAZENECA LP
Active Ingredient(s): LIDOCAINE; PRILOCAINE
OTC/RX Status: RX
Efficacy Claim: For superficial minor surgery of genital mucous membranes and as an adjunct for local infiltration anesthesia in genital mucous membranes

Approvable Original New Drug Applications

Original Application #: 021151
Approvable Date: 24-JAN-00
Trade Name: BETAPACE
Dosage Form: TABLET
Applicant: BERLEX LABORATORIES
Active Ingredient(s): SOTALOL HYDROCHLORIDE OTC/RX Status: RX

Original Application #: 020982
Approvable Date: 03-JAN-00
Trade Name: PAXIL CR
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): PAROXETINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated New Drug Applications

Original Abbreviated Application # 075640
Approval Date: 28-JAN-00
Trade Name: HYDROCHLOROTHIAZIDE
Dosage Form: CAPSULE
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): HYDROCHLOROTHIAZIDE
OTC/RX Status: RX

Original Abbreviated Application # 075407
Approval Date: 28-JAN-00
Trade Name: MORPHINE SULFATE
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: ESI LEDERLE INC
Active Ingredient(s): MORPHINE SULFATE
OTC/RX Status: RX

Original Abbreviated Antibiotic Application# 064160
Approval Date: 28-JAN-00
Trade Name: CLINDAMYCIN PHOSPHATE
Dosage Form: GEL
Applicant: E FOUGERA DIV ALTANA INC
Active Ingredient(s): CLINDAMYCIN PHOSPHATE
OTC/RX Status: RX

Original Abbreviated Application # 075235
Approval Date: 27-JAN-00
Trade Name: METAPROTERENOL SULFATE
Dosage Form: SYRUP
Applicant: NOVEX PHARMA
Active Ingredient(s): METAPROTERENOL SULFATE
OTC/RX Status: RX

Original Abbreviated Application # 040333
Approval Date: 27-JAN-00
Trade Name: FLUOROURACIL
Dosage Form: INJECTABLE
Applicant: GENSIA SICOR PHARMACEUTICALS INC
Active Ingredient(s): FLUOROURACIL
OTC/RX Status: RX

Original Abbreviated Application # 074973
Approval Date: 24-JAN-00
Trade Name: TRIMETHOPRIM HCL
Dosage Form: SOLUTION
Applicant: ASCENT PEDIATRICS INC
Active Ingredient(s): TRIMETHOPRIM HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Antibiotic Application# 065035
Approval Date: 24-JAN-00
Trade Name: DAUNORUBICIN HCL
Dosage Form: INJECTABLE
Applicant: GENSIA SICOR PHARMACEUTICALS INC
Active Ingredient(s): DAUNORUBICIN HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Antibiotic Application# 075546
Approval Date: 20-JAN-00
Trade Name: CARTEOLOL HCL
Dosage Form: SOLUTION
Applicant: BAUSCH AND LOMB PHARMACEUTICALS INC
Active Ingredient(s): CARTEOLOL HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Antibiotic Application# 040322
Approval Date: 19-JAN-00
Trade Name: PREDNISOLONE
Dosage Form: SYRUP
Applicant: COPLEY PHARMACEUTICALS INC
Active Ingredient(s): PREDNISOLONE
OTC/RX Status: RX

Original Abbreviated Antibiotic Application#075271
Approval Date: 18-JAN-00
Trade Name: CROMOLYN SODIUM
Dosage Form: INHALATION
Applicant: ZENITH GOLDLINE PHARMACEUTICAL
Active Ingredient(s): CROMOLYN SODIUM
OTC/RX Status: RX

Original Abbreviated Antibiotic Application#075497
Approval Date: 14-JAN-00
Trade Name: RANITIDINE
Dosage Form: TABLET
Applicant: MYLAN PHARMACEUTICAL
Active Ingredient(s): RANITIDINE
OTC/RX Status: OTC

Original Abbreviated Application # 075296
Approval Date: 14-JAN-00
Trade Name: RANITIDINE
Dosage Form: TABLET
Applicant: ZENITH GOLDLINE PHARMACEUTICALS
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: OTC

Original Abbreviated Antibiotic Application#075254
Approval Date: 14-JAN-00
Trade Name: RANITIDINE
Dosage Form: TABLET
Applicant: MYLAN PHARMACEUTICAL
Active Ingredient(s): RANITIDINE
OTC/RX Status: OTC

Original Abbreviated Application # 075212
Approval Date: 14-JAN-00
Trade Name: RANITIDINE
Dosage Form: TABLET
Applicant: CHELSEA LABORATORIES INC
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: OTC

Original Abbreviated Application # 075132
Approval Date: 14-JAN-00
Trade Name: RANITIDINE
Dosage Form: TABLET
Applicant: RANBAXY LABORATORIES LTD
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: OTC

Original Abbreviated Antibiotic Application#065017
Approval Date: 13-JAN-00
Trade Name: CYCLOSPORINE
Dosage Form: CAPSULE
Applicant: EON LABS MANUFACTURING
Active Ingredient(s): CYCLOSPORINE
OTC/RX Status: RX

Original Abbreviated Application # 075232
Approval Date: 06-JAN-00
Trade Name: LOPERAMIDE HCL
Dosage Form: TABLET
Applicant: PERRIGO CO
Active Ingredient(s): LOPERAMIDE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075476
Approval Date: 03-JAN-00
Trade Name: CARTEOLOL HCL
Dosage Form: SOLUTION
Applicant: ALCON LABORATORIES INC
Active Ingredient(s): CARTEOLOL HYDROCHLORIDE
OTC/RX Status: RX

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

Original Abbreviated Application #: 075571
Tentative Approval Date: 28-JAN-00
Trade Name: ENALAPRILAT
Dosage Form: INJECTABLE
Applicant: FAULDING PHARMACEUTICAL CO
Active Ingredient(s): ENALAPRILAT
OTC/RX Status: RX

Original Abbreviated Application #: 075458
Tentative Approval Date: 24-JAN-00
Trade Name: ENALAPRILAT
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): ENALAPRILAT
OTC/RX Status: RX

Original Abbreviated Application #: 075456
Tentative Approval Date: 24-JAN-00
Trade Name: ENALAPRILAT
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): ENALAPRILAT
OTC/RX Status: RX

Original Abbreviated Application #: 075452
Tentative Approval Date: 03-JAN-00
Trade Name: FLUOXETINE
Dosage Form: CAPSULE
Applicant: TEVA PHARMACEUTICALS USA INC
Active Ingredient(s): FLUOXETINE HYDROCHLORIDE
OTC/RX Status: RX

Labeling Supplements to Original New Drug Applications

Application #: 020387 Labeling Supplement#: 014
To Original New Drug Application
Approval Date: 28-JAN-00
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#: 018
To Original New Drug Application
Approval Date: 28-JAN-00
Trade Name: COZAAR
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): LOSARTAN POTASSIUM
OTC/RX Status: RX

Application #: 018700 Labeling Supplement#: 019
To Original New Drug Application
Approval Date: 28-JAN-00
Trade Name: INOCOR
Dosage Form: INJECTABLE
Applicant: SANOFI SYNTHELABO INC
Active Ingredient(s): AMRINONE LACTATE
OTC/RX Status: RX

Application #: 018977 Labeling Supplement#: 027
To Original New Drug Application
Approval Date: 24-JAN-00
Trade Name: TRI-NORINYL 28-DAY
Dosage Form: TABLET
Applicant: WATSON LABORATORIES INC
Active Ingredient(s): NORETHINDRONE; ETHINYL ESTRADIOL
OTC/RX Status: RX

Application #: 018977 Labeling Supplement#: 027
To Original New Drug Application
Approval Date: 24-JAN-00
Trade Name: TRI-NORINYL 21-DAY
Dosage Form: TABLET
Applicant: WATSON LABORATORIES INC
Active Ingredient(s): NORETHINDRONE; ETHINYL ESTRADIOL
OTC/RX Status: RX

Application #: 017743 Labeling Supplement#: 074
To Original New Drug Application
Approval Date: 24-JAN-00
Trade Name: BREVICON 28-DAY
Dosage Form: TABLET
Applicant: WATSON LABORATORIES INC
Active Ingredient(s): NORETHINDRONE; ETHINYL ESTRADIOL
OTC/RX Status: RX

Application #: 017566 Labeling Supplement#: 084
To Original New Drug Application
Approval Date: 24-JAN-00
Trade Name: BREVICON 21-DAY
Dosage Form: TABLET
Applicant: WATSON LABORATORIES INC
Active Ingredient(s): NORETHINDRONE; ETHINYL ESTRADIOL
OTC/RX Status: RX

Application #: 017565 Labeling Supplement#: 070
To Original New Drug Application
Approval Date: 24-JAN-00
Trade Name: NORINYL 1+35 28-DAY
Dosage Form: TABLET
Applicant: WATSON LABORATORIES INC
Active Ingredient(s): NORETHINDRONE; ETHINYL ESTRADIOL
OTC/RX Status: RX

Application #: 017565 Labeling Supplement#: 070
To Original New Drug Application
Approval Date: 24-JAN-00
Trade Name: NORINYL 1+35 21-DAY
Dosage Form: TABLET
Applicant: WATSON LABORATORIES INC
Active Ingredient(s): NORETHINDRONE; ETHINYL ESTRADIOL
OTC/RX Status: RX

Application #: 016659 Labeling Supplement#: 125
To Original New Drug Application
Approval Date: 24-JAN-00
Trade Name: NORINYL 1+50 28-DAY
Dosage Form: TABLET
Applicant: GD SEARLE AND CO
Active Ingredient(s): NORETHINDRONE; MESTRANOL
OTC/RX Status: RX

Application #: 013625 Labeling Supplement#: 181
To Original New Drug Application
Approval Date: 24-JAN-00
Trade Name: NORINYL-2 21-DAY
Dosage Form: TABLET
Applicant: GD SEARLE AND CO
Active Ingredient(s): NORETHINDRONE; MESTRANOL
OTC/RX Status: RX

Application #: 020869 Labeling Supplement#: 003
To Original New Drug Application
Approval Date: 23-JAN-00
Trade Name: COSOPT
Dosage Form: SOLUTION
Applicant: MERCK & CO
Active Ingredient(s): DORZOLAMIDE HYDROCHLORIDE-TIMOLOL MALEATE
OTC/RX Status: RX

Application #: 020895 Labeling Supplement#: 005
To Original New Drug Application
Approval Date: 21-JAN-00
Trade Name: VIAGRA
Dosage Form: TABLET
Applicant: PFIZER
Active Ingredient(s): SILDENAFIL CITRATE
OTC/RX Status: RX

Application #: 018354 Labeling Supplement#: 038
To Original New Drug Application
Approval Date: 21-JAN-00
Trade Name: ORTHO-NOVUM 10/11 28
Dosage Form: TABLET
Applicant: RW JOHNSON PHARMACUETICAL
Active Ingredient(s): NORETHINDRONE; ETHINYL ESTRADIOL
OTC/RX Status: RX

Application #: 018354 Labeling Supplement#: 038
To Original New Drug Application
Approval Date: 21-JAN-00
Trade Name: ORTHO-NOVUM 10/11 21
Dosage Form: TABLET
Applicant: RW JOHNSON PHARMACUETICAL
Active Ingredient(s): NORETHINDRONE; ETHINYL ESTRADIOL
OTC/RX Status: RX

Application #:020387 Labeling Supplement#: 017  To Original New Drug Application
Approval Date: 19-JAN-00
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#: 020 To Original New Drug Application
Approval Date: 19-JAN-00
Trade Name: COZAAR
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): LOSARTAN POTASSIUM
OTC/RX Status: RX

Application #:020356 Labeling Supplement#: 008 To Original New Drug Application
Approval Date: 19-JAN-00
Trade Name: SULAR
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: ZENECA PHARMACEUTICALS
Active Ingredient(s): NISOLDIPINE
OTC/RX Status: RX

Application #:020356 Labeling Supplement#: 007 To Original New Drug Application
Approval Date: 19-JAN-00
Trade Name: SULAR
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: ZENECA PHARMACEUTICALS
Active Ingredient(s): NISOLDIPINE
OTC/RX Status: RX

Application #:019785 Labeling Supplement#: 013 To Original New Drug Application
Approval Date: 14-JAN-00
Trade Name: CARDIOLITE
Dosage Form: INJECTABLE
Applicant: DUPONT PHARMACEUTICALS CO
Active Ingredient(s): TECHNETIUM TC-99M SESTAMIBI KIT
OTC/RX Status: RX

Application #:020913 Labeling Supplement#: 004 To Original New Drug Application
Approval Date: 11-JAN-00
Trade Name: AGGRASTAT
Dosage Form: INJECTABLE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): TIROFIBAN HYDROCHLORIDE
OTC/RX Status: RX

Application #:020912 Labeling Supplement#:004 To Original New Drug Application
Approval Date: 11-JAN-00
Trade Name: AGGRASTAT
Dosage Form: INJECTABLE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): TIROFIBAN HYDROCHLORIDE
OTC/RX Status: RX

Application #: 20611 Labeling Supplement #: 005
To Original New Drug Application
Approval Date: 11-JAN-00
Trade Name: DOVONEX
Dosage Form: SOLUTION
Applicant: WESTWOOD SQUIBB
Active Ingredient(s): CALCIPOTRIENE SOLUTION
OTC/RX Status: RX

Application #:020527 Labeling Supplement#:015 To Original New Drug Application
Approval Date: 06-JAN-00
Trade Name: PREMPRO 14/14
Dosage Form: TABLET
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE
OTC/RX Status: RX

Application #:020527 Labeling Supplement#:015 To Original New Drug Application
Approval Date: 06-JAN-00
Trade Name: PREMPHASE 14/14
Dosage Form: TABLET
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE
OTC/RX Status: RX

Application #:020539 Labeling Supplement#:003 To Original New Drug Application
Approval Date: 05-JAN-00
Trade Name: LAMISIL
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS
Active Ingredient(s): TERBINAFINE HYDROCHLORIDE
OTC/RX Status: RX