Drug Approvals for December 1998

Definitions and Notes

December 1998

Original New Drug Applications

Original Application #: 020998
Approval Date: 31-DEC-98
Trade Name: CELEBREX
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: CAPSULE
Applicant: GD SEARLE AND CO
Active Ingredient(s): CELECOXIB
OTC/RX Status: RX
Indication(s):For the signs and symptoms of osteoarthritis and rheumatoid arthritis

Original Application #: 020717
Approval Date: 24-DEC-98
Trade Name: PROVIGIL
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: CEPHALON, INC
Active Ingredient(s): MODAFINIL
OTC/RX Status: RX
Indication(s):For the treatment of narcolepsy

Original Application #: 050762
Approval Date: 18-DEC-98
Trade Name: TROVAN/ZITHROMAX COMPLIANCE PAK
Chemical Type: 4
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: PFIZER PHARMACEUTICALS INC
Active Ingredient(s): TROVAFLOXACIN MESYLATE, AZITHROMYCIN
OTC/RX Status: RX
Indication(s):For the treatment of two Sexually Transmitted Diseases (STDs)

Original Application #: 020944
Approval Date: 18-DEC-98
Trade Name: ADVIL
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: TABLET, CHEWABLE
Applicant: WHITEHALL ROBINS HEALTHCARE
Active Ingredient(s): IBUPROFEN
OTC/RX Status: OTC
Indication(s):For the temporary reduction of fever and relief of minor aches and pains due to common cold, flu, sore throat, headaches and toothaches

Original Application #: 020897
Approval Date: 16-DEC-98
Trade Name: DITROPAN
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: ALZA CORP
Active Ingredient(s): OXYBUTYNIN CHLORIDE
OTC/RX Status: RX
Indication(s):For the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency

Original Application #: 020843
Approval Date: 16-DEC-98
Trade Name: PROMETRIUM
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: CAPSULE
Applicant: SCHERING PLOUGH HEALTHCARE PRODUCTS INC
Active Ingredient(s): PROGESTERONE
OTC/RX Status: RX
Indication(s):For use in the prevention of endometrial hyperplasia in nonhysterectomized post-menopausal women who are receiving conjugated estrogens tablets

Original Application #: 021004
Approval Date: 08-DEC-98
Trade Name: EPIVIR-HBV
Chemical Type:
Therapeutic Potential: P
Dosage Form: SOLUTION
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): LAMIVUDINE
OTC/RX Status: RX
Indication(s): For the treatment of chronic hepatitis B associated with evidence of hepatitis B viral replication and active liver inflammation

Original Application #: 021003
Approval Date: 08-DEC-98
Trade Name: EPIVIR-HBV
Chemical Type:
Therapeutic Potential: P
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): LAMIVUDINE
OTC/RX Status: RX
Indication(s):For the treatment of chronic hepatitis B associated with evidence of hepatitis B viral replication and active liver inflammation

Efficacy Supplemental New Drug Applications

Application #: 020164 Efficacy Supplement#: 015
Type: SE1 to Original New Drug Application
Approval Date: 31-DEC-98
Trade Name: LOVENOX
Dosage Form: INJECTABLE
Applicant: RHONE POULENC RORER PHARMACEUTICALS INC
Active Ingredient(s): ENOXAPARIN SODIUM
OTC/RX Status: RX
Efficacy Claim:For the inpatient treatment of acute deep vein thrombosis with and without pulmonary embolism, when administered in conjunction with warfarin sodium; and for the outpatient treatment of acute deep vein thrombosis without pulmonary embolism when administered in conjunction with warfarin sodium

Application #: 018612 Efficacy Supplement#: 025
Type: SE4 to Original New Drug Application
Approval Date: 23-DEC-98
Trade Name: NICORETTE
Dosage Form: GUM, CHEWING
Applicant: SMITHKLINE BEECHAM
Active Ingredient(s): NICOTINE POLACRILEX GUM
OTC/RX Status: RX
Efficacy Claim: For the over-the-counter (OTC) marketing of mint flavored Nicorette 2mg and 4mg gum for use by adults only

Application #: 020066 Efficacy Supplement: 007
Type: SE4 to Original New Drug Application
Approval Date: 23-DEC-98
Trade Name: NICORETTE
Dosage Form: GUM, CHEWING
Applicant: SMITHKLINE BEECHAM
Active Ingredient(s): NICOTINE POLACRILEX GUM
OTC/RX Status: RX
Efficacy Claim: For the over-the-counter (OTC) marketing of mint flavored Nicorette 2mg and 4mg gum for use by adults only

Application #: 020451 Efficacy Supplement#: 003
Type: SE1 to Original New Drug Application
Approval Date: 22-DEC-98
Trade Name: PHOTOFRIN
Dosage Form: INJECTABLE
Applicant: QLT PHOTO THERAPEUTICS INC
Active Ingredient(s): PORFIMER SODIUM
OTC/RX Status: RX
Efficacy Claim:For use in photodynamic therapy (PDT) for reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial nonsmall cell lung cancer (NSCLC)

Application #: 020635 Efficacy Supplement#: 003
Type: SE1 to Original New Drug Application
Approval Date: 17-DEC-98
Trade Name: LEVAQUIN
Dosage Form: INJECTABLE
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP
Active Ingredient(s): LEVOFLOXACIN
OTC/RX Status: RX
Efficacy Claim:For the treatment of uncomplicated urinary tract infections (UTI)

Application #: 020634 Efficacy Supplement#: 004
Type: SE1 to Original New Drug Application
Approval Date: 17-DEC-98
Trade Name: LEVAQUIN
Dosage Form: TABLET
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP
Active Ingredient(s): LEVOFLOXACIN
OTC/RX Status: RX
Efficacy Claim:For the treatment of uncomplicated urinary tract infections (UTI)

Application #: 019157 Efficacy Supplement#: 015
Type: SE5 to Original New Drug Application
Approval Date: 17-DEC-98
Trade Name: PEDIAPRED
Dosage Form: SOLUTION
Applicant: MEDEVA PHARMACEUTICALS INC
Active Ingredient(s): PREDNISOLONE SODIUM PHOSPHATE
OTC/RX Status: RX
Efficacy Claim: For Pediatric Use

Application #: 020764 Efficacy Supplement#: 001
Type: SE1 to Original New Drug Application
Approval Date: 14-DEC-98
Trade Name: LAMICTAL CD
Dosage Form: TABLET, CHEWABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): LAMOTRIGINE
OTC/RX Status: RX
Efficacy Claim:For conversion to monotherapy in adults with partial seizures who are receiving treatment with a single enzyme-inducing anti-epileptic drug (EIAED)

Application #: 020241 Efficacy Supplement#: 003
Type: SE1 to Original New Drug Application
Approval Date: 14-DEC-98
Trade Name: LAMICTAL
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): LAMOTRIGINE
OTC/RX Status: RX
Efficacy Claim:For conversion to monotherapy in adults with partial seizures who are receiving treatment with a single enzyme-inducing anti-epileptic drug (EIAED)

Application #: 020121 Efficacy Supplement#: 009
Type: SE1 to Original New Drug Application
Approval Date: 11-DEC-98
Trade Name: FLONASE
Dosage Form: SPRAY, METERED
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): FLUTICASONE PROPIONATE
OTC/RX Status: RX
Efficacy Claim:For the treatment of nasal symptoms of perennial nonallergic rhinitis in adults and pediatric patients 4 years and older

Approvable Original New Drug Applications

Original Application #: 020796
Approvable Date: 31-DEC-98
Trade Name: COMTAN
Dosage Form: TABLET
Applicant: ORION CORP ORION PHARMA
Active Ingredient(s): ENTACAPONE
OTC/RX Status: RX

Original Application #: 021012
Approvable Date: 16-DEC-98
Trade Name:NEOTECT
Dosage Form: INJECTABLE
Applicant: DIATIDE INC
Active Ingredient(s): TECHNETIUM TC-99M DEPREOTIDE
OTC/RX Status: RX

Original Abbreviated New Drug Applications

Original Abbreviated Application # 075306
Approval Date: 31-DEC-98
Trade Name: ISOSORBIDE MONONITRATE
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: PUREPAC PHARMACEUTICAL CO DIV PUREPAC INC
Active Ingredient(s): ISOSORBIDE MONONITRATE
OTC/RX Status: RX

Original Abbreviated Application # 074315
Approval Date: 31-DEC-98
Trade Name: TERAZOSIN HCL
Dosage Form: TABLET
Applicant: GENEVA PHARMACEUTICALS INC
Active Ingredient(s): TERAZOSIN HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 040226
Approval Date: 31-DEC-98
Trade Name: PERPHENAZINE
Dosage Form: TABLET
Applicant: VINTAGE PHARMACEUTICALS INC
Active Ingredient(s): PERPHENAZINE
OTC/RX Status: RX

Original Abbreviated Application # 075206
Approval Date: 30-DEC-98
Trade Name: CYTARABINE
Dosage Form: INJECATABLE
Applicant: GENSIA INC
Active Ingredient(s): CYTARABINE
OTC/RX Status: RX

Original Abbreviated Application # 040199
Approval Date: 30-DEC-98
Trade Name: OXYCODONE AND ACETAMINOPHEN
Dosage Form: CAPSULE
Applicant: AMIDE PHARMACEUTICAL INC
Active Ingredient(s): ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 040009
Approval Date: 30-DEC-98
Trade Name: ISOSORBIDE DINITRATE
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: INWOOD LABORATORIES INC SUB FOREST LABORATORIES INC
Active Ingredient(s): ISOSORBIDE DINITRATE
OTC/RX Status: RX

Original Abbreviated Application # 074721
Approval Date: 29-DEC-98
Trade Name: DOXEPIN HCL
Dosage Form: SOLUTION
Applicant: SILARX PHARMACEUTICALS INC
Active Ingredient(s): DOXEPIN HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 040283
Approval Date: 29-DEC-98
Trade Name: CARISOPRODOL, ASPIRIN & CODEINE PHOSPHATE
Dosage Form: TABLET
Applicant: AMIDE PHARMACEUTICAL INC
Active Ingredient(s): CARISOPRODOL; ASPIRIN; CODEINE PHOSPHATE
OTC/RX Status: RX

Original Abbreviated Application # 040275
Approval Date: 29-DEC-98
Trade Name: ESTRADIOL
Dosage Form: TABLET
Applicant: ESI LEDERLE INC
Active Ingredient(s): ESTRADIOL
OTC/RX Status: RX

Original Abbreviated Application # 040298
Approval Date: 28-DEC-98
Trade Name: EXTENDED PHENYTOIN SODIUM
Dosage Form: CAPSULE
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): EXTENDED PHENYTOIN SODIUM
OTC/RX Status: RX

Original Abbreviated Application # 040254
Approval Date: 24-DEC-98
Trade Name: TRIHEXYPHENIDYL HYDROCHLORIDE
Dosage Form: TABLET
Applicant: VINTAGE PHARMACEUTICALS INC
Active Ingredient(s): TRIHEXYPHENIDYL HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075060
Approval Date: 24-DEC-98
Trade Name: AMANTADINE HYDROCHLORIDE
Dosage Form: SYRUP
Applicant: MORTON GROVE PHARMACEUTICALS
Active Ingredient(s): AMANTADINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075213
Approval Date: 24-DEC-98
Trade Name: TRETINOIN
Dosage Form: CREAM
Applicant: SPEAR PHARMACEUTICALS
Active Ingredient(s): TRETINOIN
OTC/RX Status: RX

Original Abbreviated Application # 075264
Approval Date: 24-DEC-98
Trade Name: TRETINOIN
Dosage Form: CREAM
Applicant: SPEAR PHARMACEUTICALS
Active Ingredient(s): TRETINOIN
OTC/RX Status: RX

Original Abbreviated Application # 075265
Approval Date: 24-DEC-98
Trade Name: TRETINOIN
Dosage Form: CREAM
Applicant: SPEAR PHARMACEUTICALS
Active Ingredient(s): TRETINOIN
OTC/RX Status: RX

Original Abbreviated Application # 075325
Approval Date: 24-DEC-98
Trade Name: EMBELINE E
Dosage Form: CREAM
Applicant: HEALTHPOINT, LTD
Active Ingredient(s): CLOBETASOL PROPIONATE
OTC/RX Status: RX

Original Abbreviated Application # 075315
Approval Date: 23-DEC-98
Trade Name: AMIODARONE HYDROCHLORIDE
Dosage Form: TABLET
Applicant: EON LABS MANUFACTURING, INC
Active Ingredient(s): AMIODARONE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 074937
Approval Date: 22-DEC-98
Trade Name: IBUPROFEN
Dosage Form: SUSPENSION
Applicant: L PERRIGO CO
Active Ingredient(s): IBUPROFEN
OTC/RX Status: RX

Original Abbreviated Application # 040183
Approval Date: 22-DEC-98
Trade Name: METHYLPREDNISOLONE
Dosage Form: TABLET
Applicant: VINTAGE PHARMACEUTICALS INC
Active Ingredient(s): METHYLPREDNISOLONE
OTC/RX Status: RX

Original Abbreviated Application # 075137
Approval Date: 18-DEC-98
Trade Name: OXYBUTYNIN CHLORIDE
Dosage Form: SYRUP
Applicant: PHARMACEUTICAL ASSOC INC DIV BEACH PRODUCTS
Active Ingredient(s): OXYBUTYNIN CHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 074890
Approval Date: 18-DEC-98
Trade Name: CIMETIDINE
Dosage Form: TABLET
Applicant: TORPHARM INC
Active Ingredient(s): CIMETIDINE
OTC/RX Status: RX

Original Abbreviated Application # 075208
Approval Date: 17-DEC-98
Trade Name: RANITIDINE
Dosage Form: TABLET
Applicant: WOCKHARDT AMERICAS INC
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Antibiotic Application# 065006
Approval Date: 17-DEC-98
Trade Name: TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE
Dosage Form: SOLUTION
Applicant: TAYLOR PHARMACAL CO
Active Ingredient(s): POLYMYXIN B SULFATE; TRIMETHOPRIM
OTC/RX Status: RX

Original Abbreviated Application # 040191
Approval Date: 17-DEC-98
Trade Name: MEPERIDINE HCL
Dosage Form: TABLET
Applicant: VINTAGE PHARMACEUTICALS INC
Active Ingredient(s): MEPERIDINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075217
Approval Date: 16-DEC-98
Trade Name: IBUPROFEN
Dosage Form: SUSPENSION
Applicant: PERRIGO CO
Active Ingredient(s): IBUPROFEN
OTC/RX Status: RX

Original Abbreviated Application # 075100
Approval Date: 10-DEC-98
Trade Name: BROMOCRIPTINE MESYLATE
Dosage Form: CAPSULE
Applicant: LEK PHARMACEUTICAL AND CHEMICAL CO DD
Active Ingredient(s): BROMOCRIPTINE MESYLATE
OTC/RX Status: RX

Original Abbreviated Application # 075321
Approval Date: 04-DEC-98
Trade Name: SELEGILINE HYDROCHLORIDE
Dosage Form: CAPSULE
Applicant: TORPHARM INC
Active Ingredient(s): SELEGILINE HYDROCHLORIDE
OTC/RX Status: RX

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

Original Abbreviated Application #: 074507
Tentative Approval Date: 30-DEC-98
Trade Name: NICOTINE POLACRILEX
Dosage Form: GUM, CHEWING
Applicant: CIRCA PHARMACEUTICALS INC
Active Ingredient(s): NICOTINE POLACRILEX
OTC/RX Status: RX

Original Abbreviated Application #: 075242
Tentative Approval Date: 29-DEC-98
Trade Name: LABETALOL HYDROCHLORIDE
Dosage Form: INJECTABLE
Applicant: FAULDING PHARMACEUTICAL CO
Active Ingredient(s): LABETALOL HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application #: 075036
Tentative Approval Date: 29-DEC-98
Trade Name: CISPLATIN
Dosage Form: INJECTABLE
Applicant: BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
Active Ingredient(s): CISPLATIN
OTC/RX Status: RX

Original Abbreviated Application #: 075189
Tentative Approval Date: 24-DEC-98
Trade Name: NABUMETONE
Dosage Form: TABLET
Applicant:TEVA PHARMACEUTICALS USA
Active Ingredient(s): NABUMETONE
OTC/RX Status: RX

Original Abbreviated Application #: 074719
Tentative Approval Date: 23-DEC-98
Trade Name: PROPOFOL
Dosage Form: INJECTABLE
Applicant:BAXTER PHARMACEUTICAL PRODUCTS INC
Active Ingredient(s): PROPOFOL
OTC/RX Status: RX

Original Abbreviated Application #: 075011
Tentative Approval Date: 22-DEC-98
Trade Name: BUSPIRONE HYDROCHLORIDE
Dosage Form: TABLET
Applicant: ESI LEDERLE INC
Active Ingredient(s): BUSPIRONE HYDROCHLORIDE
OTC/RX Status: RX

Labeling Supplements to Original New Drug Applications

Application #: 018469 Labeling Supplement#: 032
To Original New Drug Application
Approval Date: 29-DEC-98
Trade Name: BSS PLUS
Dosage Form: SOLUTION
Applicant: ALCON LABORATORIES INC
Active Ingredient(s): SODIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM PHOSPHATE; SODIUM BICARBONATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; DEXTROSE; GLUTATHIONE DISULFIDE
OTC/RX Status: RX

Application #: 020236 Labeling Supplement#: 017
To Original New Drug Application
Approval Date: 24-DEC-98
Trade Name: SEREVENT
Dosage Form: AEROSOL, METERED
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): SALMETEROL XINAFOATE
OTC/RX Status: RX

Application #:050632Labeling Supplement#:010
To Original New Drug Application
Approval Date: 24-DEC-98
Trade Name: AZACTAM
Dosage Form: INJECTABLE
Applicant: BRISTOL-MYERS SQUIBB COMPANY
Active Ingredient(s): AZTREONAM
OTC/RX Status: RX

Application #: 019886 Labeling Supplement#: 013
To Original New Drug Application
Approval Date: 24-DEC-98
Trade Name: SYNAREL
Dosage Form: SPRAY, METERED
Applicant: SEARLE
Active Ingredient(s): NAFARELIN ACETATE
OTC/RX Status: RX

Application #: 020786 Labeling Supplement#: 003
To Original New Drug Application
Approval Date: 22-DEC-98
Trade Name: ALLEGRA-D
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: HOECHST MARION ROUSSEL INC
Active Ingredient(s): FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020625 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 22-DEC-98
Trade Name: ALLEGRA
Dosage Form: CAPSULE
Applicant: HOECHST MARION ROUSSEL INC
Active Ingredient(s): FEXOFENADINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020549 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 22-DEC-98
Trade Name: FLOVENT
Dosage Form: POWDER
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): FLUTICASONE PROPIONATE
OTC/RX Status: RX

Application #: 020548 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 22-DEC-98
Trade Name: FLOVENT
Dosage Form: AEROSOL, METERED
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): FLUTICASONE PROPIONATE
OTC/RX Status: RX

Application #: 019157 Labeling Supplement#: 013
To Original New Drug Application
Approval Date: 17-DEC-98
Trade Name: PEDIAPRED
Dosage Form: SOLUTION
Applicant: MEDEVA PHARMACEUTICALS INC
Active Ingredient(s): PREDNISOLONE SODIUM PHOSPHATE
OTC/RX Status: RX

Application #: 019157 Labeling Supplement#: 012
To Original New Drug Application
Approval Date: 17-DEC-98
Trade Name: PEDIAPRED
Dosage Form: SOLUTION
Applicant: MEDEVA PHARMACEUTICALS INC
Active Ingredient(s): PREDNISOLONE SODIUM PHOSPHATE
OTC/RX Status: RX

Application #: 019157 Labeling Supplement#: 011
To Original New Drug Application
Approval Date: 17-DEC-98
Trade Name: PEDIAPRED
Dosage Form: SOLUTION
Applicant: MEDEVA PHARMACEUTICALS INC
Active Ingredient(s): PREDNISOLONE SODIUM PHOSPHATE
OTC/RX Status: RX

Application #: 020356 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 16-DEC-98
Trade Name: SULAR
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: ZENECA LTD
Active Ingredient(s): NISOLDIPINE
OTC/RX Status: RX

Application #: 019901 Labeling Supplement#: 025
To Original New Drug Application
Approval Date: 16-DEC-98
Trade Name: ALTACE
Dosage Form: CAPSULE
Applicant: HOECHST MARION ROUSSEL
Active Ingredient(s): RAMIPRIL
OTC/RX Status: RX

Application #: 020903 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 09-DEC-98
Trade Name: REBETRON
Dosage Form: CAPSULE
Applicant: SCHERING PLOUGH RESEARCH INSTITUTE
Active Ingredient(s): INTERFERON ALFA-2B; RIBAVIRIN
OTC/RX Status: RX

Application #: 020903 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 09-DEC-98
Trade Name: REBETRON
Dosage Form: CAPSULE
Applicant: SCHERING PLOUGH RESEARCH INSTITUTE
Active Ingredient(s): INTERFERON ALFA-2B; RIBAVIRIN
OTC/RX Status: RX

Application #: 020151 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 09-DEC-98
Trade Name: EFFEXOR
Dosage Form: TABLET
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): VENLAFAXINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020151 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 09-DEC-98
Trade Name: EFFEXOR
Dosage Form: TABLET
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): VENLAFAXINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020151 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 09-DEC-98
Trade Name: EFFEXOR
Dosage Form: TABLET
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): VENLAFAXINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020151 Labeling Supplement#: 006
To Original New Drug Application
Approval Date: 09-DEC-98
Trade Name: EFFEXOR
Dosage Form: TABLET
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): VENLAFAXINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 019970 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 09-DEC-98
Trade Name: NITROGLYCERIN IN DEXTROSE 5%
Dosage Form: INJECTABLE
Applicant: BAXTER HEALTHCARE CORP
Active Ingredient(s): NITROGLYCERIN
OTC/RX Status: RX

Application #: 018537 Labeling Supplement#: 015
To Original New Drug Application
Approval Date: 09-DEC-98
Trade Name: TRIDIL
Dosage Form: INJECTABLE
Applicant: FAULDING PHARMACEUTICAL CO
Active Ingredient(s): NITROGLYCERIN
OTC/RX Status: RX

Application #: 011870 Labeling Supplement#: 031
To Original New Drug Application
Approval Date: 09-DEC-98
Trade Name: DIURIL
Dosage Form: SUSPENSION
Applicant: MERCK AND CO INC
Active Ingredient(s): CHLOROTHIAZIDE
OTC/RX Status: RX

Application #: 011145 Labeling Supplement#: 085
To Original New Drug Application
Approval Date: 09-DEC-98
Trade Name: DIURIL
Dosage Form: TABLET
Applicant: MERCK AND CO INC
Active Ingredient(s): CHLOROTHIAZIDE
OTC/RX Status: RX

Application #: 020757 Labeling Supplement#: 006
To Original New Drug Application
Approval Date: 08-DEC-98
Trade Name: AVAPRO
Dosage Form: TABLET
Applicant: BRISTOL-MYERS SQUIBB PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): IRBESARTAN
OTC/RX Status: RX

Application #: 020830 Labeling Supplement#: 006
To Original New Drug Application
Approval Date: 01-DEC-98
Trade Name: SINGULAIR
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): MONTELUKAST SODIUM
OTC/RX Status: RX

Application #: 020829 Labeling Supplement#: 006
To Original New Drug Application
Approval Date: 01-DEC-98
Trade Name: SINGULAIR
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): MONTELUKAST SODIUM
OTC/RX Status: RX

Application #: 020408 Labeling Supplement#: 015
To Original New Drug Application
Approval Date: 01-DEC-98
Trade Name: TRUSOPT
Dosage Form: SOLUTION
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): DORZOLAMIDE HYDROCHLORIDE
OTC/RX Status: RX