Drug Approvals for February 1998

Definitions and Notes

February 1998

Original New Drug Applications

Original Application #: 050750
Approval Date: 24-FEB-98
Trade Name: ZOSYN
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: LEDERLE PIPERACILLIN INC DIV AMERICAN CYANAMID CO
Active Ingredient(s): PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
OTC/RX Status: RX
Indication(s): Treatment of patients with moderate to severe infections caused by piperacillin resistant, piperacillin/tazobactam susceptible, B-lactamase producing strains of designated microorganisms and conditions specified in the labeling

Original Application #: 020805
Approval Date: 10-FEB-98
Trade Name: CIPRO HC
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: SUSPENSION/DROPS
Applicant: BAYER CORP PHARMACEUTICAL DIV
Active Ingredient(s): CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE
OTC/RX Status: RX
Indication(s): Treatment of acute otitis externa

Original Application #: 020763
Approval Date: 10-FEB-98
Trade Name: AMERGE
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): NARATRIPTAN HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): For the acute treatment of migraine headache

Original Application #: 020962
Approval Date: 04-FEB-98
Trade Name: EMLA
Chemical Type: 6
Therapeutic Potential: S
Dosage Form: DISC
Applicant: ASTRA USA, INC
Active Ingredient(s): LIDOCAINE; PRILOCAINE
OTC/RX Status: RX
Indication(s): For use as a topical anesthetic on normal intact skin for local anesthesia

Efficacy Supplemental New Drug Applications

Application #: 050542 Efficacy Supplement#: 011
Type: SE1 to Original New Drug Application
Approval Date: 27-FEB-98
Trade Name: AMOXIL
Dosage Form: CAPSULE; TABLET, CHEWABLE; POWDER FOR RECONSTITUTION
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): AMOXICILLIN
OTC/RX Status: RX
Efficacy Claim: For use in combination with lansoprazole (with or without clarithromycin) in patients with duodenal ulcer (defined as an active ulcer or history of an ulcer within one year) to eradicate Helicobacter pylori and reduce the risk of duodenal ulcer recurrence

Application #: 020137 Efficacy Supplement : 009
Type: SE2 to Original New Drug Application
Approval Date: 13-FEB-98
Trade Name: DEMADEX
Dosage Form: INJECTABLE
Applicant: BOEHRINGER MANNHEIM CORP THERAPEUTICS DIV
Active Ingredient(s): TORSEMIDE
OTC/RX Status: RX
Efficacy Claim: Provides for continuous infusion as an alternate method of administration

Application #: 020132 Efficacy Supplement#: 003
Type: SE2 to Original New Drug Application
Approval Date: 13-FEB-98
Trade Name: IMITREX
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): SUMATRIPTAN SUCCINATE
OTC/RX Status: RX
Efficacy Claim: Provides for a revision to the recommended usual adult dose

Application #: 050723 Efficacy Supplement#: 001
Type: SE1 to Original New Drug Application
Approval Date: 11-FEB-98
Trade Name: CELLCEPT
Dosage Form: TABLET
Applicant: SYNTEX INC
Active Ingredient(s): MYCOPHENOLATE MOFETIL
OTC/RX Status: RX
Efficacy Claim: Provides for the prophylaxis of organ rejection in patients receiving allogeneic cardiac transplant

Application #: 050722 Efficacy Supplement#: 002
Type: SE1 to Original New Drug Application
Approval Date: 11-FEB-98
Trade Name: CELLCEPT
Dosage Form: CAPSULE
Applicant: SYNTEX INC
Active Ingredient(s): MYCOPHENOLATE MOFETIL
OTC/RX Status: RX
Efficacy Claim: Provides for the prophylaxis of organ rejection in patients receiving allogeneic cardiac transplant

Application #: 020685 Efficacy Supplement#: 016
Type: SE1 to Original New Drug Application
Approval Date: 06-FEB-98
Trade Name: CRIXIVAN
Dosage Form: CAPSULE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): INDINAVIR SULFATE
OTC/RX Status: RX
Efficacy Claim: Indicated for the treatment of HIV infection in combination with antiretroviral agents

Application #: 020236 Efficacy Supplement#: 015
Type: SE1 to Original New Drug Application
Approval Date: 05-FEB-98
Trade Name: SEREVENT
Dosage Form: AEROSOL, METERED
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): SALMETEROL XINAFOATE
OTC/RX Status: RX
Efficacy Claim: For the long-term, twice-daily (morning and evening) administration in the maintenance treatment of bronchospasm associated with Chronic Obstructive Pulmonary Disease, including chronic bronchitis and emphysema

Application #: 020329 Efficacy Supplement#: 001
Type: SE1 to Original New Drug Application
Approval Date: 04-FEB-98
Trade Name: GLUCOTROL XL
Dosage Form: TABLET
Applicant: PFIZER INC
Active Ingredient(s): GLIPIZIDE
OTC/RX Status: RX
Efficacy Claim: Provides for combination therapy with metformin when satisfactory lowering of blood glucose is not achieved with Gulcotrol XL alone

Application #: 019941 Efficacy Supplement#: 008
Type: SE4 to Original New Drug Application
Approval Date: 04-FEB-98
Trade Name: EMLA
Dosage Form: CREAM
Applicant: ASTRA USA INC
Active Ingredient(s): LIDOCAINE; PRILOCAINE
OTC/RX Status: RX
Efficacy Claim: Pre-procedural application to adult male genital skin prior to site-specific subcutaneous infiltration with lidocaine for the removal of genital warts

Approvable Original New Drug Applications

Original Application #: 020793
Approvable Date: 23-FEB-98
Trade Name: CAFCIT
Dosage Form: INJECTABLE
Applicant: OREAD PEDIATRIC ROXANE DEVELOPMENT LTD PARTNERSHIP
Active Ingredient(s): CAFFEINE CITRATE
OTC/RX Status: RX

Original Application #: 020818
Approvable Date: 20-FEB-98
Trade Name: DIOVAN HCT
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORPORATION
Active Ingredient(s): HYDROCHLOROTHIAZIDE; VALSARTAN
OTC/RX Status: RX

Original Abbreviated New Drug Applications

Original Abbreviated Application # 074745
Approval Date: 27-FEB-98
Trade Name: MEGESTROL ACETATE
Dosage Form: TABLET
Applicant: PHARMACHEMIE BV
Active Ingredient(s): MEGESTROL ACETATE
OTC/RX Status: RX

Original Abbreviated Application # 040268
Approval Date: 27-FEB-98
Trade Name: PROCHLORPERAZINE MALEATE
Dosage Form: TABLET
Applicant: TRIGEN LABORATORIES INC
Active Ingredient(s): PROCHLORPERAZINE MALEATE
OTC/RX Status: RX

Original Abbreviated Application # 040255
Approval Date: 27-FEB-98
Trade Name: OXCODONE AND ASPIRIN
Dosage Form: TABLET
Applicant: ROYCE LABORATORIES INC
Active Ingredient(s): ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE
OTC/RX Status: RX

Original Abbreviated Application # 040201
Approval Date: 27-FEB-98
Trade Name: HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Dosage Form: TABLET
Applicant: MALLINCKRODT CHEMICAL INC
Active Ingredient(s): ACETAMINOPHEN; HYDROCODONE BITARTRATE
OTC/RX Status: RX

Original Abbreviated Application # 075005
Approval Date: 24-FEB-98
Trade Name: IOPAMIDOL
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): IOPAMIDOL
OTC/RX Status: RX

Original Abbreviated Application # 074936
Approval Date: 24-FEB-98
Trade Name: NAPROXEN
Dosage Form: TABLET, DELAYED RELEASE
Applicant: PUREPAC PHARMACEUTICAL CO DIV PUREPAC INC
Active Ingredient(s): NAPROXEN
OTC/RX Status: RX

Original Abbreviated Application # 040131
Approval Date: 24-FEB-98
Trade Name: EDROPHONIUM CHLORIDE
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): EDROPHONIUM CHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075061
Approval Date: 18-FEB-98
Trade Name: NAPROXEN
Dosage Form: TABLET, DELAYED RELEASE
Applicant: INVAMED INC
Active Ingredient(s): NAPROXEN
OTC/RX Status: RX

Original Abbreviated Application # 074279
Approval Date: 18-FEB-98
Trade Name: DOUBUTAMINE
Dosage Form: INJECTABLE
Applicant: MARSAM PHARMACEUTICALS INC
Active Ingredient(s): DOBUTAMINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Antibiotic Application# 064207
Approval Date: 18-FEB-98
Trade Name: CEFACLOR
Dosage Form: SUSPENSION
Applicant: MARSAM PHARMACEUTICALS INC
Active Ingredient(s): CEFACLOR
OTC/RX Status: RX

Original Abbreviated Antibiotic Application# 064206
Approval Date: 18-FEB-98
Trade Name: CEFACLOR
Dosage Form: SUSPENSION
Applicant: MARSAM PHARMACEUTICALS INC
Active Ingredient(s): CEFACLOR
OTC/RX Status: RX

Original Abbreviated Antibiotic Application# 064205
Approval Date: 18-FEB-98
Trade Name: CEFACLOR
Dosage Form: SUSPENSION
Applicant: MARSAM PHARMACEUTICALS INC
Active Ingredient(s): CEFACLOR
OTC/RX Status: RX

Original Abbreviated Antibiotic Application# 064204
Approval Date: 18-FEB-98
Trade Name: CEFACLOR
Dosage Form: SUSPENSION
Applicant: MARSAM PHARMACEUTICALS INC
Active Ingredient(s): CEFACLOR
OTC/RX Status: RX

Original Abbreviated Application # 073249
Approval Date: 13-FEB-98
Trade Name: CLOTRIMAZOLE
Dosage Form: TABLET
Applicant: COPLEY PHARMACEUTICAL
Active Ingredient(s): CLOTRIMAZOLE
OTC/RX Status: OTC

Original Abbreviated Application # 075104
Approval Date: 06-FEB-98
Trade Name: ETODOLACL
Dosage Form: TABLET
Applicant: MYLAN LABORATORIES INC
Active Ingredient(s): ETODOLAC
OTC/RX Status: RX

Original Abbreviated Application # 075033
Approval Date: 06-FEB-98
Trade Name: NITROGLYCERIN
Dosage Form: FILM, EXTENDED RELEASE
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): NITROGLYCERIN
OTC/RX Status: RX

Original Abbreviated Application # 040184
Approval Date: 06-FEB-98
Trade Name: TRIHEXYPHENIDYL HYDROCHLORIDE
Dosage Form: TABLET
Applicant: CIRCA PHARMACEUTICALS INC
Active Ingredient(s): TRIHEXYPHENIDYL HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 040029
Approval Date: 06-FEB-98
Trade Name: SODIUM POLYSTYRENE SULFONATE
Dosage Form: POWDER
Applicant: PADDOCK LABORATORIES INC
Active Ingredient(s): SODIUM POLYSTYRENE SULFONATE
OTC/RX Status: RX

Original Abbreviated Application # 074917
Approval Date: 03-FEB-98
Trade Name: FENTANYL CITRATE PRESERVATIVE FREE
Dosage Form: INJECTABLE
Applicant: MARSAM PHARMACEUTICALS INC
Active Ingredient(s): FENTANYL CITRATE
OTC/RX Status: RX

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

None

Labeling Supplements to Original New Drug Applications

Application #: 016295 Labeling Supplement#: 030
To Original New Drug Application
Approval Date: 25-FEB-98
Trade Name: DROXIA
Dosage Form: CAPSULE
Applicant: ER SQUIBB AND SONS INC
Active Ingredient(s): HYDROXYUREA
OTC/RX Status: RX

Application #: 050622 Labeling Supplement#: 013
To Original New Drug Application
Approval Date: 27-FEB-98
Trade Name: SUPRAX
Dosage Form: SUSPENSION
Applicant: LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
Active Ingredient(s): CEFIXIME
OTC/RX Status: RX

Application #: 050621 Labeling Supplement#: 021
To Original New Drug Application
Approval Date: 27-FEB-98
Trade Name: SUPRAX
Dosage Form: TABLET
Applicant: LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
Active Ingredient(s): CEFIXIME
OTC/RX Status: RX

Application #: 050542 Labeling Supplement#: 010
To Original New Drug Application
Approval Date: 27-FEB-98
Trade Name: AMOXIL
Dosage Form: CAPSULE; TABLET, CHEWABLE; POWDER FOR RECONSTITUTION
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): AMOXICILLIN
OTC/RX Status: RX

Application #: 050542 Labeling Supplement#: 005
To Original New Drug Application
Approval Date: 27-FEB-98
Trade Name: AMOXIL
Dosage Form: CAPSULE; TABLET, CHEWABLE; POWDER FOR RECONSTITUTION
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): AMOXICILLIN
OTC/RX Status: RX

Application #: 020857 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 27-FEB-98
Trade Name: COMBIVIR
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): LAMIVUDINE; ZIDOVUDINE
OTC/RX Status: RX

Application #: 011613 Labeling Supplement#: 023
To Original New Drug Application
Approval Date: 27-FEB-98
Trade Name: IONAMIN
Dosage Form: CAPSULE
Applicant: MEDEVA PHARMACEUTICALS INC
Active Ingredient(s): PHENTERMINE RESIN
OTC/RX Status: RX

Application #: 020386 Labeling Supplement#: 006
To Original New Drug Application
Approval Date: 25-FEB-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 #: 019885 Labeling Supplement#: 015
To Original New Drug Application
Approval Date: 25-FEB-98
Trade Name: ACCUPRIL
Dosage Form: TABLET
Applicant: PARKE DAVIS DIV WARNER LAMBERT CO
Active Ingredient(s): QUINAPRIL HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020402 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 23-FEB-98
Trade Name: PROVEL
Dosage Form: CAPSULE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): IBUPROFEN POTASSIUM
OTC/RX Status: OTC

Application #: 020563 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 20-FEB-98
Trade Name: HUMALOG
Dosage Form: INJECTABLE
Applicant: ELI LILLY AND COMPANY
Active Ingredient(s): INSULIN LISPRO
OTC/RX Status: RX

Application #: 019963 Labeling Supplement#: 003
To Original New Drug Application
Approval Date: 20-FEB-98
Trade Name: RENOVA
Dosage Form: CREAM
Applicant: JOHNSON AND JOHNSON COMSUMER PRODUCTS INC
Active Ingredient(s): TRETINOIN
OTC/RX Status: RX

Application #: 019717 Labeling Supplement#: 024
To Original New Drug Application
Approval Date: 20-FEB-98
Trade Name: HUMULIN 70/30
Dosage Form: INJECTABLE
Applicant: ELI LILLY AND COMPANY
Active Ingredient(s): INSULIN BIOSYNTHETIC HUMAN; INSULIN SUSP ISOPHANE BIOSYNTHETIC HUMAN
OTC/RX Status: OTC

Application #: 018781 Labeling Supplement#: 048
To Original New Drug Application
Approval Date: 20-FEB-98
Trade Name: HUMULIN N
Dosage Form: INJECTABLE
Applicant: ELI LILLY AND COMPANY
Active Ingredient(s): INSULIN SUSP ISOPHANE BIOSYNTHETIC HUMAN
OTC/RX Status: OTC

Application #: 018780 Labeling Supplement#: 057
To Original New Drug Application
Approval Date: 20-FEB-98
Trade Name: HUMULIN R
Dosage Form: INJECTABLE
Applicant: ELI LILLY AND COMPANY
Active Ingredient(s): INSULIN BIOSYNTHETIC HUMAN
OTC/RX Status: OTC

Application #: 020667 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 19-FEB-98
Trade Name: MIRAPEX
Dosage Form: TABLET
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): PRAMIPEXOLE DIHYDROCHLORIDE
OTC/RX Status: RX

Application #: 020064 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 17-FEB-98
Trade Name: MACROBID
Dosage Form: CAPSULE
Applicant: PROCTER AND GAMBLE PHARMACEUTICALS INC SUB PROCTER AND GAMBLE CO
Active Ingredient(s): NITROFURANTOIN, MACROCRYSTALLINE; NITROFURANTOIN
OTC/RX Status: RX

Application #: 020064 Labeling Supplement#: 005
To Original New Drug Application
Approval Date: 17-FEB-98
Trade Name: MACROBID
Dosage Form: CAPSULE
Applicant: PROCTER AND GAMBLE PHARMACEUTICALS INC SUB PROCTER AND GAMBLE CO
Active Ingredient(s): NITROFURANTOIN, MACROCRYSTALLINE; NITROFURANTOIN
OTC/RX Status: RX

Application #: 016620 Labeling Supplement#: 058
To Original New Drug Application
Approval Date: 17-FEB-98
Trade Name: MACRODANTIN
Dosage Form: CAPSULE
Applicant: PROCTER AND GAMBLE CO
Active Ingredient(s): NITROFURANTOIN, MACROCRYSTALLINE
OTC/RX Status: RX

Application #: 016620 Labeling Supplement#: 056
To Original New Drug Application
Approval Date: 17-FEB-98
Trade Name: MACRODANTIN
Dosage Form: CAPSULE
Applicant: PROCTER AND GAMBLE CO
Active Ingredient(s): NITROFURANTOIN, MACROCRYSTALLINE
OTC/RX Status: RX

Application #: 011613 Labeling Supplement#: 024
To Original New Drug Application
Approval Date: 17-FEB-98
Trade Name: IONAMIN
Dosage Form: CAPSULE
Applicant: MEDEVA PHARMACEUTICALS INC
Active Ingredient(s): PHENTERMINE RESIN COMPLEX
OTC/RX Status: RX

Application #: 008693 Labeling Supplement#: 028
To Original New Drug Application
Approval Date: 17-FEB-98
Trade Name: FURADANTIN
Dosage Form: TABLET
Applicant: PROCTER AND GAMBLE PHARMACEUTICALS INC SUB PROCTER AND GAMBLE CO
Active Ingredient(s): NITROFURANTOIN
OTC/RX Status: RX

Application #: 008693 Labeling Supplement#: 026
To Original New Drug Application
Approval Date: 17-FEB-98
Trade Name: FURADANTIN
Dosage Form: TABLET
Applicant: PROCTER AND GAMBLE PHARMACEUTICALS INC SUB PROCTER AND GAMBLE CO
Active Ingredient(s): NITROFURANTOIN
OTC/RX Status: RX

Application #: 050629 Labeling Supplement#: 006
To Original New Drug Application
Approval Date: 13-FEB-98
Trade Name: ADRIAMYCIN PFS
Dosage Form: INJECTABLE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): DOXORUBICIN HYDROCHLORIDE
OTC/RX Status: RX

Application #: 050467 Labeling Supplement#: 062
To Original New Drug Application
Approval Date: 13-FEB-98
Trade Name: ADRIAMYCIN RDF
Dosage Form: INJECTABLE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): DOXORUBICIN HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020136 Labeling Supplement#: 011
To Original New Drug Application
Approval Date: 13-FEB-98
Trade Name: DEMADEX
Dosage Form: TABLET
Applicant: BOEHRINGER MANNHEIM CORP THERAPEUTICS DIV
Active Ingredient(s): TORSEMIDE
OTC/RX Status: RX

Application #: 017481 Labeling Supplement#: 038
To Original New Drug Application
Approval Date: 13-FEB-98
Trade Name: VERMOX
Dosage Form: TABLET, CHEWABLE
Applicant: JANSSEN RESEARCH FDN DIV JOHNSON AND JOHNSON
Active Ingredient(s): MEBENDAZOLE
OTC/RX Status: RX

Application #: 020680 Labeling Supplement#: 010
To Original New Drug Application
Approval Date: 12-FEB-98
Trade Name: NORVIR
Dosage Form: CAPSULE
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): RITONAVIR
OTC/RX Status: RX

Application #: 020659 Labeling Supplement#: 012
To Original New Drug Application
Approval Date: 12-FEB-98
Trade Name: NORVIR
Dosage Form: SOLUTION
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): RITONAVIR
OTC/RX Status: RX

Application #:020667 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 12-FEB-98
Trade Name: MIRAPEX
Dosage Form: TABLET
Applicant: PHARMACIA AND UPJOHN
Active Ingredient(s): PRAMIPEXOLE DIHYDROCHLORIDE
OTC/RX Status: RX

Application #: 019951 Labeling Supplement#: 010
To Original New Drug Application
Approval Date: 12-FEB-98
Trade Name: RETROVIR
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ZIDOVUDINE
OTC/RX Status: RX

Application #: 050726 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 11-FEB-98
Trade Name: AUGMENTIN '200'; AUGMENTIN '400'
Dosage Form: TABLET, CHEWABLE
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): AMOXICILLIN; CLAVULANATE POTASSIUM
OTC/RX Status: RX

Application #: 050725 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 11-FEB-98
Trade Name: AUGMENTIN '200'; AUGMENTIN '400'
Dosage Form: POWDER, FOR RECONSTITUTION
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): AMOXICILLIN; CLAVULANATE POTASSIUM
OTC/RX Status: RX

Application #: 050720 Labeling Supplement#: 003
To Original New Drug Application
Approval Date: 11-FEB-98
Trade Name: AUGMENTIN '875'
Dosage Form: TABLET
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): AMOXICILLIN; CLAVULANATE POTASSIUM
OTC/RX Status: RX

Application #: 050597 Labeling Supplement#: 028
To Original New Drug Application
Approval Date: 11-FEB-98
Trade Name: AUGMENTIN '125'; AUGMENTIN '250'
Dosage Form: TABLET, CHEWABLE
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): AMOXICILLIN; CLAVULANATE POTASSIUM
OTC/RX Status: RX

Application #: 050575 Labeling Supplement#: 023
To Original New Drug Application
Approval Date: 11-FEB-98
Trade Name: AUGMENTIN '125'; AUGMENTIN '250'
Dosage Form: POWDER, FOR RECONSTITUTION
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): AMOXICILLIN; CLAVULANATE POTASSIUM
OTC/RX Status: RX

Application #: 050564 Labeling Supplement#: 032
To Original New Drug Application
Approval Date: 11-FEB-98
Trade Name: AUGMENTIN '250'; AUGMENTIN '500'
Dosage Form: TABLET
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): AMOXICILLIN; CLAVULANATE POTASSIUM
OTC/RX Status: RX

Application #: 020705 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 11-FEB-98
Trade Name: RESCRIPTOR
Dosage Form: TABLET
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): DELAVIRDINE MESYLATE
OTC/RX Status: RX

Application #: 020014 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 11-FEB-98
Trade Name: MAXAIR
Dosage Form: AEROSOL, METERED
Applicant: 3M PHARMACEUTICALS INC
Active Ingredient(s): PIRBUTEROL ACETATE
OTC/RX Status: RX

Application #: 019009 Labeling Supplement#: 005
To Original New Drug Application
Approval Date: 11-FEB-98
Trade Name: MAXAIR
Dosage Form: AEROSOL, METERED
Applicant: 3M PHARMACEUTICALS INC
Active Ingredient(s): PIRBUTEROL ACETATE
OTC/RX Status: RX

Application #: 020357 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 10-FEB-98
Trade Name: GLUCOPHAGE
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): METFORMIN HYDROCHLORIDE
OTC/RX Status: RX

Application #: 018226 Labeling Supplement#: 019
To Original New Drug Application
Approval Date: 10-FEB-98
Trade Name: BUMEX
Dosage Form: INJECTABLE
Applicant: HOFFMANN LA ROCHE INC
Active Ingredient(s): BUMETANIDE
OTC/RX Status: RX

Application #: 018225 Labeling Supplement#: 013
To Original New Drug Application
Approval Date: 10-FEB-98
Trade Name: BUMEX
Dosage Form: TABLET
Applicant: HOFFMANN LA ROCHE INC
Active Ingredient(s): BUMETANIDE
OTC/RX Status: RX

Application #: 019384 Labeling Supplement#: 026
To Original New Drug Application
Approval Date: 09-FEB-98
Trade Name: NOROXIN
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): NORFLOXACIN
OTC/RX Status: RX

Application #: 020685 Labeling Supplement#: 018
To Original New Drug Application
Approval Date: 06-FEB-98
Trade Name: CRIXIVAN
Dosage Form: CAPSULE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): INDINAVIR SULFATE
OTC/RX Status: RX

Application #: 020685 Labeling Supplement#: 017
To Original New Drug Application
Approval Date: 06-FEB-98
Trade Name: CRIXIVAN
Dosage Form: CAPSULE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): INDINAVIR SULFATE
OTC/RX Status: RX

Application #: 020541 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 06-FEB-98
Trade Name: ARIMIDEX
Dosage Form: TABLET
Applicant: ZENECA PHARMACEUTICALS DIV ZENECA INC
Active Ingredient(s): ANASTROZOLE
OTC/RX Status: RX

Application #: 020719 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 04-FEB-98
Trade Name: PRELAY
Dosage Form: TABLET
Applicant: SANKYO USA CORP
Active Ingredient(s): TROGLITAZONE
OTC/RX Status: RX

Application #: 020482 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 04-FEB-98
Trade Name: PRECOSE
Dosage Form: TABLET
Applicant: BAYER CORP
Active Ingredient(s): ACARBOSE
OTC/RX Status: RX

Application #: 020413 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 04-FEB-98
Trade Name: ZERIT
Dosage Form: SOLUTION
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): STAVUDINE
OTC/RX Status: RX

Application #: 020412 Labeling Supplement#: 005
To Original New Drug Application
Approval Date: 04-FEB-98
Trade Name: ZERIT
Dosage Form: CAPSULE
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): STAVUDINE
OTC/RX Status: RX

Application #: 019941 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 04-FEB-98
Trade Name: EMLA
Dosage Form: CREAM
Applicant: ASTRA USA INC
Active Ingredient(s): LIDOCAINE; PRILOCAINE
OTC/RX Status: RX

Application #: 019941 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 04-FEB-98
Trade Name: EMLA
Dosage Form: CREAM
Applicant: ASTRA USA INC
Active Ingredient(s): LIDOCAINE; PRILOCAINE
OTC/RX Status: RX

Application #: 020584 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 03-FEB-98
Trade Name: LODINE XL
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): ETODOLAC
OTC/RX Status: RX

Application #: 018655 Labeling Supplement#: 030
To Original New Drug Application
Approval Date: 03-FEB-98
Trade Name: NORPACE CR
Dosage Form: CAPSULE, EXTENDED RELEASE
Applicant: GD SEARLE AND CO
Active Ingredient(s): DISOPYRAMIDE PHOSPHATE
OTC/RX Status: RX

Application #: 017447 Labeling Supplement#: 052
To Original New Drug Application
Approval Date: 03-FEB-98
Trade Name: NORPACE
Dosage Form: CAPSULE
Applicant: GD SEARLE AND CO
Active Ingredient(s): DISOPYRAMIDE PHOSPHATE
OTC/RX Status: RX

Application #: 050522 Labeling Supplement#: 018
To Original New Drug Application
Approval Date: 02-FEB-98
Trade Name: CECLOR
Dosage Form: POWDER, FOR RECONSTITUTION
Applicant: ELI LILLY AND CO
Active Ingredient(s): CEFACLOR
OTC/RX Status: RX

Application #: 050521 Labeling Supplement#: 021
To Original New Drug Application
Approval Date: 02-FEB-98
Trade Name: CECLOR
Dosage Form: CAPSULE
Applicant: ELI LILLY AND CO
Active Ingredient(s): CEFACLOR
OTC/RX Status: RX

Application #: 020702 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 02-FEB-98
Trade Name: LIPITOR
Dosage Form: TABLET
Applicant: PARKE DAVIS PHARMACEUTICAL RESEARCH DIV WARNER LAMBERT CO
Active Ingredient(s): ATORVASTATIN CALCIUM
OTC/RX Status: RX

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