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Drug Approvals for June 2000
Definitions and Notes
Original New Drug Applications
Original Application #: 020715
Approval Date: 15-JUN-00
Trade Name:TRELSTAR DEPOT
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: DEBIO RECHERCHE PHARMACEUTIQUE SA
Active Ingredient(s): TRIPTORELIN PAMOATE
OTC/RX Status: RX
Indication(s): For the palliative treatment of advanced prostate cancer
Efficacy Supplemental New Drug Applications
Application #: 020865 Efficacy Supplement #: 004
Type: SE8 to Original New Drug Application
Approval Date: 21-JUN-00
Trade Name: MAXALT
Dosage Form: TABLET
Applicant: MERCK & CO
Active Ingredient(s): RIZATRIPTAN BENZOATE
OTC/RX Status: RX
Efficacy Claim: Provide for the use of Maxalt Tablets and Maxalt-MLT in adolescent migraineurs
Application #: 050740 Efficacy Supplement #: 002
Type: SE1 to Original New Drug Application
Approval Date: 16-JUN-00
Trade Name: AMBISOME
Dosage Form: INJECTABLE, POWDER, LYOPHILIZED, FOR LIPOSOMAL SUSPENSION
Applicant: FUJISAWA HEALTHCARE INC
Active Ingredient(s): AMPHOTERICIN B
OTC/RX Status: RX
Efficacy Claim: For treatment of cryptococcal meningitis in HIV infected patients
Application #: 019898 Efficacy Supplement#: 031
Type: SE1 to Original New Drug Application
Approval Date: 09-JUN-00
Trade Name: PRAVACHOL
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB
Active Ingredient(s): PRAVASTATIN SODIUM
OTC/RX Status: RX
Efficacy Claim: Provides for the additional indication of increasing HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Frederickson Types Iia and IIb)
Application #: 020306 Efficacy Supplement #: 005
Type: SE1 to Original New Drug Application
Approval Date: 02-JUN-00
Trade Name: FLUDEOXYGLUCOSE F 18
Dosage Form: INJECTION
Applicant: DOWNSTATE CLINICAL PET CENTER
Active Ingredient(s): FLUDEOXYGLUCOSE, F-18
OTC/RX Status: RX
Efficacy Claim:
Approvable Original New Drug Applications
Original Application #: 021205
Approvable Date: 09-JUN-00
Trade Name: TRIZIVIR
Dosage Form: TABLET
Applicant: GLAXO WELLCOME
Active Ingredient(s):ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE)
OTC/RX Status: RX
Original Abbreviated Application # 065033
Approval Date: 27-JUN-00
Trade Name: BLEOMYCIN
Dosage Form: INJECTABLE
Applicant: GENSIA SICOR PHARMACEUTICALS, INC
Active Ingredient(s): BLEOMYCIN
OTC/RX Status: RX
Original Abbreviated Application # 074732
Approval Date: 26-JUN-00
Trade Name: TAMOXIFEN CITRATE
Dosage Form: TABLET
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): TAMOXIFEN CITRATE
OTC/RX Status: RX
Original Abbreviated Application # 075247
Approval Date: 23-JUN-00
Trade Name: MIDAZOLAM HCL
Dosage Form: INJECTABLE
Applicant: BEDFORD LABORATORIES
Active Ingredient(s): MIDAZOLAM HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075249
Approval Date: 23-JUN-00
Trade Name: MIDAZOLAM HCL
Dosage Form: INJECTABLE
Applicant: BEDFORD LABORATORIES
Active Ingredient(s): MIDAZOLAM HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 040368
Approval Date: 23-JUN-00
Trade Name: ORPHENADRINE CITRATE
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: IMPAX LABORATORIES
Active Ingredient(s): ORPHENADRINE CITRATE
OTC/RX Status: RX
Original Abbreviated Application # 075154
Approval Date: 20-JUN-00
Trade Name: MIDAZOLAM HYDROCHLORIDE
Dosage Form: INJECTABLE
Applicant: AESGEN INC
Active Ingredient(s): MIDAZOLAM HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075455
Approval Date: 20-JUN-00
Trade Name: MIDAZOLAM HCL
Dosage Form: INJECTABLE
Applicant: BEN VENUE LABORATORIES INC
Active Ingredient(s): MIDAZOLAM HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075484
Approval Date: 20-JUN-00
Trade Name: MIDAZOLAM HCL
Dosage Form: INJECTABLE
Applicant: FAULDING PHARMACEUTICAL CO
Active Ingredient(s): MIDAZOLAM HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075409
Approval Date: 20-JUN-00
Trade Name: MIDAZOLAM HCL
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): MIDAZOLAM HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075396
Approval Date: 20-JUN-00
Trade Name: MIDAZOLAM HCL
Dosage Form: INJECTABLE
Applicant: FAULDING PHARMACEUTICAL CO
Active Ingredient(s): MIDAZOLAM HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075324
Approval Date: 20-JUN-00
Trade Name: MIDAZOLAM HCL
Dosage Form: INJECTABLE
Applicant: BAXTER PHARMACEUTICAL PRODUCTS INC
Active Ingredient(s): MIDAZOLAM HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075293
Approval Date: 20-JUN-00
Trade Name: MIDAZOLAM
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): MIDAZOLAM HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075421
Approval Date: 20-JUN-00
Trade Name: MIDAZOLAM HCL
Dosage Form: INJECTABLE
Applicant: BEN VENUE LABORATORIES INC
Active Ingredient(s): MIDAZOLAM HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075243
Approval Date: 20-JUN-00
Trade Name: MIDAZOLAM HCL
Dosage Form: INJECTABLE
Applicant: ESI LEDERLE INC
Active Ingredient(s): MIDAZOLAM HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075263
Approval Date: 20-JUN-00
Trade Name: MIDAZOLAM HCL
Dosage Form: INJECTABLE
Applicant: ASTRAZENECA PHARMACEUTICALS, L.P.
Active Ingredient(s): MIDAZOLAM HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075448
Approval Date: 19-JUN-00
Trade Name: ISOSORBIDE MONONITRATE
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: ZENITH GOLDLINE PHARMACEUTICALS
Active Ingredient(s): ISOSORBIDE MONONITRATE
OTC/RX Status: RX
Original Abbreviated Application # 075549
Approval Date: 13-JUN-00
Trade Name: VECURONIUM BROMIDE
Dosage Form: INJECTABLE
Applicant: BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
Active Ingredient(s): VECURONIUM BROMIDE
OTC/RX Status: RX
Original Abbreviated Application # 040352
Approval Date: 13-JUN-00
Trade Name: MEPERIDINE HCL
Dosage Form: TABLET
Applicant: MALLINCKRODT INC
Active Ingredient(s): MEPERIDINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 040372
Approval Date: 08-JUN-00
Trade Name: PROMETHAZINE HCL
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES HOSP PRODUCTS DIV
Active Ingredient(s): PROMETHAZINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075179
Approval Date: 06-JUN-00
Trade Name: NABUMETONE
Dosage Form: TABLET, FILM COATED
Applicant: COPLEY PHARMACEUTICAL INC
Active Ingredient(s): NABUMETONE
OTC/RX Status: RX
Original Abbreviated and 505(b)(2) New Drug Applications with Tentative Approval
Labeling Supplements to Original New Drug Applications
Application #: 020864 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 21-JUN-00
Trade Name: MAXALT
Dosage Form: TABLET
Applicant: MERCK & CO
Active Ingredient(s):RIZATRIPTAN BENZOATE
OTC/RX Status: RX
Application #: 020406 Labeling Supplement#: 034
To Original New Drug Application
Approval Date: 20-JUN-00
Trade Name: PREVACID
Dosage Form: CAPSULE, EXTENDED RELEASE
Applicant: TAP PHARMACEUTICAL PRODUCTS INC
Active Ingredient(s): LANSOPRAZOLE
OTC/RX Status: RX
Application #: 019515 Labeling Supplement#: 014
To Original New Drug Application
Approval Date: 20-JUN-00
Trade Name: IONOSOL B AND DEXTROSE 5%
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): SODIUM LACTATE; SODIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC; DEXTROSE
OTC/RX Status: RX
Application #: 019513 Labeling Supplement#: 017
To Original New Drug Application
Approval Date: 20-JUN-00
Trade Name: IONOSOL MB AND DEXTROSE 5%
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): DEXTROSE; SODIUM LACTATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM PHOSPHATE, MONOBASIC
OTC/RX Status: RX
Application #: 017609 Labeling Supplement#: 107
To Original New Drug Application
Approval Date: 20-JUN-00
Trade Name: NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): DEXTROSE; SODIUM ACETATE; SODIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM GLUCONATE
OTC/RX Status: RX
Application #: 020593 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 19-JUN-00
Trade Name: DEPACON
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): VALPROATE SODIUM
OTC/RX Status: RX
Application #: 019680 Labeling Supplement#: 014
To Original New Drug Application
Approval Date: 19-JUN-00
Trade Name: DEPAKOTE
Dosage Form: CAPSULE
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): DIVALPROEX SODIUM
OTC/RX Status: RX
Application #: 018723 Labeling Supplement#: 028
To Original New Drug Application
Approval Date: 19-JUN-00
Trade Name: DEPAKOTE
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): DIVALPROEX SODIUM
OTC/RX Status: RX
Application #: 018082 Labeling Supplement#: 023
To Original New Drug Application
Approval Date: 19-JUN-00
Trade Name: DEPAKENE
Dosage Form: SYRUP
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): VALPROIC ACID
OTC/RX Status: RX
Application #: 018081 Labeling Supplement#: 032
To Original New Drug Application
Approval Date: 19-JUN-00
Trade Name: DEPAKENE
Dosage Form: CAPSULE
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): VALPROIC ACID
OTC/RX Status: RX
Application #: 018892 Labeling Supplement #: 018
To Original New Drug Application
Approval Date: 16-JUN-00
Trade Name: SODIUM PHOSPHATES IN PLASTIC CONTAINER
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES HOSP PRODUCTS DIV
Active Ingredient(s): SODIUM PHOSPHATE, MONOBASIC; SODIUM PHOSPHATE, DIBASIC
OTC/RX Status: RX
Application #: 018893 Labeling Supplement #: 013
To Original New Drug Application
Approval Date: 15-JUN-00
Trade Name: SODIUM ACETATE IN PLASTIC CONTAINER
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES HOSP PRODUCTS DIV
Active Ingredient(s): SODIUM ACETATE, ANHYDROUS
OTC/RX Status: RX
Application #: 018802 Labeling Supplement #: 013
To Original New Drug Application
Approval Date: 15-JUN-00
Trade Name: BACTERIOSTATIC WATER FOR INJECTION
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): WATER FOR INJECTION, STERILE
OTC/RX Status: RX
Application #: 018312 Labeling Supplement #: 012
To Original New Drug Application
Approval Date: 15-JUN-00
Trade Name: CALDEROL
Dosage Form: CAPSULE
Applicant: ORGANON INC SUB AKZONA INC
Active Ingredient(s): CALCIFEDIOL
OTC/RX Status: RX
Application #: 017609 Labeling Supplement #: 110
To Original New Drug Application
Approval Date: 15-JUN-00
Trade Name: NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): DEXTROSE; SODIUM ACETATE; SODIUM CHLORIDE; MAGN ESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM GLUCONATE
OTC/RX Status: RX
Application #: 017586 Labeling Supplement #: 107
To Original New Drug Application
Approval Date: 15-JUN-00
Trade Name: NORMOSOL-R IN PLASTIC CONTAINER
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): SODIUM GLUCONATE; SODIUM ACETATE; SODIUM CHLORI DE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE
OTC/RX Status: RX
Application #: 020838 Labeling Supplement #: 008
To Original New Drug Application
Approval Date: 14-JUN-00
Trade Name: ATACAND
Dosage Form: TABLET
Applicant: ASTRAZENECA LP
Active Ingredient(s): CANDESARTAN CILEXETIL
OTC/RX Status: RX
Application #: 020255 Labeling Supplement #: 006
To Original New Drug Application
Approval Date: 14-JUN-00
Trade Name: DOBUTAMINE HCL IN DEXTROSE 5%
Dosage Form: INJECTABLE
Applicant: BAXTER HEALTHCARE CORP
Active Ingredient(s): DOBUTAMINE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 019979 Labeling Supplement #: 019
To Original New Drug Application
Approval Date: 14-JUN-00
Trade Name: TICLID
Dosage Form: TABLET
Applicant: SYNTEX (USA) INC
Active Ingredient(s): TICLOPIDINE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 018233 Labeling Supplement #: 057
To Original New Drug Application
Approval Date: 14-JUN-00
Trade Name: STERILE WATER FOR INJECTION
Dosage Form: LIQUID
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): WATER FOR INJECTION, STERILE
OTC/RX Status: RX
Application #: 020068 Labeling Supplement #: 014
To Original New Drug Application
Approval Date: 13-JUN-00
Trade Name: FOSCAVIR
Dosage Form: INJECTABLE
Applicant: ASTRAZENECA LP
Active Ingredient(s): FOSCARNET SODIUM
OTC/RX Status: RX
Application #: 020068 Labeling Supplement #: 013
To Original New Drug Application
Approval Date: 13-JUN-00
Trade Name: FOSCAVIR
Dosage Form: INJECTABLE
Applicant: ASTRAZENECA LP
Active Ingredient(s): FOSCARNET SODIUM
OTC/RX Status: RX
Application #: 019091 Labeling Supplement #: 008
To Original New Drug Application
Approval Date: 13-JUN-00
Trade Name: ISMO
Dosage Form: TABLET
Applicant: AH ROBINS CO
Active Ingredient(s): ISOSORBIDE MONONITRATE
OTC/RX Status: RX
Application #: 050640 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 12-JUN-00
Trade Name: BACTOCILL
Dosage Form: INJECTABLE
Applicant: BAXTER HEALTHCARE CORP
Active Ingredient(s): OXACILLIN SODIUM
OTC/RX Status: RX
Application #: 020699 Labeling Supplement #: 012
To Original New Drug Application
Approval Date: 12-JUN-00
Trade Name: EFFEXOR XR
Dosage Form: CAPSULE, EXTENDED RELEASE
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): VENLAFAXINE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 020547 Labeling Supplement#: 013
To Original New Drug Application
Approval Date: 12-JUN-00
Trade Name: ACCOLATE
Dosage Form: TABLET
Applicant: ASTRAZENECA UK LTD
Active Ingredient(s): ZAFIRLUKAST
OTC/RX Status: RX
Application #: 018961 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 09-JUN-00
Trade Name: CHROMIC CHLORIDE
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES HOSP PRODUCTS DIV
Active Ingredient(s): CHROMIC CHLORIDE
OTC/RX Status: RX
Application #: 006823 Labeling Supplement#: 014
To Original New Drug Application
Approval Date: 09-JUN-00
Trade Name: AQUASOL A
Dosage Form: INJECTABLE
Applicant: ASTRAZENECA LP
Active Ingredient(s): VITAMIN A PALMITATE
OTC/RX Status: RX
Application #: 020388 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 08-JUN-00
Trade Name: NAVELBINE
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): VINORELBINE TARTRATE
OTC/RX Status: RX
Application #: 050682 Labeling Supplement#: 013
To Original New Drug Application
Approval Date: 07-JUN-00
Trade Name: COSMEGEN
Dosage Form: INJECTABLE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): DACTINOMYCIN
OTC/RX Status: RX
Application #: 021015 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 07-JUN-00
Trade Name: ANDROGEL
Dosage Form: GEL
Applicant: UNIMED PHARMACEUTICALS INC
Active Ingredient(s): TESTOSTERONE
OTC/RX Status: RX
Application #: 018985 Labeling Supplement #: 035
To Original New Drug Application
Approval Date: 06-JUN-00
Trade Name: ORTHO-NOVUM 7/7/7-21
Dosage Form: TABLET
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHA RMACEUTICAL CORP
Active Ingredient(s): NORETHINDRONE; ETHINYL ESTRADIOL; NORETHINDRONE ; ETHINYL ESTRADIOL; NORETHINDRONE; ETHINYL ESTRADIOL
OTC/RX Status: RX
Application #: 017919 Labeling Supplement #: 071
To Original New Drug Application
Approval Date: 06-JUN-00
Trade Name: NEOCON 28
Dosage Form: TABLET
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHA RMACEUTICAL CORP
Active Ingredient(s): NORETHINDRONE; ETHINYL ESTRADIOL
OTC/RX Status: RX
Application #: 017735 Labeling Supplement #: 089
To Original New Drug Application
Approval Date: 06-JUN-00
Trade Name: MODICON 28
Dosage Form: TABLET
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHA RMACEUTICAL CORP
Active Ingredient(s): NORETHINDRONE; ETHINYL ESTRADIOL
OTC/RX Status: RX
Application #: 050698 Labeling Supplement #: 011
To Original New Drug Application
Approval Date: 05-JUN-00
Trade Name: BIAXIN
Dosage Form: GRANULE, FOR RECONSTITUTION
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): CLARITHROMYCIN
OTC/RX Status: RX
Application #: 019697 Labeling Supplement #: 022
To Original New Drug Application
Approval Date: 05-JUN-00
Trade Name: ORTHO TRI-CYCLEN
Dosage Form: TABLET
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHA RMACEUTICAL CORP
Active Ingredient(s): ETHINYL ESTRADIOL; NORGESTIMATE; ETHINYL ESTRAD IOL; NORGESTIMATE; ETHINYL ESTRADIOL; NORGESTIMATE
OTC/RX Status: RX
Application #: 019653 Labeling Supplement #: 025
To Original New Drug Application
Approval Date: 05-JUN-00
Trade Name: ORTHO CYCLEN-21
Dosage Form: TABLET
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHA RMACEUTICAL CORP
Active Ingredient(s): NORGESTIMATE; ETHINYL ESTRADIOL
OTC/RX Status: RX
Application #: 016709 Labeling Supplement #: 126
To Original New Drug Application
Approval Date: 05-JUN-00
Trade Name: ORTHO-NOVUM 1/50 28
Dosage Form: TABLET
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHA RMACEUTICAL CORP
Active Ingredient(s): NORETHINDRONE; MESTRANOL
OTC/RX Status: RX
Application #: 020243 Labeling Supplement #: 020
To Original New Drug Application
Approval Date: 01-JUN-00
Trade Name: LUVOX
Dosage Form: TABLET
Applicant: SOLVAY PHARMACEUTICALS
Active Ingredient(s): FLUVOXAMINE MALEATE
OTC/RX Status: RX
Application #: 020243 Labeling Supplement #: 019
To Original New Drug Application
Approval Date: 01-JUN-00
Trade Name: LUVOX
Dosage Form: TABLET
Applicant: SOLVAY PHARMACEUTICALS
Active Ingredient(s): FLUVOXAMINE MALEATE
OTC/RX Status: RX
Application #: 020243 Labeling Supplement #: 014
To Original New Drug Application
Approval Date: 01-JUN-00
Trade Name: LUVOX
Dosage Form: TABLET
Applicant: SOLVAY PHARMACEUTICALS
Active Ingredient(s): FLUVOXAMINE MALEATE
OTC/RX Status: RX
Application #: 020243 Labeling Supplement #: 013
To Original New Drug Application
Approval Date: 01-JUN-00
Trade Name: LUVOX
Dosage Form: TABLET
Applicant: SOLVAY PHARMACEUTICALS
Active Ingredient(s): FLUVOXAMINE MALEATE
OTC/RX Status: RX
Application #: 018821 Labeling Supplement #: 016
To Original New Drug Application
Approval Date: 01-JUN-00
Trade Name: REGLAN
Dosage Form: SOLUTION
Applicant: AH ROBINS CO
Active Ingredient(s): METOCLOPRAMIDE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 017862 Labeling Supplement #: 040
To Original New Drug Application
Approval Date: 01-JUN-00
Trade Name: REGLAN
Dosage Form: INJECTION
Applicant: AH ROBINS CO
Active Ingredient(s): METOCLOPRAMIDE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 017854 Labeling Supplement #: 037
To Original New Drug Application
Approval Date: 01-JUN-00
Trade Name: REGLAN
Dosage Form: TABLET
Applicant: AH ROBINS CO
Active Ingredient(s): METOCLOPRAMIDE HYDROCHLORIDE
OTC/RX Status: RX
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Date created: March 08, 2001; last update: June 20, 2005 |
