Drug Approvals for May 2000

Definitions and Notes

Original New Drug Applications

Original Application #: 021134
Approval Date: 01-MAY-00
Trade Name: NITROSTAT
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: PARKE DAVIS PHARMACEUTICALS LTD
Active Ingredient(s): NITROGLYCERIN
OTC/RX Status: RX
Indication(s): For the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease

Efficacy Supplemental New Drug Applications

Application #: 020164 Efficacy Supplement#: 034
Type: SE8 to Original New Drug Application
Approval Date: 30-MAY-00
Trade Name: LOVENOX
Dosage Form: INJECTABLE
Applicant: AVENTIS PHARMACEUTICAL PRODUCTS INC
Active Ingredient(s): ENOXAPARIN SODIUM
OTC/RX Status: RX
Efficacy Claim: Provides for changes in labeling for Geriatric use

Application #: 020114 Efficacy Supplement#: 005
Type: SE1 to Original New Drug Application
Approval Date: 30-MAY-00
Trade Name: ASTELIN
Dosage Form: SPRAY, METERED
Applicant: WALLACE LABORATORIES DIV CARTER WALLACE INC
Active Ingredient(s): AZELASTINE HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim: For the treatment of the symptoms of seasonal allergic rhinitis such as rhinorrhea, sneezing, and nasal pruritus in adults and children 5 years and older

Application #: 020378 Efficacy Supplement#: 006
Type: SE1 to Original New Drug Application
Approval Date: 24-MAY-00
Trade Name: GONAL-F
Dosage Form: INJECTABLE
Applicant: SERONO LABORATORIES INC
Active Ingredient(s): FOLLITROPIN ALFA/BETA
OTC/RX Status: RX
Efficacy Claim: For the induction of spermatogenesis in men with primary and secondary hopygonadotropic hypogonadism in whom the cause of infertility is not due to primary testicular failure

Approvable Original New Drug Applications

Original Abbreviated New Drug Applications

Original Abbreviated Application # 075542
Approval Date: 10-MAY-00
Trade Name: AMRINONE LACTATE
Dosage Form: INJECTABLE
Applicant: BAXTER PHARMACEUTICAL PRODUCTS INC
Active Ingredient(s): AMRINONE LACTATE
OTC/RX Status: RX

Original Abbreviated Application # 075629
Approval Date: 09-MAY-00
Trade Name: METHYLPHENIDATE HCL
Dosage Form: TABLET
Applicant: MALLINCKRODT INC
Active Ingredient(s): METHYLPHENIDATE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075513
Approval Date: 09-MAY-00
Trade Name: AMRINONE
Dosage Form: INJECTABLE
Applicant: BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
Active Ingredient(s): AMRINONE LACTATE
OTC/RX Status: RX

Original Abbreviated Application # 075520
Approval Date: 08-MAY-00
Trade Name: NORTRIPTYLINE HCL
Dosage Form: CAPSULE
Applicant: TARO PHARMACEUTICALS INC
Active Ingredient(s): NORTRIPTYLINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075167
Approval Date: 04-MAY-00
Trade Name: RANITIDINE HCL
Dosage Form: TABLET
Applicant: TORPHARM INC
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: OTC

Original Abbreviated Application # 040378
Approval Date: 03-MAY-00
Trade Name: NIACOR
Dosage Form: TABLET
Applicant: UPSHER SMITH LABORATORIES INC
Active Ingredient(s): NIACIN
OTC/RX Status: RX

Original Abbreviated Application # 040357
Approval Date: 02-MAY-00
Trade Name: DIPHENOXYLATE HCL AND ATROPINE SULFATE
Dosage Form: TABLET
Applicant: PAR PHARMACEUTICAL INC
Active Ingredient(s): DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE
OTC/RX Status: RX

Original Abbreviated Application # 075429
Approval Date: 01-MAY-00
Trade Name: SOTALOL HCL
Dosage Form: TABLET
Applicant: TEVA PHARMACEUTICALS USA INC
Active Ingredient(s): SOTALOL HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075366
Approval Date: 01-MAY-00
Trade Name: SOTALOL HCL
Dosage Form: TABLET
Applicant: EON LABORATORIES MANUFACTURING INC
Active Ingredient(s): SOTALOL HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075237
Approval Date: 01-MAY-00
Trade Name: SOTALOL HCL
Dosage Form: TABLET
Applicant: PAR PHARMACEUTICAL INC
Active Ingredient(s): SOTALOL HYDROCHLORIDE
OTC/RX Status: RX

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

Original Abbreviated Application #: 075396
Tentative Approval Date: 05-MAY-00
Trade Name: MIDAZOLAM HYDROCHLORIDE
Dosage Form: INJECTABLE
Applicant: FAULDING PHARMACEUTICAL CO
Active Ingredient(s): MIDAZOLAM HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application #: 075048
Tentative Approval Date: 02-MAY-00
Trade Name: ENALAPRIL MALEATE
Dosage Form: TABLET
Applicant: GENEVA PHARMACEUTICALS INC
Active Ingredient(s): ENALAPRIL MALEATE
OTC/RX Status: RX

Labeling Supplements to Original New Drug Applications

Application #: 018248 Labeling Supplement#: 027
To Original New Drug Application
Approval Date: 31-MAY-00
Trade Name: OXYTOCIN
Dosage Form: INJECTABLE
Applicant: AMERICAN PHARMACEUTICALS PARTNERS INC
Active Ingredient(s): OXYTOCIN SYNTHETIC
OTC/RX Status: RX

Application #: 050706 Labeling Supplement#: 005
To Original New Drug Application
Approval Date: 23-MAY-00
Trade Name: MERREM I.V.
Dosage Form: INJECTABLE
Applicant: ASTRAZENECA UK LTD
Active Ingredient(s): MEROPENEM
OTC/RX Status: RX

Application #: 020073 Labeling Supplement#: 010
To Original New Drug Application
Approval Date: 22-MAY-00
Trade Name: ROMAZICON
Dosage Form: INJECTABLE
Applicant: HLR TECHNOLOGY
Active Ingredient(s): FLUMAZENIL
OTC/RX Status: RX

Application #: 020760 Labeling Supplement#: 006
To Original New Drug Application
Approval Date: 17-MAY-00
Trade Name: TROVAN PRESERVATIVE FREE
Dosage Form: INJECTABLE
Applicant: PFIZER CHEMICALS DIV PFIZER INC
Active Ingredient(s): ALATROFLOXACIN MESYLATE
OTC/RX Status: RX

Application #: 020760 Labeling Supplement#: 005
To Original New Drug Application
Approval Date: 17-MAY-00
Trade Name: TROVAN PRESERVATIVE FREE
Dosage Form: INJECTABLE
Applicant: PFIZER CHEMICALS DIV PFIZER INC
Active Ingredient(s): ALATROFLOXACIN MESYLATE
OTC/RX Status: RX

Application #: 020760 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 17-MAY-00
Trade Name: TROVAN PRESERVATIVE FREE
Dosage Form: INJECTABLE
Applicant: PFIZER CHEMICALS DIV PFIZER INC
Active Ingredient(s): ALATROFLOXACIN MESYLATE
OTC/RX Status: RX

Application #: 020760 Labeling Supplement#: 003
To Original New Drug Application
Approval Date: 17-MAY-00
Trade Name: TROVAN PRESERVATIVE FREE
Dosage Form: INJECTABLE
Applicant: PFIZER CHEMICALS DIV PFIZER INC
Active Ingredient(s): ALATROFLOXACIN MESYLATE
OTC/RX Status: RX

Application #: 020759 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 17-MAY-00
Trade Name: TROVAN
Dosage Form: TABLET
Applicant: PFIZER CENTRAL RESEARCH
Active Ingredient(s): TROVAFLOXACIN MESYLATE
OTC/RX Status: RX

Application #: 020759 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 17-MAY-00
Trade Name: TROVAN
Dosage Form: TABLET
Applicant: PFIZER CENTRAL RESEARCH
Active Ingredient(s): TROVAFLOXACIN MESYLATE
OTC/RX Status: RX

Application #: 020759 Labeling Supplement#: 006
To Original New Drug Application
Approval Date: 17-MAY-00
Trade Name: TROVAN
Dosage Form: TABLET
Applicant: PFIZER CENTRAL RESEARCH
Active Ingredient(s): TROVAFLOXACIN MESYLATE
OTC/RX Status: RX

Application #: 020759 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 17-MAY-00
Trade Name: TROVAN
Dosage Form: TABLET
Applicant: PFIZER CENTRAL RESEARCH
Active Ingredient(s): TROVAFLOXACIN MESYLATE
OTC/RX Status: RX

Application #: 020388 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 12-MAY-00
Trade Name: NAVELBINE
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): VINORELBINE TARTRATE
OTC/RX Status: RX

Application #: 020298 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 12-MAY-00
Trade Name: ALOPRIM
Dosage Form: INJECTABLE
Applicant: CATALYTICA PHARMACEUTICALS INC
Active Ingredient(s): ALLOPURINOL SODIUM
OTC/RX Status: RX

Application #: 020758 Labeling Supplement#: 016
To Original New Drug Application
Approval Date: 09-MAY-00
Trade Name: AVALIDE
Dosage Form: TABLET
Applicant:BRISTOL-MYERS SQUIBB
Active Ingredient(s): IRBESARTAN; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX

Application #: 020757 Labeling Supplement#: 015
To Original New Drug Application
Approval Date: 09-MAY-00
Trade Name: AVAPRO
Dosage Form: TABLET
Applicant:BRISTOL-MYERS SQUIBB
Active Ingredient(s): IRBESARTAN
OTC/RX Status: RX

Application #: 020945 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 08-MAY-00
Trade Name: NORVIR
Dosage Form: CAPSULE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): RITONAVIR
OTC/RX Status: RX

Application #: 020659 Labeling Supplement#: 023
To Original New Drug Application
Approval Date: 08-MAY-00
Trade Name: NORVIR
Dosage Form: SOLUTION
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): RITONAVIR
OTC/RX Status: RX

Application #: 021085 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 04-MAY-00
Trade Name: AVELOX
Dosage Form: TABLET
Applicant: BAYER CORP PHARMACEUTICAL DIV
Active Ingredient(s): MOXIFLOXACIN HYDROCHLORIDE
OTC/RX Status: RX

Application #: 019856 Labeling Supplement#: 015
To Original New Drug Application
Approval Date: 02-MAY-00
Trade Name: SINEMET CR
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: DUPONT PHARMACEUTICALS CO
Active Ingredient(s): CARBIDOPA; LEVODOPA
OTC/RX Status: RX

Application #: 018701 Labeling Supplement#: 043
To Original New Drug Application
Approval Date: 02-MAY-00
Trade Name: HALDOL
Dosage Form: INJECTABLE
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): HALOPERIDOL DECANOATE
OTC/RX Status: RX

Application #: 018276 Labeling Supplement#: 035
To Original New Drug Application
Approval Date: 02-MAY-00
Trade Name: XANAX
Dosage Form: TABLET
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): ALPRAZOLAM
OTC/RX Status: RX

Application #: 015923 Labeling Supplement#: 066
To Original New Drug Application
Approval Date: 02-MAY-00
Trade Name: HALDOL
Dosage Form: INJECTABLE
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): HALOPERIDOL
OTC/RX Status: RX

Application #: 015922 Labeling Supplement#: 065
To Original New Drug Application
Approval Date: 02-MAY-00
Trade Name: HALDOL
Dosage Form: CONCENTRATE
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): HALOPERIDOL
OTC/RX Status: RX

Application #: 015921 Labeling Supplement#: 075
To Original New Drug Application
Approval Date: 02-MAY-00
Trade Name: HALDOL
Dosage Form: TABLET
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP
Active Ingredient(s): HALOPERIDOL
OTC/RX Status: RX

Application #: 000793 Labeling Supplement#: 020
To Original New Drug Application
Approval Date: 02-MAY-00
Trade Name: BUTISOL SODIUM
Dosage Form: TABLET
Applicant: WALLACE LABORATORIES DIV CARTER WALLACE INC
Active Ingredient(s): BUTABARBITAL SODIUM
OTC/RX Status: RX

Application #: 020768 Labeling Supplement#: 003
To Original New Drug Application
Approval Date: 01-MAY-00
Trade Name: ZOMIG
Dosage Form: TABLET
Applicant:ASTRAZENECA PHARMACEUTICALS LP
Active Ingredient(s): ZOLMITRIPTAN
OTC/RX Status: RX

Application #: 018662 Labeling Supplement#: 040
To Original New Drug Application
Approval Date: 01-MAY-00
Trade Name: ACCUTANE
Dosage Form: CAPSULE
Applicant: HLR TECHNOLOGY
Active Ingredient(s): ISOTRETINOIN
OTC/RX Status: RX

Application #: 018662 Labeling Supplement#: 039
To Original New Drug Application
Approval Date: 01-MAY-00
Trade Name: ACCUTANE
Dosage Form: CAPSULE
Applicant: HLR TECHNOLOGY
Active Ingredient(s): ISOTRETINOIN
OTC/RX Status: RX

Application #: 018662 Labeling Supplement#: 038
To Original New Drug Application
Approval Date: 01-MAY-00
Trade Name: ACCUTANE
Dosage Form: CAPSULE
Applicant: HLR TECHNOLOGY
Active Ingredient(s): ISOTRETINOIN
OTC/RX Status: RX

Application #: 016792 Labeling Supplement#: 020
To Original New Drug Application
Approval Date: 01-MAY-00
Trade Name: SURMONTIL
Dosage Form: CAPSULE
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): TRIMIPRAMINE MALEATE
OTC/RX Status: RX