Drug Approvals for June 2002

Definitions and Notes

Original New Drug Applications

Original Application # 021316
Approval Date: 26-JUN-02
Trade Name: ALTOCOR
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: AURA LABORATORIES INC
Active Ingredient(s): LOVASTATIN
OTC/RX Status: RX
INDICATION OF USE: For lowering total cholesterol and LDL-C to target levels as an adjunct to diet and exercise, to slow the progression of atherosclerosis in patients with coronary heart disease, and to reduce Total-C, LDL-C, Apo B and triglycerides and to increase HDL-C in patients with Fredrickson types IIa and IIb dyslipoproteinemia

Original Application # 021312
Approval Date: 26-JUN-02
Trade Name: CLARINEX REDITABS
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: SCHERING CORP
Active Ingredient(s): DESLORATADINE
OTC/RX Status: RX
INDICATION OF USE: For the relief of nasal and non-nasal symptoms of allergic rhinitis (seasonal and perennial) in patients 12 years of age and older; for the symptomatic relief of pruritus, reduction in the number of hives, and size of hives, in patients with chronic idiopathic urticaria 12 years of age and older

Original Application # 020919
Approval Date: 21-JUN-02
Trade Name: GEODON
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: PFIZER CENTRAL RESEARCH
Active Ingredient(s): ZIPRASIDONE MESYLATE
OTC/RX Status: RX
INDICATION OF USE: For the treatment of acute agitation in schizophrenic patients for whom treatment with ziprasidone is appropriate and who need intramuscular antipsychotic medication for rapid control of the agitation

Original Application #: 021212
Approval Date: 11-JUN-02
Trade Name: CAVERJECT DC
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): ALPROSTADIL
OTC/RX Status: RX
Indication(s): For the treatment of erectile dysfunction

Original Application #: 021284
Approval Date: 05-JUN-02
Trade Name: RITALIN
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: CAPSULE, EXTENDED RELEASE
Applicant: NOVARTIS PHARMACEUTICALS CORP DBA GEIGY PHARMACEUTICALS DIV
Active Ingredient(s): METHYLPHENIDATE HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): For the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) for children aged 6 to 12

Efficacy Supplemental New Drug Applications

Application #: 020596 Efficacy Supplement #: 016
Type: SE2 to Original New Drug Application
Approval Date: 24-JUN-02
Trade Name: EPIVIR
Dosage Form: SOLUTION
Applicant: GLAXOSMITHKLINE
Active Ingredient(s): LAMIVUDINE
OTC/RX Status: RX
Efficacy Claim: For the treatment of HIV infection in combination with other antiretroviral agents

Application #: 020564 Efficacy Supplement #: 015
Type: SE2 to Original New Drug Application
Approval Date: 24-JUN-02
Trade Name: EPIVIR
Dosage Form: TABLET
Applicant: GLAXOSMITHKLINE
Active Ingredient(s): LAMIVUDINE
OTC/RX Status: RX
Efficacy Claim: For the treatment of HIV infection in combination with other antiretroviral agents

Application #: 020992 Efficacy Supplement #: 016
Type: SE1 to Original New Drug Application
Approval Date: 21-JUN-02
Trade Name: CENESTIN
Dosage Form: TABLET
Applicant: BARR LABORATORIES
Active Ingredient(s): ESTROGENS, CONJUGATED SYNTHETIC A
OTC/RX Status: RX
Efficacy Claim: For the treatment of vulvar and vaginal atrophy associated with menopause

Application #: 018936 Efficacy Supplement #: 067
Type: SE2 to Original New Drug Application
Approval Date: 12-JUN-02
Trade Name: SARAFEM
Dosage Form: CAPSULE
Applicant: LILLY RESEARCH LABORATORIES DIV ELI LILLY AND CO
Active Ingredient(s): FLUOXETINE HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim: In the treatment of premenstrual dysphoric disorder (PMDD), using an intermittent dosing regimen, as an alternative to the currently approved continuous dosing regimen

Application #: 020998 Efficacy Supplement #: 009
Type: SE8 to Original New Drug Application
Approval Date: 07-JUN-02
Trade Name: CELEBREX
Dosage Form: CAPSULE
Applicant: GD SEARLE LLC
Active Ingredient(s): CELECOXIB
OTC/RX Status: RX
Efficacy Claim: For relief of the signs and symptoms of osteoarthritis; for the relief of signs and symptoms of rheumatoid arthritis in adults; for the management of acute pain in adults; for the treatment of primary dysmenorrhea; to reduce the number of adenomatrous colorectal polyps in familial adenomatous polyposis (FAP, as an adjunct to usual care

Approvable Original New Drug Applications

Original Abbreviated New Drug Applications

Original Abbreviated Application # 076257
Approval Date: 27-JUN-02
Trade Name: GLYBURIDE
Dosage Form: TABLET
Applicant: COREPHARMA LLC
Active Ingredient(s): GLYBURIDE
OTC/RX Status: RX

Original Abbreviated Application # 075983
Approval Date: 25-JUN-02
Trade Name: TRAMADOL HCL
Dosage Form: TABLET, FILM COATED
Applicant: MALLINCKRODT INC
Active Ingredient(s): TRAMADOL HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075968
Approval Date: 25-JUN-02
Trade Name: TRAMADOL HCL
Dosage Form: TABLET
Applicant: EON LABORATORIES MANUFACTURING INC
Active Ingredient(s): TRAMADOL HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075962
Approval Date: 24-JUN-02
Trade Name: TRAMADOL HCL
Dosage Form: TABLET
Applicant: WATSON LABORATORIES
Active Ingredient(s): TRAMADOL HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075986
Approval Date: 21-JUN-02
Trade Name: TRAMADOL HCL
Dosage Form: TABLET
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): TRAMADOL HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 076100
Approval Date: 20-JUN-02
Trade Name: TRAMADOL HCL
Dosage Form: TABLET
Applicant: MUTUAL PHARMACEUTICAL CO INC
Active Ingredient(s): TRAMADOL HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 076003
Approval Date: 20-JUN-02
Trade Name: TRAMADOL HCL
Dosage Form: TABLET
Applicant: COREPHARMA LLC
Active Ingredient(s): TRAMADOL HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075977
Approval Date: 19-JUN-02
Trade Name: TRAMADOL HCL
Dosage Form: TABLET
Applicant: TEVA PHARMACEUTICALS USA INC
Active Ingredient(s): TRAMADOL HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated New Drug Applications

Original Abbreviated Application # 075964
Approval Date: 19-JUN-02
Trade Name: TRAMADOL HCL
Dosage Form: TABLET
Applicant: CARACO PHARMACEUTICAL LABORATORIES LTD
Active Ingredient(s): TRAMADOL HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075960
Approval Date: 19-JUN-02
Trade Name: TRAMADOL HCL
Dosage Form: TABLET
Applicant: PUREPAC PHARMACEUTICAL CO
Active Ingredient(s): TRAMADOL HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075856
Approval Date: 13-JUN-02
Trade Name: MIDAZOLAM HCL
Dosage Form: INJECTABLE
Applicant: ROSS LABORATORIES DIV ABBOTT LABORATORIES
Active Ingredient(s): MIDAZOLAM HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075589
Approval Date: 11-JUN-02
Trade Name: TRETINOIN
Dosage Form: GEL
Applicant: SPEAR PHARMACEUTICALS INC
Active Ingredient(s): TRETINOIN
OTC/RX Status: RX

Original Abbreviated Application # 075575
Approval Date: 11-JUN-02
Trade Name: AMMONIUM LACTATE
Dosage Form: LOTION
Applicant: PADDOCK LABORATORIES INC
Active Ingredient(s): AMMONIUM LACTATE
OTC/RX Status: RX

Original Abbreviated Application # 076170
Approval Date: 10-JUN-02
Trade Name: LITHIUM CARBONATE
Dosage Form: TABLET, SUSTAINED ACTION
Applicant: BARR LABORATORIES INC
Active Ingredient(s): LITHIUM CARBONATE
OTC/RX Status: RX

Original Abbreviated Application # 076187
Approval Date: 05-JUN-02
Trade Name: LEVOTHYROXINE SODIUM
Dosage Form: TABLET
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): LEVOTHYROXINE SODIUM
OTC/RX Status: RX

Original Abbreviated Application # 075991
Approval Date: 05-JUN-02
Trade Name: LOVASTATIN
Dosage Form: TABLET
Applicant: CARLSBAD TECHNOLOGY INC
Active Ingredient(s): LOVASTATIN
OTC/RX Status: RX

Original Abbreviated Application # 075714
Approval Date: 05-JUN-02
Trade Name: CARBAMAZEPINE
Dosage Form: SUSPENSION
Applicant: MORTON GROVE PHARMACEUTICALS INC
Active Ingredient(s): CARBAMAZEPINE
OTC/RX Status: RX

Original Abbreviated Antibiotic Application # 065066
Approval Date: 05-JUN-02
Trade Name: AMOXICILLIN AND CLAVULANATE POTASSIUM
Dosage Form: SUSPENSION
Applicant: GENEVA PHARMACEUTICALS INC
Active Ingredient(s): AMOXICILLIN; CLAVULANATE POTASSIUM
OTC/RX Status: RX

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

Original Abbreviated Application #: 076127
Tentative Approval Date: 26-JUN-02
Trade Name: LORATADINE
Dosage Form: SYRUP
Applicant: TARO PHARMACEUTICAL INDUSTRIES LTD
Active Ingredient(s): LORATADINE
OTC/RX Status: RX

Labeling Supplements to Original New Drug Applications

Application #: 020123 Labeling Supplement #: 022
To Original New Drug Application
Approval Date: 28-JUN-02
Trade Name: OMNISCAN
Dosage Form: INJECTABLE
Applicant: AMERSHAM HEALTH
Active Ingredient(s): GADODIAMIDE
OTC/RX Status: RX

Application #: 011529 Labeling Supplement #: 048
To Original New Drug Application
Approval Date: 28-JUN-02
Trade Name: PARAFON
Dosage Form: TABLET
Applicant: MCNEIL CONSUMER PRODUCTS COMPANY
Active Ingredient(s): CHLORZOXAZONE
OTC/RX Status: RX

Application #: 020326 Labeling Supplement #: 013
To Original New Drug Application
Approval Date: 26-JUN-02
Trade Name: NEUTREXIN
Dosage Form: INJECTABLE
Applicant: MEDIMMUNE ONCOLOGY INC
Active Ingredient(s): TRIMETREXATE GLUCURONATE
OTC/RX Status: RX

Application #: 020326 Labeling Supplement #: 011
To Original New Drug Application
Approval Date: 26-JUN-02
Trade Name: NEUTREXIN
Dosage Form: INJECTABLE
Applicant: MEDIMMUNE ONCOLOGY INC
Active Ingredient(s): TRIMETREXATE GLUCURONATE
OTC/RX Status: RX

Application #: 020628 Labeling Supplement #: 016
To Original New Drug Application
Approval Date: 24-JUN-02
Trade Name: INVIRASE
Dosage Form: CAPSULE
Applicant: HLR TECHNOLOGY
Active Ingredient(s): SAQUINAVIR MESYLATE
OTC/RX Status: RX

Application #: 020873 Labeling Supplement #: 004
To Original New Drug Application
Approval Date: 20-JUN-02
Trade Name: ANGIOMAX
Dosage Form: INJECTABLE
Applicant: MEDICINES CO (TMC)
Active Ingredient(s): BIVALIRUDIN
OTC/RX Status: RX

Application #: 020685 Labeling Supplement #: 056
To Original New Drug Application
Approval Date: 20-JUN-02
Trade Name: CRIXIVAN
Dosage Form: CAPSULE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): INDINAVIR SULFATE
OTC/RX Status: RX

Application #: 020358 Labeling Supplement #: 023
To Original New Drug Application
Approval Date: 20-JUN-02
Trade Name: WELLBUTRIN SR
Dosage Form: TABLET
Applicant: GLAXOSMITHKLINE
Active Ingredient(s): BUPROPION HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020358 Labeling Supplement #: 018
To Original New Drug Application
Approval Date: 20-JUN-02
Trade Name: WELLBUTRIN SR
Dosage Form: TABLET
Applicant: GLAXOSMITHKLINE
Active Ingredient(s): BUPROPION HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020152 Labeling Supplement #: 033
To Original New Drug Application
Approval Date: 20-JUN-02
Trade Name: SERZONE
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): NEFAZODONE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 019615 Labeling Supplement #: 017
To Original New Drug Application
Approval Date: 20-JUN-02
Trade Name: DOPAMINE HCL IN DEXTROSE 5%
Dosage Form: INJECTABLE
Applicant: BAXTER HEALTHCARE CORP
Active Ingredient(s): DOPAMINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 018662 Labeling Supplement #: 051
To Original New Drug Application
Approval Date: 20-JUN-02
Trade Name: ACCUTANE
Dosage Form: CAPSULE
Applicant: HLR TECHNOLOGY
Active Ingredient(s): ISOTRETINOIN
OTC/RX Status: RX

Application #: 018644 Labeling Supplement #: 023
To Original New Drug Application
Approval Date: 20-JUN-02
Trade Name: WELLBUTRIN
Dosage Form: TABLET
Applicant: GLAXOSMITHKLINE
Active Ingredient(s): BUPROPION HYDROCHLORIDE
OTC/RX Status: RX

Application #: 018644 Labeling Supplement #: 022
To Original New Drug Application
Approval Date: 20-JUN-02
Trade Name: WELLBUTRIN
Dosage Form: TABLET
Applicant: GLAXOSMITHKLINE
Active Ingredient(s): BUPROPION HYDROCHLORIDE
OTC/RX Status: RX

Application #: 013217 Labeling Supplement #: 044
To Original New Drug Application
Approval Date: 20-JUN-02
Trade Name: SKELAXIN
Dosage Form: TABLET
Applicant: ELAN PHARMACEUTICALS, INC
Active Ingredient(s): METAXALONE
OTC/RX Status: RX

Application #: 012583 Labeling Supplement #: 028
To Original New Drug Application
Approval Date: 20-JUN-02
Trade Name: OPHTHETIC
Dosage Form: SOLUTION
Applicant: ALLERGAN PHARMACEUTICAL
Active Ingredient(s): PROPARACAINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 050641 Labeling Supplement #: 010
To Original New Drug Application
Approval Date: 18-JUN-02
Trade Name: MONODOX
Dosage Form: CAPSULE
Applicant: WATSON LABORATORIES, INC
Active Ingredient(s): DOXYCYCLINE
OTC/RX Status: RX

Application #: 050582 Labeling Supplement #: 016
To Original New Drug Application
Approval Date: 18-JUN-02
Trade Name: DORYX
Dosage Form: CAPSULE
Applicant: FH FAULDING AND CO LTD
Active Ingredient(s): DOXYCYCLINE HYCLATE
OTC/RX Status: RX

Application #: 050533 Labeling Supplement #: 030
To Original New Drug Application
Approval Date: 18-JUN-02
Trade Name: VIBRA-TABS
Dosage Form: TABLET
Applicant: PFIZER LABORATORIES DIV PFIZER INC
Active Ingredient(s): DOXYCYCLINE HYCLATE
OTC/RX Status: RX

Application #: 050480 Labeling Supplement #: 035
To Original New Drug Application
Approval Date: 18-JUN-02
Trade Name: VIBRAMYCIN
Dosage Form: SYRUP
Applicant: PFIZER LABORATORIES DIV PFIZER INC
Active Ingredient(s): DOXYCYCLINE CALCIUM
OTC/RX Status: RX

Application #: 050442 Labeling Supplement #: 015
To Original New Drug Application
Approval Date: 18-JUN-02
Trade Name: VIBRAMYCIN
Dosage Form: INJECTABLE
Applicant: PFIZER LABORATORIES DIV PFIZER INC
Active Ingredient(s): DOXYCYCLINE HYCLATE
OTC/RX Status: RX

Application #: 050007 Labeling Supplement #: 014
To Original New Drug Application
Approval Date: 18-JUN-02
Trade Name: VIBRAMYCIN
Dosage Form: CAPSULE
Applicant: PFIZER LABORATORIES DIV PFIZER INC
Active Ingredient(s): DOXYCYCLINE HYCLATE
OTC/RX Status: RX

Application #: 050006 Labeling Supplement #: 074
To Original New Drug Application
Approval Date: 18-JUN-02
Trade Name: VIBRAMYCIN
Dosage Form: SUSPENSION
Applicant: PFIZER LABORATORIES DIV PFIZER INC
Active Ingredient(s): DOXYCYCLINE
OTC/RX Status: RX

Application #: 020610 Labeling Supplement #: 001
To Original New Drug Application
Approval Date: 18-JUN-02
Trade Name: COLAZAL
Dosage Form: CAPSULE
Applicant: SALIX PHARMACEUTICALS INC
Active Ingredient(s): BALSALAZIDE DISODIUM
OTC/RX Status: RX

Application #: 020913 Labeling Supplement #: 009
To Original New Drug Application
Approval Date: 17-JUN-02
Trade Name: AGGRASTAT
Dosage Form: INJECTABLE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): TIROFIBAN HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020912 Labeling Supplement #: 012
To Original New Drug Application
Approval Date: 17-JUN-02
Trade Name: AGGRASTAT
Dosage Form: INJECTABLE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): TIROFIBAN HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020485 Labeling Supplement #: 005
To Original New Drug Application
Approval Date: 14-JUN-02
Trade Name: VISINE-A
Dosage Form: SOLUTION, DROPS
Applicant: PFIZER INC
Active Ingredient(s): PHENIRAMINE MALEATE; NAPHAZOLINE HYDROCHLORIDE
OTC/RX Status: OTC

Application #: 020367 Labeling Supplement #: 053
To Original New Drug Application
Approval Date: 14-JUN-02
Trade Name: CEREZYME
Dosage Form: INJECTABLE
Applicant: GENZYME CORP
Active Ingredient(s): IMIGLUCERASE
OTC/RX Status: RX

Application #: 020130 Labeling Supplement #: 009
To Original New Drug Application
Approval Date: 14-JUN-02
Trade Name: ESTROSTEP 21
Dosage Form: TABLET
Applicant: PFIZER INC
Active Ingredient(s): NORETHINDRONE ACETATE; ETHINYL ESTRADIOL; NORET HINDRONE ACETATE; ETHINYL ESTRADIOL; NORETHINDRONE ACETATE; ETHINYL ESTRADIOL
OTC/RX Status: RX

Application #: 019722 Labeling Supplement #: 004
To Original New Drug Application
Approval Date: 14-JUN-02
Trade Name: NASCOBAL
Dosage Form: GEL
Applicant: NASTECH PHARMACEUTICAL CO INC
Active Ingredient(s): CYANOCOBALAMIN
OTC/RX Status: RX

Application #: 020815 Labeling Supplement #: 010
To Original New Drug Application
Approval Date: 13-JUN-02
Trade Name: EVISTA
Dosage Form: TABLET
Applicant: ELI LILLY AND CO
Active Ingredient(s): RALOXIFENE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 050716 Labeling Supplement #: 018
To Original New Drug Application
Approval Date: 12-JUN-02
Trade Name: NEORAL
Dosage Form: SOLUTION
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): CYCLOSPORINE
OTC/RX Status: RX

Application #: 050716 Labeling Supplement #: 014
To Original New Drug Application
Approval Date: 12-JUN-02
Trade Name: NEORAL
Dosage Form: SOLUTION
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): CYCLOSPORINE
OTC/RX Status: RX

Application #: 050715 Labeling Supplement #: 014
To Original New Drug Application
Approval Date: 12-JUN-02
Trade Name: NEORAL
Dosage Form: CAPSULE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): CYCLOSPORINE
OTC/RX Status: RX

Application #: 050715 Labeling Supplement #: 010
To Original New Drug Application
Approval Date: 12-JUN-02
Trade Name: NEORAL
Dosage Form: CAPSULE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): CYCLOSPORINE
OTC/RX Status: RX

Application #: 021277 Labeling Supplement #: 002
To Original New Drug Application
Approval Date: 12-JUN-02
Trade Name: AVELOX IN SODIUM CHLORIDE 0.8%
Dosage Form: INJECTABLE
Applicant: BAYER CORP PHARMACEUTICAL DIV
Active Ingredient(s): MOXIFLOXACIN HYDROCHLORIDE
OTC/RX Status: RX

Application #: 021085 Labeling Supplement #: 007
To Original New Drug Application
Approval Date: 12-JUN-02
Trade Name: AVELOX
Dosage Form: TABLET
Applicant: BAYER CORP PHARMACEUTICAL DIV
Active Ingredient(s): MOXIFLOXACIN HYDROCHLORIDE
OTC/RX Status: RX

Application #: 021085 Labeling Supplement #: 006
To Original New Drug Application
Approval Date: 12-JUN-02
Trade Name: AVELOX
Dosage Form: TABLET
Applicant: BAYER CORP PHARMACEUTICAL DIV
Active Ingredient(s): MOXIFLOXACIN HYDROCHLORIDE
OTC/RX Status: RX

Application #: 017766 Labeling Supplement #: 028
To Original New Drug Application
Approval Date: 12-JUN-02
Trade Name: NEPHRAMINE 5.4%
Dosage Form: INJECTABLE
Applicant: B BRAUN MEDICAL INC
Active Ingredient(s): AMINO ACIDS
OTC/RX Status: RX

Application #: 020511 Labeling Supplement #: 002
To Original New Drug Application
Approval Date: 11-JUN-02
Trade Name: APHTHASOL
Dosage Form: PASTE
Applicant: GLAXOSMITHKLINE
Active Ingredient(s): AMLEXANOX
OTC/RX Status: RX

Application #: 020747 Labeling Supplement #: 011
To Original New Drug Application
Approval Date: 10-JUN-02
Trade Name: ACTIQ
Dosage Form: TABLET; TROCHE
Applicant: CEPHALON INC
Active Ingredient(s): FENTANYL CITRATE
OTC/RX Status: RX

Application #: 020237 Labeling Supplement #: 009
To Original New Drug Application
Approval Date: 10-JUN-02
Trade Name: SALAGEN
Dosage Form: TABLET
Applicant: MGI PHARMA INC
Active Ingredient(s): PILOCARPINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020237 Labeling Supplement #: 008
To Original New Drug Application
Approval Date: 10-JUN-02
Trade Name: SALAGEN
Dosage Form: TABLET
Applicant: MGI PHARMA INC
Active Ingredient(s): PILOCARPINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 019049 Labeling Supplement #: 011
To Original New Drug Application
Approval Date: 10-JUN-02
Trade Name: RETIN-A
Dosage Form: EMULSION, CREAM
Applicant: JOHNSON AND JOHNSON CONSUMER COMPANIES INC
Active Ingredient(s): TRETINOIN
OTC/RX Status: RX

Application #: 019049 Labeling Supplement #: 008
To Original New Drug Application
Approval Date: 10-JUN-02
Trade Name: RETIN-A
Dosage Form: EMULSION, CREAM
Applicant: JOHNSON AND JOHNSON CONSUMER COMPANIES INC
Active Ingredient(s): TRETINOIN
OTC/RX Status: RX

Application #: 019049 Labeling Supplement #: 007
To Original New Drug Application
Approval Date: 10-JUN-02
Trade Name: RETIN-A
Dosage Form: EMULSION, CREAM
Applicant: JOHNSON AND JOHNSON CONSUMER COMPANIES INC
Active Ingredient(s): TRETINOIN
OTC/RX Status: RX

Application #: 017955 Labeling Supplement #: 023
To Original New Drug Application
Approval Date: 10-JUN-02
Trade Name: RETIN-A
Dosage Form: GEL
Applicant: JOHNSON AND JOHNSON CONSUMER COMPANIES INC
Active Ingredient(s): TRETINOIN
OTC/RX Status: RX

Application #: 017955 Labeling Supplement #: 020
To Original New Drug Application
Approval Date: 10-JUN-02
Trade Name: RETIN-A
Dosage Form: GEL
Applicant: JOHNSON AND JOHNSON CONSUMER COMPANIES INC
Active Ingredient(s): TRETINOIN
OTC/RX Status: RX

Application #: 017955 Labeling Supplement #: 019
To Original New Drug Application
Approval Date: 10-JUN-02
Trade Name: RETIN-A
Dosage Form: GEL
Applicant: JOHNSON AND JOHNSON CONSUMER COMPANIES INC
Active Ingredient(s): TRETINOIN
OTC/RX Status: RX

Application #: 017579 Labeling Supplement #: 023
To Original New Drug Application
Approval Date: 10-JUN-02
Trade Name: RETIN-A
Dosage Form: GEL
Applicant: JOHNSON AND JOHNSON CONSUMER COMPANIES INC
Active Ingredient(s): TRETINOIN
OTC/RX Status: RX

Application #: 017579 Labeling Supplement #: 020
To Original New Drug Application
Approval Date: 10-JUN-02
Trade Name: RETIN-A
Dosage Form: GEL
Applicant: JOHNSON AND JOHNSON CONSUMER COMPANIES INC
Active Ingredient(s): TRETINOIN
OTC/RX Status: RX

Application #: 017579 Labeling Supplement #: 018
To Original New Drug Application
Approval Date: 10-JUN-02
Trade Name: RETIN-A
Dosage Form: GEL
Applicant: JOHNSON AND JOHNSON CONSUMER COMPANIES INC
Active Ingredient(s): TRETINOIN
OTC/RX Status: RX

Application #: 017522 Labeling Supplement #: 026
To Original New Drug Application
Approval Date: 10-JUN-02
Trade Name: RETIN-A
Dosage Form: EMULSION, CREAM
Applicant: JOHNSON AND JOHNSON CONSUMER COMPANIES INC
Active Ingredient(s): TRETINOIN
OTC/RX Status: RX

Application #: 017522 Labeling Supplement #: 023
To Original New Drug Application
Approval Date: 10-JUN-02
Trade Name: RETIN-A
Dosage Form: EMULSION, CREAM
Applicant: JOHNSON AND JOHNSON CONSUMER COMPANIES INC
Active Ingredient(s): TRETINOIN
OTC/RX Status: RX

Application #: 017522 Labeling Supplement #: 022
To Original New Drug Application
Approval Date: 10-JUN-02
Trade Name: RETIN-A
Dosage Form: EMULSION, CREAM
Applicant: JOHNSON AND JOHNSON CONSUMER COMPANIES INC
Active Ingredient(s): TRETINOIN
OTC/RX Status: RX

Application #: 017340 Labeling Supplement #: 036
To Original New Drug Application
Approval Date: 10-JUN-02
Trade Name: RETIN-A
Dosage Form: EMULSION, CREAM
Applicant: JOHNSON AND JOHNSON CONSUMER COMPANIES INC
Active Ingredient(s): TRETINOIN
OTC/RX Status: RX

Application #: 017340 Labeling Supplement #: 033
To Original New Drug Application
Approval Date: 10-JUN-02
Trade Name: RETIN-A
Dosage Form: EMULSION, CREAM
Applicant: JOHNSON AND JOHNSON CONSUMER COMPANIES INC
Active Ingredient(s): TRETINOIN
OTC/RX Status: RX

Application #: 017340 Labeling Supplement #: 032
To Original New Drug Application
Approval Date: 10-JUN-02
Trade Name: RETIN-A
Dosage Form: EMULSION, CREAM
Applicant: JOHNSON AND JOHNSON CONSUMER COMPANIES INC
Active Ingredient(s): TRETINOIN
OTC/RX Status: RX

Application #: 016921 Labeling Supplement #: 025
To Original New Drug Application
Approval Date: 10-JUN-02
Trade Name: RETIN-A
Dosage Form: SOLUTION
Applicant: JOHNSON AND JOHNSON CONSUMER COMPANIES INC
Active Ingredient(s): TRETINOIN
OTC/RX Status: RX

Application #: 016921 Labeling Supplement #: 022
To Original New Drug Application
Approval Date: 10-JUN-02
Trade Name: RETIN-A
Dosage Form: SOLUTION
Applicant: JOHNSON AND JOHNSON CONSUMER COMPANIES INC
Active Ingredient(s): TRETINOIN
OTC/RX Status: RX

Application #: 016921 Labeling Supplement #: 021
To Original New Drug Application
Approval Date: 10-JUN-02
Trade Name: RETIN-A
Dosage Form: SOLUTION
Applicant: JOHNSON AND JOHNSON CONSUMER COMPANIES INC
Active Ingredient(s): TRETINOIN
OTC/RX Status: RX

Application #: 020955 Labeling Supplement #: 005
To Original New Drug Application
Approval Date: 07-JUN-02
Trade Name: FERRLECIT
Dosage Form: INJECTABLE
Applicant: WATSON LABORATORIES INC
Active Ingredient(s): SODIUM FERRIC GLUCONATE COMPLEX
OTC/RX Status: RX

Application #: 050662 Labeling Supplement #: 031
To Original New Drug Application
Approval Date: 06-JUN-02
Trade Name: BIAXIN
Dosage Form: TABLET
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): CLARITHROMYCIN
OTC/RX Status: RX

Application #: 050662 Labeling Supplement #: 030
To Original New Drug Application
Approval Date: 06-JUN-02
Trade Name: BIAXIN
Dosage Form: TABLET
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): CLARITHROMYCIN
OTC/RX Status: RX

Application #: 021205 Labeling Supplement #: 004
To Original New Drug Application
Approval Date: 04-JUN-02
Trade Name: TRIZIVIR
Dosage Form: TABLET
Applicant: GLAXOSMITHKLINE
Active Ingredient(s): ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE
OTC/RX Status: RX

Application #: 021205 Labeling Supplement #: 003
To Original New Drug Application
Approval Date: 04-JUN-02
Trade Name: TRIZIVIR
Dosage Form: TABLET
Applicant: GLAXOSMITHKLINE
Active Ingredient(s): ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE
OTC/RX Status: RX

Application #: 020978 Labeling Supplement #: 007
To Original New Drug Application
Approval Date: 04-JUN-02
Trade Name: ZIAGEN
Dosage Form: SOLUTION
Applicant: GLAXOSMITHKLINE
Active Ingredient(s): ABACAVIR SULFATE
OTC/RX Status: RX

Application #: 020977 Labeling Supplement #: 006
To Original New Drug Application
Approval Date: 04-JUN-02
Trade Name: ZIAGEN
Dosage Form: TABLET
Applicant: GLAXOSMITHKLINE
Active Ingredient(s): ABACAVIR SULFATE
OTC/RX Status: RX

Application #: 009000 Labeling Supplement #: 023
To Original New Drug Application
Approval Date: 04-JUN-02
Trade Name: CAFERGOT
Dosage Form: SUPPOSITORY
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): ERGOTAMINE TARTRATE; CAFFEINE
OTC/RX Status: RX

Application #: 009000 Labeling Supplement #: 022
To Original New Drug Application
Approval Date: 04-JUN-02
Trade Name: CAFERGOT
Dosage Form: SUPPOSITORY
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): ERGOTAMINE TARTRATE; CAFFEINE
OTC/RX Status: RX

Application #: 008809 Labeling Supplement #: 046
To Original New Drug Application
Approval Date: 04-JUN-02
Trade Name: M.V.I.
Dosage Form: INJECTABLE
Applicant: NEOSAN PHARMACEUTICALS
Active Ingredient(s): ASCORBIC ACID; VITAMIN D; THIAMINE HYDROCHLORID E; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; DEXPANTHENOL; VITAMIN E; V ITAMIN A
OTC/RX Status: RX

Definitions

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

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.