Drug Approvals for April 1998

Definitions and Notes

April 1998

Original New Drug Applications

Original Application #: 020896
Approval Date: 30-APR-98
Trade Name: XELODA
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: TABLET
Applicant: HOFFMANN LA ROCHE INC
Active Ingredient(s): CAPECITABINE
OTC/RX Status: RX
Indication(s): Treatment of patients with metastatic breast cancer resistant to both paclitaxel and an anthracycline-containing chemotherapy regimen or resistant to paclitaxel and for whom further anthracycline therapy may be contraindicated, e.g., patients who have received cumulative doses of 400mg/m2 of doxorubicin or doxorubicin equivalents. Resistance is defined as progressive disease while on treatment, with or without an initial response, or relapse within 6 months of an anthracycline-containing adjuvant regimen.

Original Application #: 020846
Approval Date: 29-APR-98
Trade Name: LAMISIL
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: GEL
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): TERBINAFINE
OTC/RX Status: RX
Indication(s): Topical treatment of the following dermatologic infections: tinea (pityriasis) versicolor due to Malassezia furfur (formerly Pityrosporum ovale), tinea pedis (athlete’s foot) or tinea corporis (ringworm), due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum

Original Application #: 020713
Approval Date: 22-APR-98
Trade Name: MIRCETTE
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: ORGANON PHARMACEUTICALS
Active Ingredient(s): DESOGESTREL; ETHINYL ESTRADIOL
OTC/RX Status: RX
Indication(s): For the prevention of pregnancy

Original Application #: 020819
Approval Date: 17-APR-98
Trade Name: ZEMPLAR
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): PARICALCITOL
OTC/RX Status: RX
Indication(s): For the prevention and treatment of secondary hyperparathroidism encountered with chronic renal failure

Original Application #: 020816
Approval Date: 01-APR-98
Trade Name: AZOPT
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: SUSPENSION/DROPS
Applicant: ALCON LABORATORIES INC
Active Ingredient(s): BRINZOLAMIDE
OTC/RX Status: RX
Indication(s): Treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma

Efficacy Supplemental New Drug Applications

Application #: 020262 Efficacy Supplement#: 026
Type: SE1 to Original New Drug Application
Approval Date: 09-APR-98
Trade Name: TAXOL
Dosage Form: INJECTABLE
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): PACLITAXEL
OTC/RX Status: RX
Efficacy Claim: First-line therapy for the treatment of advanced carcinoma of the ovary in combination with cisplatin OTC/RX Status: RX

Application #: 050587 Efficacy Supplement#: 048
Type: SE5 to Original New Drug Application
Approval Date: 08-APR-98
Trade Name: PRIMAXIN
Dosage Form: INJECTABLE
Applicant: MERCK SHARP AND DOHME DIV MERCK AND CO INC
Active Ingredient(s): CILASTATIN SODIUM; IMIPENEM
OTC/RX Status: RX
Efficacy Claim: Treatment of serious infections caused by susceptible strains of designated microorganisms in pediatric patients

Application #: 019858 Efficacy Supplement#: 012
Type: SE5 to Original New Drug Application
Approval Date: 03-APR-98
Trade Name: CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Dosage Form: INJECTABLE
Applicant: BAYER CORP
Active Ingredient(s): CIPROFLOXACIN
OTC/RX Status: RX
Efficacy Claim: Provides for the addition of information pertaining to the use in Cystic Fibrosis patients to the Pediatric Use subsection of the labeling

Application #: 019857 Efficacy Supplement#: 014
Type: SE5 to Original New Drug Application
Approval Date: 03-APR-98
Trade Name: CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER
Dosage Form: INJECTABLE
Applicant: BAYER CORP
Active Ingredient(s): CIPROFLOXACIN
OTC/RX Status: RX
Efficacy Claim: Provides for the addition of information pertaining to the use in Cystic Fibrosis patients to the Pediatric Use subsection of the labeling

Application #: 019847 Efficacy Supplement#: 013
Type: SE5 to Original New Drug Application
Approval Date: 03-APR-98
Trade Name: CIPRO
Dosage Form: INJECTABLE
Applicant: BAYER CORP
Active Ingredient(s): CIPROFLOXACIN
OTC/RX Status: RX
Efficacy Claim: Provides for the addition of information pertaining to the use in Cystic Fibrosis patients to the Pediatric Use subsection of the labeling

Application #: 019537 Efficacy Supplement#: 027
Type: SE5 to Original New Drug Application
Approval Date: 03-APR-98
Trade Name: CIPRO
Dosage Form: TABLET
Applicant: BAYER CORP
Active Ingredient(s): CIPROFLOXACIN HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim: Provides for the addition of information pertaining to the use in Cystic Fibrosis patients to the Pediatric Use subsection of the labeling

Application #: 020555 Efficacy Supplement#: 004
Type: SE2 to Original New Drug Application
Approval Date: 01-APR-98
Trade Name: AXID AR
Dosage Form: TABLET
Applicant: WHITEHALL ROBINS HEALTHCARE
Active Ingredient(s): NIZATIDINE
OTC/RX Status: OTC
Efficacy Claim: Provides for a revision to the Directions section of the labeling and labels to change the time to take the drug prior to a meal to prevent meal-induced heartburn symptoms from “...one-half hour to one hour before eating...” to “...right before eating or up to 60 minutes before consuming...”.

Application #: 020555 Efficacy Supplement#: 003
Type: SE1 to Original New Drug Application
Approval Date: 01-APR-98
Trade Name: AXID AR
Dosage Form: TABLET
Applicant: WHITEHALL ROBINS HEALTHCARE
Active Ingredient(s): NIZATIDINE
OTC/RX Status: OTC
Efficacy Claim: Provides for treatment of episodic heartburn, acid indigestion and sour stomach

Application #: 020393 Efficacy Supplement#: 001
Type: SE1 to Original New Drug Application
Approval Date: 01-APR-98
Trade Name: ATROVENT
Dosage Form: SPRAY
Applicant: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Active Ingredient(s): IPRATROPIUM BROMIDE
OTC/RX Status: RX
Efficacy Claim: For use in the symptomatic relief of rhinorrhea associated with allergic and nonallergic perennial rhinitis in children age 6 to 11 years

Approvable Original New Drug Applications

Original Application #: 020718
Approvable Date: 01-APR-98
Trade Name: INTEGRILIN
Dosage Form: INJECTABLE
Applicant: COR THERAPEUTICS INC
Active Ingredient(s): EPTIFIBATIDE
OTC/RX Status: RX

Original Abbreviated New Drug Applications

Original Abbreviated Application # 075135
Approval Date: 30-APR-98
Trade Name: PACERONE
Dosage Form: TABLET
Applicant: UPSHER SMITH LABORATORIES INC
Active Ingredient(s): AMIODARONE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075078
Approval Date: 30-APR-98
Trade Name: ETODOLAC
Dosage Form: CAPSULE
Applicant: TARO PHARMACEUTICAL INDUSTRIES LTD
Active Ingredient(s): ETODOLAC
OTC/RX Status: RX

Original Abbreviated Application # 075015
Approval Date: 30-APR-98
Trade Name: ACYCLOVIR SODIUM
Dosage Form: INJECTABLE
Applicant: AESGEN INC
Active Ingredient(s): ACYCLOVIR SODIUM
OTC/RX Status: RX

Original Abbreviated Application # 074947
Approval Date: 30-APR-98
Trade Name: CLOMIPRAMINE HYDROCHLORIDE
Dosage Form: CAPSULE
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): CLOMIPRAMINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 074912
Approval Date: 30-APR-98
Trade Name: SELEGILINE HYDROCHLORIDE
Dosage Form: TABLET
Applicant: STASON INDUSTRIAL CORP
Active Ingredient(s): SELEGILINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Antibiotic Application#064144
Approval Date: 30-APR-98
Trade Name: MITOMYCIN
Dosage Form: INJECTABLE
Applicant: SUPERGEN INC
Active Ingredient(s): MITOMYCIN
OTC/RX Status: RX

Original Abbreviated Application # 040180
Approval Date: 30-APR-98
Trade Name: METHADONE HYDROCHLORIDE
Dosage Form: CONCENTRATE
Applicant: ROXANE LABORATORIES INC
Active Ingredient(s): METHADONE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 074924
Approval Date: 29-APR-98
Trade Name: MINOXIDIL (FOR MEN AND WOMEN)
Dosage Form: SOLUTION
Applicant: NU PHARM INC
Active Ingredient(s): MINOXIDIL
OTC/RX Status: OTC

Original Abbreviated Application # 074706
Approval Date: 29-APR-98
Trade Name: CROMOLYN SODIUM
Dosage Form: SOLUTION/DROPS
Applicant: ADVANCED REMEDIES INC
Active Ingredient(s): CROMOLYN SODIUM
OTC/RX Status: RX

Original Abbreviated Application # 075069
Approval Date: 16-APR-98
Trade Name: ETODOLAC
Dosage Form: TABLET
Applicant: CHELSEA LABORATORIES INC
Active Ingredient(s): ETODOLAC
OTC/RX Status: RX

Original Abbreviated Application # 074966
Approval Date: 16-APR-98
Trade Name: FLUPHENAZINE DECANOATE
Dosage Form: INJECTABLE
Applicant: KING PHARMACEUTICALS INC
Active Ingredient(s): FLUPHENAZINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Antibiotic Application# 064192
Approval Date: 16-APR-98
Trade Name: CEFUROXIME
Dosage Form: INJECTABLE
Applicant: ASTRA USA INC
Active Ingredient(s): CEFUROXIME SODIUM
OTC/RX Status: RX

Original Abbreviated Antibiotic Application# 064191
Approval Date: 16-APR-98
Trade Name: CEFUROXIME
Dosage Form: INJECTABLE
Applicant: ASTRA USA INC
Active Ingredient(s): CEFUROXIME SODIUM
OTC/RX Status: RX

Original Abbreviated Application # 075101
Approval Date: 15-APR-98
Trade Name: ACYCLOVIR
Dosage Form: CAPSULE
Applicant: CHELSEA LABORATORIES INC
Active Ingredient(s): ACYCLOVIR
OTC/RX Status: RX

Original Abbreviated Application # 074941
Approval Date: 15-APR-98
Trade Name: DILTIAZEM HCL
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): DILTIAZEM HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 074977
Approval Date: 13-APR-98
Trade Name: ACYCLOVIR
Dosage Form: CAPSULE
Applicant: GENPHARM INC
Active Ingredient(s): ACYCLOVIR
OTC/RX Status: RX

Original Abbreviated Application # 074976
Approval Date: 13-APR-98
Trade Name: ACYCLOVIR
Dosage Form: TABLET
Applicant: GENPHARM INC
Active Ingredient(s): ACYCLOVIR
OTC/RX Status: RX

Original Abbreviated Application # 074939
Approval Date: 13-APR-98
Trade Name: DIPYRIDAMOLE
Dosage Form: INJECTABLE
Applicant: BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
Active Ingredient(s): DIPYRIDAMOLE
OTC/RX Status: RX

Original Abbreviated Application # 074865
Approval Date: 13-APR-98
Trade Name: MEXILETINE HCL
Dosage Form: CAPSULE
Applicant: DANBURY PHARMACAL INC
Active Ingredient(s): MEXILETINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Antibiotic Application# 064211
Approval Date: 13-APR-98
Trade Name: TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE
Dosage Form: SOLUTION/DROPS
Applicant: ALCON LABORATORIES INC
Active Ingredient(s): POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE
OTC/RX Status: RX

Original Abbreviated Application # 075086
Approval Date: 09-APR-98
Trade Name: DILTIAZEM HCL
Dosage Form: INJECTABLE
Applicant: TAYLOR PHARMACAL CO
Active Ingredient(s): DILTIAZEM HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 073440
Approval Date: 01-APR-98
Trade Name: DESOXIMETASONE
Dosage Form: OINTMENT
Applicant: ALTANA INC
Active Ingredient(s): DESOXIMETASONE
OTC/RX Status: RX

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

Original Abbreviated Application #: 075195
Tentative Approval Date: 30-APR-98
Trade Name: BUSPIRONE HYDROCHLORIDE
Dosage Form: TABLET
Applicant: CHELSEA LABORATORIES INC
Active Ingredient(s): BUSPIRONE HYDROCHLORIDE
OTC/RX Status: RX

Labeling Supplements to Original New Drug Applications

Application #: 020830 Labeling Supplement#: 003
To Original New Drug Application
Approval Date: 30-APR-98
Trade Name: SINGULAIR
Dosage Form: TABLET, CHEWABLE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): MONTELUKAST SODIUM
OTC/RX Status: RX

Application #: 020829 Labeling Supplement#: 003
To Original New Drug Application
Approval Date: 30-APR-98
Trade Name: SINGULAR
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): MONTELUKAST SODIUM
OTC/RX Status: RX

Application #: 018705 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 24-APR-98
Trade Name: NITROLINGUAL
Dosage Form: SPRAY
Applicant: G POHL BOSKAMP GMBH AND CO
Active Ingredient(s): NITROGLYCERIN
OTC/RX Status: RX

Application #: 020156 Labeling Supplement#: 018
To Original New Drug Application
Approval Date: 23-APR-98
Trade Name: VIDEX
Dosage Form: POWDER, FOR RECONSTITUTION
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): DIDANOSINE
OTC/RX Status: RX

Application #: 020155 Labeling Supplement#: 018
To Original New Drug Application
Approval Date: 23-APR-98
Trade Name: VIDEX
Dosage Form: POWDER, FOR RECONSTITUTION
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): DIDANOSINE
OTC/RX Status: RX

Application #: 020154 Labeling Supplement#: 023
To Original New Drug Application
Approval Date: 23-APR-98
Trade Name: VIDEX
Dosage Form: TABLET, CHEWABLE
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): DIDANOSINE
OTC/RX Status: RX

Application #: 050661 Labeling Supplement#: 006
To Original New Drug Application
Approval Date: 22-APR-98
Trade Name: IDAMYCIN
Dosage Form: INJECTABLE
Applicant: PHARMACIA AND UPJOHN
Active Ingredient(s): IDARUBICIN HYDROCHLORIDE
OTC/RX Status: RX

Application #: 011120 Labeling Supplement#: 081
To Original New Drug Application
Approval Date: 22-APR-98
Trade Name: THORAZINE
Dosage Form: CAPSULE, EXTENDED RELEASE
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): CHLORPROMAZINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 009149 Labeling Supplement#: 165
To Original New Drug Application
Approval Date: 22-APR-98
Trade Name: THORAZINE
Dosage Form: CONCENTRATE; INJECTABLE; SUPPOSITORY; SYRUP; TABLET
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): CHLORPROMAZINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 018986 Labeling Supplement#: 010
To Original New Drug Application
Approval Date: 21-APR-98
Trade Name: PRALIDOXIME CHLORIDE
Dosage Form: INJECTABLE
Applicant: MERIDIAN MEDICAL TECHNOLOGIES INC
Active Ingredient(s): PRALIDOXIME CHLORIDE
OTC/RX Status: RX

Application #: 017106 Labeling Supplement#: 014
To Original New Drug Application
Approval Date: 21-APR-98
Trade Name: ATROPEN
Dosage Form: INJECTABLE
Applicant: MERIDIAN MEDICAL TECHNOLOGIES INC
Active Ingredient(s): ATROPINE
OTC/RX Status: RX

Application #: 020142 Labeling Supplement#: 005
To Original New Drug Application
Approval Date: 20-APR-98
Trade Name: CATAFLAM
Dosage Form: TABLET
Applicant: CIBA VISION CORP A NOVARTIS CO
Active Ingredient(s): DICLOFENAC POTASSIUM
OTC/RX Status: RX

Application #: 019201 Labeling Supplement#: 022
To Original New Drug Application
Approval Date: 20-APR-98
Trade Name: VOLTAREN
Dosage Form: TABLET, DELAYED RELEASE
Applicant: CIBA VISION CORP A NOVARTIS CO
Active Ingredient(s): DICLOFENAC SODIUM
OTC/RX Status: RX

Application #: 018202 Labeling Supplement#: 015
To Original New Drug Application
Approval Date: 15-APR-98
Trade Name: CYTADREN
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): AMINOGLUTETHIMIDE
OTC/RX Status: RX

Application #: 020708 Labeling Supplement#: 003
To Original New Drug Application
Approval Date: 09-APR-98
Trade Name: LUPRON DEPOT-3
Dosage Form: INJECTALBE
Applicant: TAP HOLDINGS INC
Active Ingredient(s): LEUPROLIDE ACETATE
OTC/RX Status: RX

Application #: 020011 Labeling Supplement#: 014
To Original New Drug Application
Approval Date: 09-APR-98
Trade Name: LUPRON DEPOT
Dosage Form: INJECTABLE
Applicant: TAP HOLDINGS INC
Active Ingredient(s): LEUPROLIDE ACETATE
OTC/RX Status: RX

Application #: 019726 Labeling Supplement#: 022
To Original New Drug Application
Approval Date: 09-APR-98
Trade Name: ZOLADEX
Dosage Form: IMPLANT
Applicant: ZENECA PHARMACEUTICALS DIV ZENECA INC
Active Ingredient(s): GOSERELIN ACETATE
OTC/RX Status: RX

Application #: 020312 Labeling Supplement#: 010
To Original New Drug Application
Approval Date: 08-APR-98
Trade Name: UNIVASC
Dosage Form: TABLET
Applicant: SCHWARZ PHARMA INC
Active Ingredient(s): MOEXIPRIL HYDROCHLORIDE
OTC/RX Status: RX

Application #: 008578 Labeling Supplement#: 014
To Original New Drug Application
Approval Date: 08-APR-98
Trade Name: DARAPRIM
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): PYRIMETHAMINE
OTC/RX Status: RX

Application #: 008578 Labeling Supplement#: 010
To Original New Drug Application
Approval Date: 08-APR-98
Trade Name: DARAPRIM
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): PYRIMETHAMINE
OTC/RX Status: RX

Application #: 009175 Labeling Supplement#: 022
To Original New Drug Application
Approval Date: 07-APR-98
Trade Name: FURADANTIN
Dosage Form: SUSPENSION
Applicant: DURA PHARMACEUTICALS INC
Active Ingredient(s): NITROFURANTOIN
OTC/RX Status: RX

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Application #: 020555 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 01-APR-98
Trade Name: AXID AR
Dosage Form: TABLET
Applicant: WHITEHALL ROBINS HEALTHCARE
Active Ingredient(s): NIZATIDINE
OTC/RX Status: OTC

Application #: 020535 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 31-MAR-98
Trade Name: DURACT
Dosage Form: CAPSULE
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): BROMFENAC SODIUM
OTC/RX Status: RX

Application #: 018826 Labeling Supplement#: 023
To Original New Drug Application
Approval Date: 08-APR-98
Trade Name: DOPAMINE HCL IN 5% DEXTROSE IN PLASTIC CONTAINER
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): DOPAMINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020491 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 03-APR-98
Trade Name: CORVERT
Dosage Form: INJECTABLE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): IBUTILIDE FUMARATE
OTC/RX Status: RX

Application #: 020387 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 03-APR-98
Trade Name: HYZAAR
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
OTC/RX Status: RX

Application #: 020386 Labeling Supplement#: 012
To Original New Drug Application
Approval Date: 03-APR-98
Trade Name: COZAAR
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): LOSARTAN POTASSIUM
OTC/RX Status: RX

Application #: 020588 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 02-APR-98
Trade Name: RISPERDAL
Dosage Form: SOLUTION
Applicant: JANSSEN RESEARCH FDN DIV JOHNSON AND JOHNSON
Active Ingredient(s): RISPERIDONE
OTC/RX Status: RX

Application #: 020272 Labeling Supplement#: 006
To Original New Drug Application
Approval Date: 02-APR-98
Trade Name: RISPERDAL
Dosage Form: TABLET
Applicant: JANSSEN RESEARCH FDN DIV JOHNSON AND JOHNSON
Active Ingredient(s): RISPERIDONE
OTC/RX Status: RX

Application #: 017962 Labeling Supplement#: 052
To Original New Drug Application
Approval Date: 02-APR-98
Trade Name: PARLODEL
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): BROMOCRIPTINE MESYLATE
OTC/RX Status: RX

Application #: 006536 Labeling Supplement#: 038
To Original New Drug Application
Approval Date: 02-APR-98
Trade Name: URECHOLINE
Dosage Form: INJECTABLE; TABLET
Applicant: MERCK SHARP AND DOHME DIV MERCK AND CO INC
Active Ingredient(s): BETHANECHOL CHLORIDE
OTC/RX Status: RX

Application #: 020186 Labeling Supplement #: 008
To Original New Drug Application
Approval Date: 01-APR-98
Trade Name: ZIAC
Dosage Form: TABLET
Applicant: LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
Active Ingredient(s): BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX