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Drug Approvals for May 2002
Definitions and Notes
Original New Drug Applications
Original Abbreviated Antibiotic Application # 065082
Approval Date: 31-MAY-02
Trade Name: CEFPODOXIME PROXETIL
Dosage Form: GRANULE, FOR RECONSTITUTION
Applicant: RANBAXY LABORATORIES LTD
Active Ingredient(s): CEFPODOXIME PROXETIL
OTC/RX Status: RX
Original Application #: 021292
Approval Date: 31-MAY-02
Trade Name: NOVOTHYROX
Chemical Type: 5
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: GENPHARM, INC
Active Ingredient(s): LEVOTHYROXINE SODIUM
OTC/RX Status: RX
Indication(s): For hypothyroidism and suppression of thyroid-stimulating hormone
Original Application #: 021191
Approval Date: 31-MAY-02
Trade Name: IMAGENT
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: ALLIANCE PHARMACEUTICAL CORP
Active Ingredient(s): DIMYRISTOYL LECITHIN; PERFLEXANE
OTC/RX Status: RX
Indication(s): For use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border
Original Application #: 021374
Approval Date: 30-MAY-02
Trade Name: ADVIL COLD AND SINUS
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: CAPSULE
Applicant: WYETH CONSUMER HEALTHCARE
Active Ingredient(s): IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): For use in patients 12 years of age and older for temporary relief of symptoms associated with the common cold, sinusitis, or flue, including nasal congestion, headache, fever, body aches and pains
Original Application #: 050784
Approval Date: 24-MAY-02
Trade Name: ZITHROMAX
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: PFIZER INC
Active Ingredient(s): AZITHROMYCIN DIHYDRATE
OTC/RX Status: RX
Indication(s): For the treatment of acute exacerbation of chronic obstructive pulmonary disease
Original Application #: 021424
Approval Date: 24-MAY-02
Trade Name: NEURONTIN
Chemical Type: 6
Therapeutic Potential: S
Dosage Form: SOLUTION
Applicant: PARKE DAVIS PHARMACEUTICALS LTD
Active Ingredient(s): GABAPENTIN
OTC/RX Status: RX
Indication(s): For the management of postherpetic neuralgia
Original Application #: 021423
Approval Date: 24-MAY-02
Trade Name: NEURONTIN
Chemical Type: 6
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: PARKE DAVIS PHARMACEUTICALS LTD
Active Ingredient(s): GABAPENTIN
OTC/RX Status: RX
Indication(s): For the management of postherpetic neuralgia
Original Application #: 021397
Approval Date: 24-MAY-02
Trade Name: NEURONTIN
Chemical Type: 6
Therapeutic Potential: S
Dosage Form: CAPSULE
Applicant: PARKE DAVIS PHARMACEUTICALS LTD
Active Ingredient(s): GABAPENTIN
OTC/RX Status: RX
Indication(s): For the management of postherpetic neuralgia
Original Application #: 021267
Approval Date: 24-MAY-02
Trade Name: VFEND
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: PFIZER GLOBAL RESEARCH DEVELOPMENT
Active Ingredient(s): VORICONAZOLE
OTC/RX Status: RX
Indication(s): For the treatment of invasive aspergillosis and serious fungal infections caused by Scedosporium apiospermum and Fusarium spp., including Fusarium solani, in patients intolerant of, or refractory to, other therapy
Original Application #: 021266
Approval Date: 24-MAY-02
Trade Name: VFEND
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: PFIZER GLOBAL RESEARCH DEVELOPMENT
Active Ingredient(s): VORICONAZOLE
OTC/RX Status: RX
Indication(s): For the treatment of invasive aspergillosis and serious fungal infections caused by Scedosporium apiospermum and Fusarium spp., including Fusarium solani, in patients intolerant of, or refractory to, other therapy
Original Application #: 021272
Approval Date: 21-MAY-02
Trade Name: REMODULIN
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: INJECTABLE
Applicant: UNITED THERAPEUTICS CORP
Active Ingredient(s): TREPROSTINIL SODIUM
OTC/RX Status: RX
Indication(s): For the treatment of pulmonary arterial hypertension (PAH)
Original Application #: 021289
Approval Date: 06-MAY-02
Trade Name: BRAVELLE
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: FERRING PHARMACEUTICALS INC
Active Ingredient(s): UROFOLLITROPIN
OTC/RX Status: RX
Indication(s): For ovulation induction
Efficacy Supplemental New Drug Applications
Application #: 050697 Efficacy Supplement #: 002
Type: SE7 to Original New Drug Application
Approval Date: 24-MAY-02
Trade Name: BIAXIN
Dosage Form: TABLET
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): CLARITHROMYCIN
OTC/RX Status: RX
Efficacy Claim: For the treatment of disseminated mycobacterial infections due to Mycobaceterium avium and Mycobacterium intracellulare
Application #: 020121 Efficacy Supplement #: 023
Type: SE2 to Original New Drug Application
Approval Date: 23-MAY-02
Trade Name: FLONASE
Dosage Form: SPRAY, METERED
Applicant: GLAXOSMITHKLINE
Active Ingredient(s): FLUTICASONE PROPIONATE
OTC/RX Status: RX
Efficacy Claim: For the management of nasal symptoms in patients for whom the drug is indicated
Application #: 020911 Efficacy Supplement #: 005
Type: SE5 to Original New Drug Application
Approval Date: 10-MAY-02
Trade Name: QVAR 80
Dosage Form: AEROSOL, METERED
Applicant: 3M PHARMACEUTICALS INC
Active Ingredient(s): BECLOMETHASONE DIPROPIONATE
OTC/RX Status: RX
Efficacy Claim: For maintenance treatment of asthma in children 5 through 11 years of age
Application #: 020475 Efficacy Supplement #: 008
Type: SE2 to Original New Drug Application
Approval Date: 10-MAY-02
Trade Name: RETIN-A MICRO
Dosage Form: GEL
Applicant: JOHNSON AND JOHNSON CONSUMER COMPANIES INC
Active Ingredient(s): TRETINOIN
OTC/RX Status: RX
Efficacy Claim: For topical application for the treatment of acne vulgaris
Application #: 020911 Efficacy Supplement #: 005
Type: SE5 to Original New Drug Application
Approval Date: 09-MAY-02
Trade Name: QVAR 80
Dosage Form: AEROSOL, METERED
Applicant: 3M PHARMACEUTICALS INC
Active Ingredient(s): BECLOMETHASONE DIPROPIONATE
OTC/RX Status: RX
Efficacy Claim: For maintenance treatment of asthma in children 5 through 11 years of age
Application #: 020538 Efficacy Supplement #: 015
Type: SE1 to Original New Drug Application
Approval Date: 03-MAY-02
Trade Name: VIVELLE-DOT
Dosage Form: FILM, CONTROLLED RELEASE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): ESTRADIOL
OTC/RX Status: RX
Efficacy Claim: For the prevention of postmenopausal indication in at-risk patients for the .25/mg day strength
Application #: 020538 Efficacy Supplement #: 014
Type: SE8 to Original New Drug Application
Approval Date: 03-MAY-02
Trade Name: VIVELLE-DOT
Dosage Form: FILM, CONTROLLED RELEASE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): ESTRADIOL
OTC/RX Status: RX
Efficacy Claim: Treatment of moderate-to-severe vasomotor symptoms associated with the menopause; treatment of vulvar and vaginal atrophy; treatment of hypoestrogenism due to hypogonadism, castration, or pirmary ovarian failure; prevention of postmenopausal osteoporosis
Approvable Original New Drug Applications
Original Abbreviated Application # 076229
Approval Date: 31-MAY-02
Trade Name: AMCINONIDE
Dosage Form: EMULSION, CREAM
Applicant: TARO PHARMACEUTICAL INDUSTRIES LTD
Active Ingredient(s): AMCINONIDE
OTC/RX Status: RX
Original Abbreviated Application # 075586
Approval Date: 30-MAY-02
Trade Name: METAPROTERENOL SULFATE
Dosage Form: SOLUTION
Applicant: MORTON GROVE PHARMACEUTICALS INC
Active Ingredient(s): METAPROTERENOL SULFATE
OTC/RX Status: RX
Original Abbreviated Antibiotic Application # 075660
Approval Date: 28-MAY-02
Trade Name: MILRINONE LACTATE INJECTION
Dosage Form: INJECTABLE
Applicant: BEDFORD LABORATORIES
Active Ingredient(s): MILRINONE LACTATE
OTC/RX Status: RX
Original Abbreviated Application # 040466
Approval Date: 28-MAY-02
Trade Name: DIPHENHYDRAMINE HCL
Dosage Form: INJECTABLE
Applicant: AMERICAN PHARMACEUTICAL PARTNERS INC
Active Ingredient(s): DIPHENHYDRAMINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 076078
Approval Date: 28-MAY-02
Trade Name: IFSOFAMIDE
Dosage Form: INJECTABLE
Applicant: AMERICAN PHARMACEUTICAL PARTNERS INC
Active Ingredient(s): IFOSFAMIDE
OTC/RX Status: RX
Original Abbreviated Application # 075852
Approval Date: 28-MAY-02
Trade Name: MILRINONE LACTATE
Dosage Form: INJECTABLE
Applicant: BAXTER HEALTHCARE CORP
Active Ingredient(s): MILRINONE LACTATE
OTC/RX Status: RX
Original Abbreviated Application # 075830
Approval Date: 28-MAY-02
Trade Name: MILRINONE LACTATE
Dosage Form: INJECTABLE
Applicant: FAULDING PHARMACEUTICAL CO
Active Ingredient(s): MILRINONE LACTATE
OTC/RX Status: RX
Original Abbreviated Application # 075936
Approval Date: 28-MAY-02
Trade Name: MILRINONE LACTATE
Dosage Form: INJECTABLE
Applicant: AMERICAN PHARMACEUTICAL PARTNERS INC
Active Ingredient(s): MILRINONE LACTATE
OTC/RX Status: RX
Original Abbreviated Application # 075884
Approval Date: 28-MAY-02
Trade Name: MILRINONE LACTATE
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): MILRINONE LACTATE
OTC/RX Status: RX
Original Abbreviated Application # 075530
Approval Date: 28-MAY-02
Trade Name: MILRINONE LACTATE
Dosage Form: INJECTABLE
Applicant: ESI LEDERLE INC
Active Ingredient(s): MILRINONE LACTATE
OTC/RX Status: RX
Original Abbreviated Application # 075510
Approval Date: 28-MAY-02
Trade Name: MILRINONE LACTATE IN DEXTROSE 5%
Dosage Form: INJECTABLE
Applicant: ESI LEDERLE GENERICS
Active Ingredient(s): MILRINONE LACTATE
OTC/RX Status: RX
Original Abbreviated Application # 075885
Approval Date: 28-MAY-02
Trade Name: MILRINONE LACTATE IN DEXTROSE 5%
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): MILRINONE LACTATE
OTC/RX Status: RX
Original Abbreviated Application # 075834
Approval Date: 28-MAY-02
Trade Name: MILRINONE LACTATE IN 5% DEXTROSE
Dosage Form: INJECTABLE
Applicant: BAXTER HEALTHCARE CORP
Active Ingredient(s): MILRINONE LACTATE
OTC/RX Status: RX
Original Abbreviated Antibiotic Application # 065010
Approval Date: 23-MAY-02
Trade Name: NEO-FRADIN ORAL SOLUTION
Dosage Form: SOLUTION
Applicant: PHARMATEK INC
Active Ingredient(s): NEOMYCIN SULFATE
OTC/RX Status: RX
Original Abbreviated Application # 075866
Approval Date: 23-MAY-02
Trade Name: PORTIA
Dosage Form: TABLET
Applicant: BARR LABORATORIES INC
Active Ingredient(s): ETHINYL ESTRADIOL; LEVONORGESTREL
OTC/RX Status: RX
Original Abbreviated Application # 076207
Approval Date: 17-MAY-02
Trade Name: PAMIDRONATE DISODIUM
Dosage Form: INJECTABLE
Applicant: AMERICAN PHARMACEUTICAL PARNERS, INC
Active Ingredient(s): PAMIDRONATE DISODIUM
OTC/RX Status: RX
Original Abbreviated Application # 076110
Approval Date: 14-MAY-02
Trade Name: TORSEMIDE
Dosage Form: TABLET
Applicant: TEVA PHARMACEUTICALS USA INC
Active Ingredient(s): TORSEMIDE
OTC/RX Status: RX
Original Abbreviated Application # 075846
Approval Date: 13-MAY-02
Trade Name: OXAPROZIN
Dosage Form: TABLET
Applicant: IVAX PHARMACEUTICALS INC
Active Ingredient(s): OXAPROZIN
OTC/RX Status: RX
Original Abbreviated Application # 075388
Approval Date: 09-MAY-02
Trade Name: BUSPIRONE HCL
Dosage Form: TABLET
Applicant: PHARMEX PRODUCTS INC
Active Ingredient(s): BUSPIRONE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Antibiotic Application # 065040
Approval Date: 09-MAY-02
Trade Name: CYCLOSPORINE
Dosage Form: CAPSULE
Applicant: TORPHARM INC
Active Ingredient(s): CYCLOSPORINE
OTC/RX Status: RX
Original Abbreviated Application # 075773
Approval Date: 06-MAY-02
Trade Name: PAMIDRONATE DISODIUM
Dosage Form: INJECTABLE
Applicant: AMERICAN PHARMACEUTICAL PARTNERS INC
Active Ingredient(s): PAMIDRONATE DISODIUM
OTC/RX Status: RX
Original Abbreviated Application # 075594
Approval Date: 06-MAY-02
Trade Name: PAMIDRONATE DISODIUM
Dosage Form: INJECTABLE
Applicant: AESGEN INC
Active Ingredient(s): PAMIDRONATE DISODIUM
OTC/RX Status: RX
Original Abbreviated Application # 075774
Approval Date: 1-MAY-02
Trade Name: AMMONIUM LACTATE
Dosage Form: CREAM
Applicant: CLAY-PARK LABS, INC
Active Ingredient(s): AMMONIUM LACTATE
OTC/RX Status: RX
Original Abbreviated Application # 065036
Approval Date: 01-MAY-02
Trade Name: IDARUBICIN HYDROCHLORIDE
Dosage Form: INJECTABLE
Applicant: GENSIA SICOR PHARMACEUTICALS INC
Active Ingredient(s): IDARUBICIN HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Antibiotic Application # 065037
Approval Date: 01-MAY-02
Trade Name: IDARUBICIN HCL
Dosage Form: INJECTABLE
Applicant: GENSIA SICOR PHARMACEUTICALS INC
Active Ingredient(s): IDARUBICIN HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated and 505(b)(2) New Drug Applications with Tentative Approval
Original Abbreviated Application #: 076235
Tentative Approval Date: 22-MAY-02
Trade Name: CARBOPLATIN
Dosage Form: INJECTABLE
Applicant: AMERICAN PHARMACEUTICAL PARTNERS INC
Active Ingredient(s): CARBOPLATIN
OTC/RX Status: RX
Original Abbreviated Application #: 076056
Tentative Approval Date: 15-MAY-02
Trade Name: PRAVASTATIN SODIUM
Dosage Form: TABLET
Applicant: PHARMACEUTICAL ASSOC INC
Active Ingredient(s): PRAVASTATIN SODIUM
OTC/RX Status: RX
Original Abbreviated Application #: 076123
Tentative Approval Date: 13-MAY-02
Trade Name: PREDNISOLONE SODIUM PHOSPHATE
Dosage Form: SOLUTION
Applicant: PHARMACEUTICAL ASSOC INC
Active Ingredient(s): PREDNISOLONE SODIUM PHOSPHATE
OTC/RX Status: RX
Original Abbreviated Application #: 076231
Tentative Approval Date: 13-MAY-02
Trade Name: OFLOXACIN
Dosage Form: SOLUTION, DROPS
Applicant: ALCON UNIVERSAL LTD
Active Ingredient(s): OFLOXACIN
OTC/RX Status: RX
Original Abbreviated Application #: 076104
Tentative Approval Date: 08-MAY-02
Trade Name: ITRACONAZOLE
Dosage Form: CAPSULE
Applicant: EON LABORATORIES MANUFACTURING INC
Active Ingredient(s): ITRACONAZOLE
OTC/RX Status: RX
Original Abbreviated Application # 076131
Approval Date: 08-MAY-02
Trade Name: PACLITAXEL
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): PACLITAXEL
OTC/RX Status: RX
Original Abbreviated Application #: 076018
Tentative Approval Date: 07-MAY-02
Trade Name: AMIODARONE HCL
Dosage Form: INJECTABLE
Applicant: BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
Active Ingredient(s): AMIODARONE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application #: 076223
Tentative Approval Date: 06-MAY-02
Trade Name: METFORMIN HCL
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: GENEVA PHARMACEUTICALS TECHNOLOGY CORP
Active Ingredient(s): METFORMIN HYDROCHLORIDE
OTC/RX Status: RX
Labeling Supplements to Original New Drug Applications
Application #: 050649 Labeling Supplement #: 011
To Original New Drug Application
Approval Date: 31-MAY-02
Trade Name: MINOCIN
Dosage Form: CAPSULE
Applicant: WYETH PHARMACEUTICALS
Active Ingredient(s): MINOCYCLINE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 050445 Labeling Supplement #: 019
To Original New Drug Application
Approval Date: 31-MAY-02
Trade Name: MINOCIN
Dosage Form: SUSPENSION
Applicant: WYETH PHARMACEUTICALS
Active Ingredient(s): MINOCYCLINE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 050444 Labeling Supplement #: 036
To Original New Drug Application
Approval Date: 31-MAY-02
Trade Name: MINOCIN
Dosage Form: INJECTABLE
Applicant: WYETH PHARMACEUTICALS
Active Ingredient(s): MINOCYCLINE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 020859 Labeling Supplement #: 003
To Original New Drug Application
Approval Date: 31-MAY-02
Trade Name: SONATA
Dosage Form: CAPSULE
Applicant: WYETH AYERST LABORATORIES
Active Ingredient(s): ZALEPLON
OTC/RX Status: RX
Application #: 020859 Labeling Supplement #: 002
To Original New Drug Application
Approval Date: 31-MAY-02
Trade Name: SONATA
Dosage Form: CAPSULE
Applicant: WYETH AYERST LABORATORIES
Active Ingredient(s): ZALEPLON
OTC/RX Status: RX
Application #: 018163 Labeling Supplement #: 053
To Original New Drug Application
Approval Date: 31-MAY-02
Trade Name: RESTORIL
Dosage Form: CAPSULE
Applicant: MALLINCKRODT INC
Active Ingredient(s): TEMAZEPAM
OTC/RX Status: RX
Application #: 013217 Labeling Supplement #: 044
To Original New Drug Application
Approval Date: 31-MAY-02
Trade Name: SKELAXIN
Dosage Form: TABLET
Applicant: ELAN PHARMACEUTICALS INC
Active Ingredient(s): METAXALONE
OTC/RX Status: RX
Application #: 018066 Labeling Supplement #: 013
To Original New Drug Application
Approval Date: 30-MAY-02
Trade Name: UNISOM
Dosage Form: TABLET
Applicant: PFIZER LABORATORIES DIV PFIZER INC
Active Ingredient(s): DOXYLAMINE SUCCINATE
OTC/RX Status: OTC
Application #: 019787 Labeling Supplement #: 032
To Original New Drug Application
Approval Date: 28-MAY-02
Trade Name: NORVASC
Dosage Form: TABLET
Applicant: PFIZER AGRICULTURAL DIV
Active Ingredient(s): AMLODIPINE BESYLATE
OTC/RX Status: RX
Application #: 050711 Labeling Supplement #: 009
To Original New Drug Application
Approval Date: 24-MAY-02
Trade Name: ZITHROMAX
Dosage Form: TABLET
Applicant: PFIZER INC
Active Ingredient(s): AZITHROMYCIN DIHYDRATE
OTC/RX Status: RX
Application #: 050710 Labeling Supplement #: 011
To Original New Drug Application
Approval Date: 24-MAY-02
Trade Name: ZITHROMAX
Dosage Form: SUSPENSION
Applicant: PFIZER CHEMICALS DIV PFIZER INC
Active Ingredient(s): AZITHROMYCIN DIHYDRATE
OTC/RX Status: RX
Application #: 050606 Labeling Supplement #: 015
To Original New Drug Application
Approval Date: 24-MAY-02
Trade Name: VANCOCIN HCL
Dosage Form: CAPSULE
Applicant: ELI LILLY AND CO
Active Ingredient(s): VANCOMYCIN HYDROCHLORIDE
OTC/RX Status: RX
Application #: 050678 Labeling Supplement #: 010
To Original New Drug Application
Approval Date: 23-MAY-02
Trade Name: DYNABAC
Dosage Form: TABLET
Applicant: LILLY RESEARCH LABORATORIES
Active Ingredient(s): DIRITHROMYCIN
OTC/RX Status: RX
Application #: 050609 Labeling Supplement #: 015
To Original New Drug Application
Approval Date: 23-MAY-02
Trade Name: ERYTHROCIN
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES HOSP PRODUCTS DIV
Active Ingredient(s): ERYTHROMYCIN LACTOBIONATE
OTC/RX Status: RX
Application #: 050182 Labeling Supplement #: 122
To Original New Drug Application
Approval Date: 23-MAY-02
Trade Name: ERYTHROCIN LACTOBIONATE
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES HOSP PRODUCTS DIV
Active Ingredient(s): ERYTHROMYCIN LACTOBIONATE
OTC/RX Status: RX
Application #: 021277 Labeling Supplement #: 001
To Original New Drug Application
Approval Date: 22-MAY-02
Trade Name: AVELOX
Dosage Form: INJECTABLE
Applicant: BAYER CORP PHARMACEUTICAL DIV
Active Ingredient(s): MOXIFLOXACIN HYDROCHLORIDE
OTC/RX Status: RX
Application #: 021035 Labeling Supplement #: 019
To Original New Drug Application
Approval Date: 22-MAY-02
Trade Name: KEPPRA
Dosage Form: TABLET
Applicant: UCB PHARMA INC
Active Ingredient(s): LEVETIRACETAM
OTC/RX Status: RX
Application #: 021035 Labeling Supplement #: 013
To Original New Drug Application
Approval Date: 22-MAY-02
Trade Name: KEPPRA
Dosage Form: TABLET
Applicant: UCB PHARMA INC
Active Ingredient(s): LEVETIRACETAM
OTC/RX Status: RX
Application #: 019834 Labeling Supplement #: 017
To Original New Drug Application
Approval Date: 22-MAY-02
Trade Name: PLENDIL
Dosage Form: TABLET
Applicant: ASTRAZENECA PHARMACEUTICALS LP
Active Ingredient(s): FELODIPINE
OTC/RX Status: RX
Application #: 020105 Labeling Supplement #: 002
To Original New Drug Application
Approval Date: 20-MAY-02
Trade Name: TRIOSTAT
Dosage Form: INJECTABLE
Applicant: JONES PHARMA INC SUB KING PHARMACEUTICALS INC
Active Ingredient(s): LIOTHYRONINE SODIUM
OTC/RX Status: RX
Application #: 020571 Labeling Supplement #: 016
To Original New Drug Application
Approval Date: 16-MAY-02
Trade Name: CAMPTOSAR
Dosage Form: INJECTABLE
Applicant: PHARMACIA & UPJOHN COMPANY
Active Ingredient(s): IRINOTECAN HYDROCHLORIDE
OTC/RX Status: RX
Application #: 017970 Labeling Supplement #: 049
To Original New Drug Application
Approval Date: 16-MAY-02
Trade Name: NOLVADEX
Dosage Form: TABLET
Applicant: ASTRAZENECA PHARMACEUTICALS LP
Active Ingredient(s): TAMOXIFEN CITRATE
OTC/RX Status: RX
Application #: 020408 Labeling Supplement #: 025
To Original New Drug Application
Approval Date: 15-MAY-02
Trade Name: TRUSOPT
Dosage Form: SOLUTION, DROPS
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): DORZOLAMIDE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 020408 Labeling Supplement #: 023
To Original New Drug Application
Approval Date: 15-MAY-02
Trade Name: TRUSOPT
Dosage Form: SOLUTION, DROPS
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): DORZOLAMIDE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 020626 Labeling Supplement #: 006
To Original New Drug Application
Approval Date: 10-MAY-02
Trade Name: IMITREX
Dosage Form: INJECTABLE
Applicant: GLAXOSMITHKLINE
Active Ingredient(s): SUMATRIPTAN
OTC/RX Status: RX
Application #: 014713 Labeling Supplement #: 032
To Original New Drug Application
Approval Date: 10-MAY-02
Trade Name: ETRAFON
Dosage Form: TABLET
Applicant: SCHERING CORP SUB SCHERING PLOUGH CORP
Active Ingredient(s): AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
OTC/RX Status: RX
Application #: 011213 Labeling Supplement #: 024
To Original New Drug Application
Approval Date: 10-MAY-02
Trade Name: TRILAFON
Dosage Form: INJECTABLE
Applicant: SCHERING CORP SUB SCHERING PLOUGH CORP
Active Ingredient(s): PERPHENAZINE
OTC/RX Status: RX
Application #: 010775 Labeling Supplement #: 031
To Original New Drug Application
Approval Date: 10-MAY-02
Trade Name: TRILAFON
Dosage Form: TABLET
Applicant: SCHERING CORP SUB SCHERING PLOUGH CORP
Active Ingredient(s): PERPHENAZINE
OTC/RX Status: RX
Application #: 020409 Labeling Supplement #: 011
To Original New Drug Application
Approval Date: 09-MAY-02
Trade Name: NASAREL
Dosage Form: SPRAY, METERED
Applicant: IVAX RESEARCH INC
Active Ingredient(s): FLUNISOLIDE
OTC/RX Status: RX
Application #: 020409 Labeling Supplement #: 005
To Original New Drug Application
Approval Date: 09-MAY-02
Trade Name: NASAREL
Dosage Form: SPRAY, METERED
Applicant: IVAX RESEARCH INC
Active Ingredient(s): FLUNISOLIDE
OTC/RX Status: RX
Application #: 020121 Labeling Supplement #: 020
To Original New Drug Application
Approval Date: 09-MAY-02
Trade Name: FLONASE
Dosage Form: SPRAY, METERED
Applicant: GLAXOSMITHKLINE
Active Ingredient(s): FLUTICASONE PROPIONATE
OTC/RX Status: RX
Application #: 020121 Labeling Supplement #: 013
To Original New Drug Application
Approval Date: 09-MAY-02
Trade Name: FLONASE
Dosage Form: SPRAY, METERED
Applicant: GLAXOSMITHKLINE
Active Ingredient(s): FLUTICASONE PROPIONATE
OTC/RX Status: RX
Application #: 020121 Labeling Supplement #: 011
To Original New Drug Application
Approval Date: 09-MAY-02
Trade Name: FLONASE
Dosage Form: SPRAY, METERED
Applicant: GLAXOSMITHKLINE
Active Ingredient(s): FLUTICASONE PROPIONATE
OTC/RX Status: RX
Application #: 018148 Labeling Supplement #: 035
To Original New Drug Application
Approval Date: 09-MAY-02
Trade Name: NASALIDE
Dosage Form: SPRAY, METERED
Applicant: IVAX RESEARCH INC
Active Ingredient(s): FLUNISOLIDE
OTC/RX Status: RX
Application #: 018148 Labeling Supplement #: 030
To Original New Drug Application
Approval Date: 09-MAY-02
Trade Name: NASALIDE
Dosage Form: SPRAY, METERED
Applicant: IVAX RESEARCH INC
Active Ingredient(s): FLUNISOLIDE
OTC/RX Status: RX
Application #: 018152 Labeling Supplement #: 016
To Original New Drug Application
Approval Date: 08-MAY-02
Trade Name: LITHIUM
Dosage Form: TABLET
Applicant: GLAXOSMITHKLINE
Active Ingredient(s): LITHIUM CARBONATE
OTC/RX Status: RX
Application #: 018152 Labeling Supplement #: 013
To Original New Drug Application
Approval Date: 08-MAY-02
Trade Name: LITHIUM
Dosage Form: TABLET
Applicant: GLAXOSMITHKLINE
Active Ingredient(s): LITHIUM CARBONATE
OTC/RX Status: RX
Application #: 018152 Labeling Supplement #: 012
To Original New Drug Application
Approval Date: 08-MAY-02
Trade Name: LITHIUM
Dosage Form: TABLET
Applicant: GLAXOSMITHKLINE
Active Ingredient(s): LITHIUM CARBONATE
OTC/RX Status: RX
Application #: 018152 Labeling Supplement #: 010
To Original New Drug Application
Approval Date: 08-MAY-02
Trade Name: LITHIUM
Dosage Form: TABLET
Applicant: GLAXOSMITHKLINE
Active Ingredient(s): LITHIUM CARBONATE
OTC/RX Status: RX
Application #: 018152 Labeling Supplement #: 008
To Original New Drug Application
Approval Date: 08-MAY-02
Trade Name: LITHIUM
Dosage Form: TABLET
Applicant: GLAXOSMITHKLINE
Active Ingredient(s): LITHIUM CARBONATE
OTC/RX Status: RX
Application #: 018152 Labeling Supplement #: 003
To Original New Drug Application
Approval Date: 08-MAY-02
Trade Name:LITHIUM
Dosage Form: TABLET
Applicant: GLAXOSMITHKLINE
Active Ingredient(s): LITHIUM CARBONATE
OTC/RX Status: RX
Application #: 016860 Labeling Supplement #: 072
To Original New Drug Application
Approval Date: 08-MAY-02
Trade Name: LITHIUM
Dosage Form: CAPSULE
Applicant: GLAXOSMITHKLINE
Active Ingredient(s): LITHIUM CARBONATE
OTC/RX Status: RX
Application #: 016860 Labeling Supplement #: 069
To Original New Drug Application
Approval Date: 08-MAY-02
Trade Name: LITHIUM
Dosage Form: CAPSULE
Applicant: GLAXOSMITHKLINE
Active Ingredient(s): LITHIUM CARBONATE
OTC/RX Status: RX
Application #: 016860 Labeling Supplement #: 068
To Original New Drug Application
Approval Date: 08-MAY-02
Trade Name: LITHIUM
Dosage Form: CAPSULE
Applicant: GLAXOSMITHKLINE
Active Ingredient(s): LITHIUM CARBONATE
OTC/RX Status: RX
Application #: 016860 Labeling Supplement #: 067
To Original New Drug Application
Approval Date: 08-MAY-02
Trade Name: LITHIUM
Dosage Form: CAPSULE
Applicant: GLAXOSMITHKLINE
Active Ingredient(s): LITHIUM CARBONATE
OTC/RX Status: RX
Application #: 016860 Labeling Supplement #: 065
To Original New Drug Application
Approval Date: 08-MAY-02
Trade Name: LITHIUM
Dosage Form: CAPSULE
Applicant: GLAXOSMITHKLINE
Active Ingredient(s): LITHIUM CARBONATE
OTC/RX Status: RX
Application #: 016860 Labeling Supplement #: 059
To Original New Drug Application
Approval Date: 08-MAY-02
Trade Name: LITHIUM
Dosage Form: CAPSULE
Applicant: GLAXOSMITHKLINE
Active Ingredient(s): LITHIUM CARBONATE
OTC/RX Status: RX
Application #: 012301 Labeling Supplement #: 023
To Original New Drug Application
Approval Date: 07-MAY-02
Trade Name: LIBRIUM
Dosage Form: INJECTABLE
Applicant: ICN PHARMACEUTICALS INC
Active Ingredient(s): CHLORDIAZEPOXIDE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 019766 Labeling Supplement #: 051
To Original New Drug Application
Approval Date: 06-MAY-02
Trade Name: ZOCOR
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): SIMVASTATIN
OTC/RX Status: RX
Application #: 050528 Labeling Supplement #: 018
To Original New Drug Application
Approval Date: 03-MAY-02
Trade Name: DURICEF
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB CO
Active Ingredient(s): CEFADROXIL MONOHYDRATE
OTC/RX Status: RX
Application #: 050527 Labeling Supplement #: 020
To Original New Drug Application
Approval Date: 03-MAY-02
Trade Name: DURICEF
Dosage Form: SUSPENSION
Applicant: BRISTOL MYERS SQUIBB CO
Active Ingredient(s): CEFADROXIL MONOHYDRATE
OTC/RX Status: RX
Application #: 050512 Labeling Supplement #: 044
To Original New Drug Application
Approval Date: 03-MAY-02
Trade Name: DURICEF
Dosage Form: CAPSULE
Applicant: BRISTOL MYERS SQUIBB CO
Active Ingredient(s): CEFADROXIL MONOHYDRATE
OTC/RX Status: RX
Application #: 021281 Labeling Supplement #: 002
To Original New Drug Application
Approval Date: 03-MAY-02
Trade Name: PREVACID
Dosage Form: SUSPENSION
Applicant: TAP PHARMACEUTICAL PRODUCTS INC
Active Ingredient(s): LANSOPRAZOLE
OTC/RX Status: RX
Application #: 020538 Labeling Supplement #: 012
To Original New Drug Application
Approval Date: 03-MAY-02
Trade Name: VIVELLE-DOT
Dosage Form: FILM, CONTROLLED RELEASE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): ESTRADIOL
OTC/RX Status: RX
Application #: 020406 Labeling Supplement #: 045
To Original New Drug Application
Approval Date: 03-MAY-02
Trade Name: PREVACID
Dosage Form: CAPSULE
Applicant: TAP PHARMACEUTICAL PRODUCTS INC
Active Ingredient(s): LANSOPRAZOLE
OTC/RX Status: RX
Application #: 009218 Labeling Supplement #: 099
To Original New Drug Application
Approval Date: 03-MAY-02
Trade Name: COUMADIN
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB PHARMA CO
Active Ingredient(s): WARFARIN SODIUM
OTC/RX Status: RX
Application #: 009218 Labeling Supplement #: 098
To Original New Drug Application
Approval Date: 03-MAY-02
Trade Name: COUMADIN
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB PHARMA CO
Active Ingredient(s): WARFARIN SODIUM
OTC/RX Status: RX
Approvable Original New Drug Applications
An approvable letter indicates that FDA is prepared to approve the application upon the satisfaction of conditions specified in the approvable letter. Drug products which are the subject of approvable letters may not be legally marketed until the firm has satisfied the identified deficiencies, as well as any other requirements that may be imposed by FDA, and has been notified in writing that the application has been approved. Further information on approvable NDAs is not subject to Freedom of Information (FOI) release until applications are approved.
Original Abbreviated and 505(b)(2) New Drug Applications with Tentative Approval
A tentative approval indicates that FDA has given an abbreviated new drug application (ANDA) or 505(b)(2) application provisional approval under the terms of the Drug Price Competition and Patent Term Restoration Act. Such drug products that are the subjects of tentative approvals may not be legally marketed until the market exclusivity and/or patent term of the listed reference drug product has expired. Final approval is also contingent upon conditions and information available to FDA remaining acceptable. When the application receives final approval, the product may be legally marketed. The effective approval date will be listed in this publication and in the " Approved Drug Products with Therapeutic Equivalence Evaluations" list published by FDA. Additional information on these applications will become available to the public when the applications receive final approval. Notes
FDA classifies investigational new drug applications (INDs) and new drug applications (NDAs) to assign review priority on the basis of the drug's chemical type and potential benefit:
Chemical Type (CHE)
1. New molecular entity, or NME: An active ingredient that has never been marketed in this country.
2. New derivative: A chemical derived from an active ingredient already marketed (a "parent" drug).
3. New formulation: A new dosageform or new formulation of an active ingredient already on the market.
4. New combination: A drug that contains two or more compounds, the combination of which has not been marketed together in a product.
5. Already marketed drug product but a new manufacturer: A product that duplicates another firm's already marketed drug product: same active ingredient, formulation, or combination.
6. Already marketed drug product, but a new use: A new use for a drug product already marketed by a different firm.
7. Drug already legally marketed without an approved NDA
1 - First post-1962 applications for products marketed prior to 1938
2 - First applications for DESI-related products first marketed between 1938 and 1962 without NDAs
3 - First applications for DESI-related products first marketed after 1962 without NDAs - The indications can be the same or different from the legally marketed product
Effectiveness Supplement Code Definitions
SE1 A new indication or a significant modification of an existing indication, including removal of a major limitation to use, such as second line status.
SE2 A new dosage regimen, including an increase or decrease in daily dosage, or a change in frequency of administration.
SE3 A new route of administration.
SE4 A comparative efficacy claim naming another drug, including a comparative pharmacokinetic claim.
SE5 A change in sections other than the INDICATIONS AND USAGE section that would significantly alter the patient population to be treated, such as addition of pediatric use and/or dosing information or geriatric use and/or dosing information.
SE6 An Rx-to-OTC switch.
SE7 Supplement-Accelerated Approval
SE8 Efficacy Supplement with Clinical Data to Support Labeling Claim
Treatment Potential (TP)
P-Priority review drug: A drug that appears to represent an advance over available therapy
S-Standard review drug: A drug that appears to have therapeutic qualities similar to those of an already marketed drug.
Other Designations (may apply simultaneously)
AA AIDS drug: A drug indicated for treating AIDS or other HIV related disease.
E Subpart E drug: A drug developed or evaluated under special procedures for drugs to treat lifethreatening or severely debilitating illnesses. (The name refers to Title 21 of the Code of Federal Regulations, Part 312, Subpart E, which governs this classification. Also see, "The Evolution of U.S. Drug Law," page 26 of the booklet,  From Test Tube to Patient: NEW DRUG DEVELOPMENT IN THE UNITED STATES.)
V Designated orphan drug: A drug for which the sponsor received orphan designation under the Orphan Drug Act. Such a sponsor is eligible for tax credits and exclusive marketing rights for the drug.
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Date created: May 10, 2002; last updated; June 20, 2005 |
