Drug Approvals for October 1999

Definitions and Notes

Original New Drug Applications

Original Application #: 021087
Approval Date: 27-OCT-99
Trade Name: TAMIFLU
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: CAPSULE
Applicant: HOFFMANN LA ROCHE INC
Active Ingredient(s): OSELTAMIVIR PHOSPHATE
OTC/RX Status: RX
Indication(s): For the treatment of uncomplicated acute illness due to influenza infections in adults who have been symptomatic for no more than two days

Original Application #: 021040
Approval Date: 22-OCT-99
Trade Name: ORTHO-PREFEST
Chemical Type:
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): ESTRADIOL; ESDTRADIOL/NORGESTIMATE
OTC/RX Status: RX
Indication(s): For the treatment of moderate-to-severe vasomotor symptoms associated with the menopause; treatment of vulvar and vaginal atrophy, and prevention of osteoporosis

Original Application #: 020753
Approval Date: 21-OCT-99
Trade Name: AROMASIN
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): EXEMESTANE
OTC/RX Status: RX
Indication(s): For the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy

Original Application #: 020796
Approval Date: 19-OCT-99
Trade Name: COMTAN
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: ORION CORP
Active Ingredient(s): ENTACAPONE
OTC/RX Status: RX
Indication(s): For the use of Comtan as an adjunct to levodopa/carbidopa to treat patients with idiopathic Parkinson’s Disease who experience the signs and symptoms of end-of-dose “wearing-off” (so-called “fluctuating” patients)

Original Application #: 021065
Approval Date: 15-OCT-99
Trade Name: FEMHRT
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: PARKE DAVIS PHARMACEUTICAL RESEARCH DIV WARNER LAMBERT CO
Active Ingredient(s): ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
OTC/RX Status: RX
Indication(s):For the treatment of moderate to severe vasomotor symptoms associated with menopause and for prevention of osteoporosis

Original Application #: 020931
Approval Date: 01-OCT-99
Trade Name:TIKOSYN
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: CAPSULE
Applicant: PFIZER CHEMICAL CORP
Active Ingredient(s): DOFETILIDE
OTC/RX Status: RX
Indication(s): For the maintenance of normal sinus rhythym (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFI]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythym.

Original Application #: 020746
Approval Date: 01-OCT-99
Trade Name: RHINOCORT AQUA
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: AEROSOL, METERED
Applicant: ASTRA PHARMACEUTICALS LP
Active Ingredient(s): BUDESONIDE
OTC/RX Status: RX
Indication(s): For the management of nasal symptoms of seasonal or perennial allergic rhinitis in adults and children six years of age and older

Efficacy Supplemental New Drug Applications

Application #: 020381 Efficacy Supplement#: 006
Type: SE1 to Original New Drug Application
Approval Date: 28-OCT-99
Trade Name: NIASPAN
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: KOS PHARMACEUTICALS INC
Active Ingredient(s): NIACIN
OTC/RX Status: RX
Efficacy Claim: For use an an adjunct to diet for reduction of elevated TC, LDL-C, Apo B and TG levels and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Frederickson Types IIa and IIb) when the response to an appropriate diet has been inadequate.

Application #: 020154 Efficacy Supplement#: 029
Type: SE2 to Original New Drug Application
Approval Date: 28-OCT-99
Trade Name: VIDEX
Dosage Form: TABLET, CHEWABLE
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): DIDANOSINE
OTC/RX Status: RX
Efficacy Claim: Provides for a new strength as well as allowing a change in dosing interval to once-daily administration, when used in combination therapy for the treatment of HIV-1 infection.

Application #: 020155 Efficacy Supplement#: 021
Type: SE2 to Original New Drug Application
Approval Date: 28-OCT-99
Trade Name: VIDEX
Dosage Form: POWDER, FOR ORAL SOLUTION
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): DIDANOSINE
OTC/RX Status: RX
Efficacy Claim: Provides for a new strength as well as allowing a change in dosing interval to once-daily administration, when used in combination therapy for the treatment of HIV-1 infection.

Application #: 020156 Efficacy Supplement#: 022
Type: SE2 to Original New Drug Application
Approval Date: 28-OCT-99
Trade Name: VIDEX
Dosage Form: POWDER, FOR RECONSTITUTION
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): DIDANOSINE
OTC/RX Status: RX
Efficacy Claim:Provides for a new strength as well as allowing a change in dosing interval to once-daily administration, when used in combination therapy for the treatment of HIV-1 infection

Application #: 020262 Efficacy Supplement#: 033
Type: SE1 to Original New Drug Application
Approval Date: 25-OCT-99
Trade Name: TAXOL
Dosage Form: INJECTABLE
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): PACLITAXEL
OTC/RX Status: RX
Efficacy Claim: For the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy

Application #: 020630 Efficacy Supplement #: 001
Type: SE5 to Original New Drug Application
Approval Date: 15-OCT-99
Trade Name: ULTIVA
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): REMIFENTANIL HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim: For use as an analgesic agent during the maintenance of general anesthesia in pediatric patients for inpatient and outpatient surgery

Application #: 020802 Efficacy Supplement #: 002
Type: SE1 to Original New Drug Application
Approval Date: 07-OCT-99
Trade Name: EXCEDRIN (MIGRAINE)
Dosage Form: TABLET
Applicant: BRISTOL MYERS PRODUCTS INC
Active Ingredient(s): ACETAMINOPHEN; ASPIRIN; CAFFEINE
OTC/RX Status: OTC
Efficacy Claim: For the treatment of migraine

Application #: 020844 Efficacy Supplement#: 004
Type: SE1 to Original New Drug Application
Approval Date: 01-OCT-99
Trade Name: TOPAMAX SPRINKLE
Dosage Form: CAPSULE
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): TOPIRAMATE
OTC/RX Status: RX
Efficacy Claim: Provides for the use of Topamax Sprinkle Capsules as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures

Application #: 020719 Efficacy Supplement#: 012
Type: SE1 to Original New Drug Application
Approval Date: 01-OCT-99
Trade Name: PRELAY
Dosage Form: TABLET
Applicant: SANKYO USA CORP
Active Ingredient(s): TROGLITAZONE
OTC/RX Status: RX
Efficacy Claim: For combination therapy with metformin and sulfonylurea in patients with type 2 diabetes

Application #: 020505 Efficacy Supplement#: 003
Type: SE1 to Original New Drug Application
Approval Date: 01-OCT-99
Trade Name: TOPAMAX
Dosage Form: TABLET
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): TOPIRAMATE
OTC/RX Status: RX
Efficacy Claim:Provides for the use of Topamax Tablets as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures

Approvable Original New Drug Applications

Original Application #: 021016
Approvable Date: 27-OCT-99
Trade Name: REPLAX
Dosage Form: TABLET, FILM COATED
Applicant: PFIZER INC
Active Ingredient(s): ELETRIPTAN HYDROBROMIDE
OTC/RX Status: RX

Original Abbreviated New Drug Applications

Original Abbreviated Antibiotic Application#065004
Approval Date: 29-OCT-99
Trade Name: CYCLOSPORINE
Dosage Form: INJECTABLE
Applicant: BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
Active Ingredient(s): CYCLOSPORINE
OTC/RX Status: RX

Original Abbreviated Antibiotic Application#064217
Approval Date: 29-OCT-99
Trade Name: RIFAMPIN
Dosage Form: INJECTABLE
Applicant: BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
Active Ingredient(s): RIFAMPIN
OTC/RX Status: RX

Original Abbreviated Application # 075221
Approval Date: 28-OCT-99
Trade Name: ALFENTANIL
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): ALFENTANIL HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Antibiotic Application# 064134
Approval Date: 27-OCT-99
Trade Name: TOBRAMYCIN & DEXAMETHASONE
Dosage Form: SUSPENSION
Applicant: BAUSCH AND LOMB PHARMACEUTICALS INC
Active Ingredient(s): TOBRAMYCIN; DEXAMETHASONE
OTC/RX Status: RX

Original Abbreviated Application # 075346
Approval Date: 25-OCT-99
Trade Name: CROMOLYN SODIUM
Dosage Form: SOLUTION
Applicant: MORTON GROVE PHARMACEUTICALS INC
Active Ingredient(s): CROMOLYN SODIUM
OTC/RX Status: RX

Original Abbreviated Application # 075230
Approval Date: 25-OCT-99
Trade Name: KETOROLAC TROMETHAMINE
Dosage Form: INJECTABLE
Applicant: BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
Active Ingredient(s): KETOROLAC TROMETHAMINE
OTC/RX Status: RX

Original Abbreviated Application # 075541
Approval Date: 22-OCT-99
Trade Name: BETAXOLOL HCL
Dosage Form: TABLET, FILM COATED
Applicant: AMIDE PHARMACEUTICAL INC
Active Ingredient(s): BETAXOLOL HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075164
Approval Date: 21-OCT-99
Trade Name: VECURONIUM BROMIDE
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): VECURONIUM BROMIDE
OTC/RX Status: RX

Original Abbreviated Application # 075225
Approval Date: 20-OCT-99
Trade Name: ISOFLURANE
Dosage Form: LIQUID
Applicant: HALOCARBON PRODUCTS CORP
Active Ingredient(s): ISOFLURANE
OTC/RX Status: RX

Original Abbreviated Application # 040306
Approval Date: 20-OCT-99
Trade Name: METADATE ER
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: MEDEVA PHARMACEUTICALS INC
Active Ingredient(s): METHYLPHENIDATE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 040318
Approval Date: 05-OCT-99
Trade Name: MEPERIDINE HCL
Dosage Form: TABLET
Applicant: DURAMED PHARMACEUTICALS INC
Active Ingredient(s): MEPERIDINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075166
Approval Date: 07-OCT-99
Trade Name: ISOSORBIDE MONONITRATE
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: BRIGHTSTONE PHARMA INC
Active Ingredient(s): ISOSORBIDE MONONITRATE
OTC/RX Status: RX

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

Original Abbreviated Application #: 075458
Tentative Approval Date: 29-OCT-99
Trade Name: ENALAPRILAT
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): ENALAPRILAT
OTC/RX Status: RX

Original Abbreviated Application #: 075456
Tentative Approval Date: 29-OCT-99
Trade Name: ENALAPRILAT
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): ENALAPRILAT
OTC/RX Status: RX

Original Abbreviated Application #: 075574
Tentative Approval Date: 28-OCT-99
Trade Name: DOXAZOSIN MESYLATE
Dosage Form: TABLET
Applicant: PUREPAC PHARMACEUTICAL CO DIV PUREPAC INC
Active Ingredient(s): DOXAZOSIN MESYLATE
OTC/RX Status: RX

Original Abbreviated Application #: 075293
Tentative Approval Date: 27-OCT-99
Trade Name: MIDAZOLAM
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): MIDAZOLAM HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application #: 074994
Tentative Approval Date: 25-OCT-99
Trade Name: TICLOPIDINE HYDROCHLORIDE
Dosage Form: TABLET
Applicant: NOVOPHARM NC INC
Active Ingredient(s): TICLOPIDINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application #: 075116
Tentative Approval Date: 22-OCT-99
Trade Name: DILTIAZEM HYDROCHLORIDE
Dosage Form: CAPSULE, EXTENDED RELEASE
Applicant: BIOVAIL LABORATORIES INC
Active Ingredient(s): DILTIAZEM HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application #: 075237
Tentative Approval Date: 21-OCT-99
Trade Name: SOTALOL HCL
Dosage Form: TABLET
Applicant: GENPHARM INC
Active Ingredient(s): SOTALOL HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application #: 075245
Tentative Approval Date: 18-OCT-99
Trade Name: FLUOXETINE HCL
Dosage Form: CAPSULE
Applicant: ZENITH GOLDLINE PHARMACEUTICALS
Active Ingredient(s): FLUOXETINE HYDROCHLORIDE
OTC/RX Status: RX

Labeling Supplements to Original New Drug Applications

Application #: 011719 Labeling Supplement#: 099
To Original New Drug Application
Approval Date: 29-OCT-99
Trade Name: METHOTREXATE SODIUM
Dosage Form: INJECTABLE
Applicant: LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
Active Ingredient(s): METHOTREXATE SODIUM
OTC/RX Status: RX

Application #: 008085 Labeling Supplement#: 048
To Original New Drug Application
Approval Date: 29-OCT-99
Trade Name: METHOTREXATE SODIUM
Dosage Form: TABLET
Applicant: LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
Active Ingredient(s):METHOTREXATE SODIUM
OTC/RX Status: RX

Application #: 021052 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 28-OCT-99
Trade Name: VIOXX
Dosage Form: SUSPENSION
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): ROFECOXIB
OTC/RX Status: RX

Application #: 021042 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 28-OCT-99
Trade Name: VIOXX
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): ROFECOXIB
OTC/RX Status: RX

Application #: 020051 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 28-OCT-99
Trade Name: GLYNASE PRESTAB
Dosage Form: TABLET
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): GLYBURIDE
OTC/RX Status: RX

Application #: 017498 Labeling Supplement#: 021
To Original New Drug Application
Approval Date: 28-OCT-99
Trade Name: MICRONASE
Dosage Form: TABLET
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): GLYBURIDE
OTC/RX Status: RX

Application #: 015500 Labeling Supplement#: 050
To Original New Drug Application
Approval Date: 28-OCT-99
Trade Name: TOLINASE
Dosage Form: TABLET
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): TOLAZAMIDE
OTC/RX Status: RX

Application #: 20945 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 26-OCT-99
Trade Name: NORVIR
Dosage Form: CAPSULE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): RITONAVIR
OTC/RX Status: RX

Application #: 020659 Labeling Supplement#: 022
To Original New Drug Application
Approval Date: 26-OCT-99
Trade Name: NORVIR
Dosage Form: SOLUTION
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): RITONAVIR
OTC/RX Status: RX

Application #: 020933 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 25-OCT-99
Trade Name: VIRAMUNE
Dosage Form: SUSPENSION
Applicant: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Active Ingredient(s): NEVIRAPINE
OTC/RX Status: RX

Application #:020636Labeling Supplement#:011
To Original New Drug Application
Approval Date: 25-OCT-99
Trade Name: VIRAMUNE
Dosage Form: TABLET
Applicant: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Active Ingredient(s): NEVIRAPINE
OTC/RX Status: RX

Application #: 018703 Labeling Supplement#: 058
To Original New Drug Application
Approval Date: 22-OCT-99
Trade Name: ZANTAC 150
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 018703 Labeling Supplement#: 057
To Original New Drug Application
Approval Date: 22-OCT-99
Trade Name: ZANTAC 150
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: RX

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Application #: 020251 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 22-OCT-99
Trade Name: ZANTAC 150
Dosage Form: TABLET, EFFERVESCENT
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020251 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 22-OCT-99
Trade Name: ZANTAC 150
Dosage Form: TABLET, EFFERVESCENT
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020095 Labeling Supplement#: 010
To Original New Drug Application
Approval Date: 22-OCT-99
Trade Name: ZANTAC 150
Dosage Form: CAPSULE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020095 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 22-OCT-99
Trade Name: ZANTAC 150
Dosage Form: CAPSULE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 019675 Labeling Supplement#: 022
To Original New Drug Application
Approval Date: 22-OCT-99
Trade Name: ZANTAC
Dosage Form: SYRUP
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 019675 Labeling Supplement#: 021
To Original New Drug Application
Approval Date: 22-OCT-99
Trade Name: ZANTAC
Dosage Form: SYRUP
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 019090 Labeling Supplement#: 040
To Original New Drug Application
Approval Date: 22-OCT-99
Trade Name: ZANTAC
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 019090 Labeling Supplement#: 039
To Original New Drug Application
Approval Date: 22-OCT-99
Trade Name: ZANTAC
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 019593 Labeling Supplement#: 040
To Original New Drug Application
Approval Date: 22-OCT-99
Trade Name: ZANTAC
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 019593 Labeling Supplement#: 039
To Original New Drug Application
Approval Date: 22-OCT-99
Trade Name: ZANTAC
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020130 Labeling Supplement#: 005
To Original New Drug Application
Approval Date: 25-OCT-99
Trade Name: ESTROSTEP
Dosage Form: TABLET
Applicant: PARKE DAVIS
Active Ingredient(s): NORETHINDRONE ACETATE; ETHINYL ESTRADIOL
OTC/RX Status: RX

Application #: 020945 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 21-OCT-99
Trade Name: NORVIR
Dosage Form: CAPSULE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): RITONAVIR
OTC/RX Status: RX

Application #: 020659 Labeling Supplement#: 021
To Original New Drug Application
Approval Date: 21-OCT-99
Trade Name: NORVIR
Dosage Form: SOLUTION
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): RITONAVIR
OTC/RX Status: RX

Application #: 050443 Labeling Supplement#: 029
To Original New Drug Application
Approval Date: 20-OCT-99
Trade Name: BLENOXANE
Dosage Form: INJECTABLE
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): BLEOMYCIN SULFATE
OTC/RX Status: RX

Application #: 020677 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 19-OCT-99
Trade Name: ZAGAM
Dosage Form: TABLET
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): SPARFLOXACIN
OTC/RX Status: RX

Application #: 020677 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 19-OCT-99
Trade Name: ZAGAM
Dosage Form: TABLET
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): SPARFLOXACIN
OTC/RX Status: RX

Application #: 016093 Labeling Supplement#: 038
To Original New Drug Application
Approval Date: 19-OCT-99
Trade Name: EDECRIN
Dosage Form: INJECTABLE
Applicant: MERCK AND CO INC
Active Ingredient(s): ETHACRYNATE SODIUM
OTC/RX Status: RX

Application #: 016092 Labeling Supplement#: 037
To Original New Drug Application
Approval Date: 19-OCT-99
Trade Name: EDECRIN
Dosage Form: TABLET
Applicant: MERCK AND CO INC
Active Ingredient(s): ETHACRYNIC ACID
OTC/RX Status: RX

Application #: 020597 Labeling Supplement #: 012
To Original New Drug Application
Approval Date: 08-OCT-99
Trade Name: XALATAN
Dosage Form: SOLUTION, DROPS
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): LATANOPROST
OTC/RX Status: RX

Application #: 019757 Labeling Supplement #: 009
To Original New Drug Application
Approval Date: 08-OCT-99
Trade Name: CHIBROXIN
Dosage Form: SOLUTION
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): NORFLOXACIN
OTC/RX Status: RX

Application #: 018972 Labeling Supplement#: 020
To Original New Drug Application
Approval Date: 08-OCT-99
Trade Name: CORDARONE
Dosage Form: TABLET
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): AMIODARONE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 018972 Labeling Supplement#: 019
To Original New Drug Application
Approval Date: 08-OCT-99
Trade Name: CORDARONE
Dosage Form: TABLET
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): AMIODARONE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 019385 Labeling Supplement#: 026
To Original New Drug Application
Approval Date: 06-OCT-99
Trade Name: PERMAX
Dosage Form: TABLET
Applicant: ELI LILLY AND CO
Active Ingredient(s): PERGOLIDE MESYLATE
OTC/RX Status: RX

Application #: 019385 Labeling Supplement#: 020
To Original New Drug Application
Approval Date: 06-OCT-99
Trade Name: PERMAX
Dosage Form: TABLET
Applicant: ELI LILLY AND CO
Active Ingredient(s): PERGOLIDE MESYLATE
OTC/RX Status: RX

Application #: 019385 Labeling Supplement#: 019
To Original New Drug Application
Approval Date: 06-OCT-99
Trade Name: PERMAX
Dosage Form: TABLET
Applicant: ELI LILLY AND CO
Active Ingredient(s): PERGOLIDE MESYLATE
OTC/RX Status: RX

Application #: 019385 Labeling Supplement#: 017
To Original New Drug Application
Approval Date: 06-OCT-99
Trade Name: PERMAX
Dosage Form: TABLET
Applicant: ELI LILLY AND CO
Active Ingredient(s): PERGOLIDE MESYLATE
OTC/RX Status: RX

Application #: 019385 Labeling Supplement#: 016
To Original New Drug Application
Approval Date: 06-OCT-99
Trade Name: PERMAX
Dosage Form: TABLET
Applicant: ELI LILLY AND CO
Active Ingredient(s): PERGOLIDE MESYLATE
OTC/RX Status: RX

Application #: 019385 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 06-OCT-99
Trade Name: PERMAX
Dosage Form: TABLET
Applicant: ELI LILLY AND CO
Active Ingredient(s): PERGOLIDE MESYLATE
OTC/RX Status: RX

Application #: 019385 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 06-OCT-99
Trade Name: PERMAX
Dosage Form: TABLET
Applicant: ELI LILLY AND CO
Active Ingredient(s): PERGOLIDE MESYLATE
OTC/RX Status: RX

Application #: 020164 Labeling Supplement#: 031
To Original New Drug Application
Approval Date: 05-OCT-99
Trade Name: LOVENOX
Dosage Form: INJECTABLE
Applicant: RHONE POULENC RORER PHARMACEUTICALS INC
Active Ingredient(s): ENOXAPARIN SODIUM
OTC/RX Status: RX

Application #: 019998 Labeling Supplement#: 011
To Original New Drug Application
Approval Date: 05-OCT-99
Trade Name: CHEMET
Dosage Form: CAPSULE
Applicant: SANOFI SYNTHELABO INC
Active Ingredient(s): SUCCIMER
OTC/RX Status: RX