Drug Approvals for May 1997

Definitions and Notes

May 1997

Original New Drug Applications

Original Application #: 020497
Approval Date: 29-MAY-97
Trade Name: FARESTON
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: ORION CORP
Active Ingredient(s): TOREMIFENE CITRATE
OTC/RX Status: RX
Indication(s): Treatment of metastatic breast cancer in postmenopausal women with estrogen receptor positive or receptor unknown tumors

Original Application #: 020227
Approval Date: 23-MAY-97
Trade Name: NORMIFLO
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): ARDEPARIN SODIUM
OTC/RX Status: RX
Indication(s): Prevention of deep venous thrombosis which may lead to pulmonary embolism following knee replacement surgery

Original Application #: 050736
Approval Date: 22-MAY-97
Trade Name: NEORAL
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: SOLUTION
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): CYCLOSPORINE
OTC/RX Status: RX
Indication(s): Treatment of severe active, rheumatoid arthritis where the disease has not adequately responded to methotrexate

Original Application #: 050735
Approval Date: 22-MAY-97
Trade Name: NEORAL
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: CAPSULE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): CYCLOSPORINE
OTC/RX Status: RX
Indication(s): Treatment of severe active, rheumatoid arthritis where the disease has not adequately responded to methotrexate

Original Application #: 020711
Approval Date: 14-MAY-97
Trade Name: ZYBAN
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): BUPROPION HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): For use as an aid to smoking cessation treatment

Original Application #: 020756
Approval Date: 13-MAY-97
Trade Name: CRINONE
Chemical Type: 3
Therapeutic Potential: P
Dosage Form: GEL
Applicant: COLUMBIA RESEARCH LABORATORIES INC
Active Ingredient(s): PROGESTERONE
OTC/RX Status: RX
Indication(s):Proesterone supplementation or replacement as part of an Assistant Reproductive Technology (ART) treatment for infertile women with progesterone deficiency

Original Application #: 020617
Approval Date: 09-MAY-97
Trade Name: PYTEST
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: CAPSULE
Applicant: TRI MED SPECIALTIES INC
Active Ingredient(s): UREA C-14
OTC/RX Status: RX
Indication(s): For use in the detection of gastric urease as an aid in the diagnosis of Helicobacter Pylori infection in the human stomach

Original Application #: 020714
Approval Date: 02-MAY-97
Trade Name: NICOTROL
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: INHALATION
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): NICOTINE
OTC/RX Status: RX
Indication(s): Aid to smoking cessation

Efficacy Supplemental New Drug Applications

Application #:020517Efficacy Supplement#:002
Type: SE2 to Original New Drug Application
Approval Date: 30-MAY-97
Trade Name: LUPRON DEPOT
Dosage Form: INJECTABLE
Applicant: TAP HOLDINGS INC
Active Ingredient(s): LEUPROLIDE ACETATE
OTC/RX Status: RX
Efficacy Claim: For the palliative treatment of advanced prostatic cancer

Application #:019927Efficacy Supplement#:012
Type: SE1 to Original New Drug Application
Approval Date: 30-MAY-97
Trade Name: NIZORAL
Dosage Form: SHAMPOO
Applicant: JANSSEN RESEARCH FDN DIV JOHNSON AND JOHNSON
Active Ingredient(s): KETOCONAZOLE
OTC/RX Status: RX
Efficacy Claim: Treatment of tinea (pityriasis) versicolor caused by or presumed to be caused by Pityrosporum orbiculare (also known as Malassezia furfur or M. orbiculare)

Application #:020297Efficacy Supplement#:001
Type: SE1 to Original New Drug Application
Approval Date: 29-MAY-97
Trade Name: COREG
Dosage Form: TABLET
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): CARVEDILOL
OTC/RX Status: RX
Efficacy Claim: For the new indication of congestive heart failure and a new dosage strength of 3.125 mg

Application #:019785Efficacy Supplement#:006
Type: SE5 to Original New Drug Application
Approval Date: 23-MAY-97
Trade Name: MIRALUMA
Dosage Form: INJECTABLE
Applicant: DUPONT RADIOPHARMACEUTICALS DIV
Active Ingredient(s): TECHNETIUM TC-99M SESTAMIBI KIT
OTC/RX Status: RX
Efficacy Claim: Indicated for planar imaging as a second line diagnostic drug after mammography to assist in the evaluation of breast lesions in patients with an abnormal mammogram or a palpable breast mass

Application #: 050679 Efficacy Supplement #: 002
Type: SE1 to Original New Drug Application
Approval Date: 16-MAY-97
Trade Name: MAXIPIME
Dosage Form: INJECTABLE
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): CEFEPIME HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim: Empiric use as monotherapy in febrile neutropenic patients

Application #: 020208 Efficacy Supplement #: 006
Type: SE2 to Original New Drug Application
Approval Date: 16-MAY-97
Trade Name: METROGEL-VAGINAL
Dosage Form: GEL
Applicant: 3M PHARMACEUTICALS INC
Active Ingredient(s): METRONIDAZOLE
OTC/RX Status: RX
Efficacy Claim: Once-a-day dosing regimen

Application #: 020406 Efficacy Supplement#: 011
Type: SE1 to Original New Drug Application
Approval Date: 08-MAY-97
Trade Name: PREVACID
Dosage Form: CAPSULE
Applicant: TAP HOLDINGS INC
Active Ingredient(s): LANSOPRAZOLE
OTC/RX Status: RX
Efficacy Claim: Acute treatment of active benign gastric ulcer

Application #: 020164 Efficacy Supplement#: 008
Type: SE1 to Original New Drug Application
Approval Date: 06-MAY-97
Trade Name: LOVENOX
Dosage Form: INJECTABLE
Applicant: RHONE POULENC RORER PHARMACEUTICALS INC
Active Ingredient(s): ENOXAPARIN SODIUM
OTC/RX Status: RX
Efficacy Claim: The prevention of deep vein thrombosis, which may lead to pulmonary embolism, in patients undergoing abdominal surgery who are at risk for thromboembolic complications and a new dosage regimen, 40mg once daily, for this indication

Approvable Original New Drug Applications

Original Application #: 020310
Approvable Date: 15-MAY-97
Trade Name: NIZORAL A-D
Dosage Form: SHAMPOO
Applicant: JOHNSON AND JOHNSON CONSUMER PRODUCTS INC
Active Ingredient(s): KETOCONAZOLE
OTC/RX Status: OTC

Original Application #: 020420
Approvable Date: 12-MAY-97
Trade Name: GENESA
Dosage Form: INJECTABLE
Applicant: GENSIA INC
Active Ingredient(s): ARBUTAMINE HYDROCHLORIDE
OTC/RX Status: RX

Original Application #: 020148
Approvable Date: 09-MAY-97
Trade Name: MIGRANAL
Dosage Form: SPRAY
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): DIHYDROERGOTAMINE MESYLATE
OTC/RX Status: RX

Original Application #: 020699
Approvable Date: 02-MAY-97
Trade Name: EFFEXOR XR
Dosage Form: CAPSULE
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): VENLAFAXINE HYDROCHLORIDE
OTC/RX Status: RX

Original Application #: 020537
Approvable Date: 02-MAY-97
Trade Name: SPORANOX
Dosage Form: CAPSULE
Applicant: JANSSEN RESEARCH FDN DIV JOHNSON AND JOHNSON
Active Ingredient(s): ITRACONAZOLE
OTC/RX Status: RX

Original Abbreviated New Drug Applications

Original Abbreviated Application # 074677
Approval Date: 30-MAY-97
Trade Name: CAPTOPRIL
Dosage Form: TABLET
Applicant: STASON INDUSTRIAL CORP
Active Ingredient(s): CAPTOPRIL
OTC/RX Status: RX

Original Abbreviated Antibiotic Application# 064125
Approval Date: 30-MAY-97
Trade Name: CERFUROXIME SODIUM
Dosage Form: INJECTABLE
Applicant: GC HANFORD MANUFACTURING CO
Active Ingredient(s): CEFUROXIME SODIUM
OTC/RX Status: RX

Original Abbreviated Antibiotic Application# 064124
Approval Date: 30-MAY-97
Trade Name: CEFUROXIME SODIUM
Dosage Form: INJECTABLE
Applicant: GC HANFORD MANUFACTURING CO
Active Ingredient(s): CEFUROXIME SODIUM
OTC/RX Status: RX

Original Abbreviated Application # 040190
Approval Date: 30-MAY-97
Trade Name: PHENTERMINE HCL
Dosage Form: TABLET
Applicant: AMIDE PHARMACEUTICAL INC
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 074748
Approval Date: 29-MAY-97
Trade Name: CAPTOPRIL
Dosage Form: TABLET
Applicant: EGIS PHARMACEUTICALS
Active Ingredient(s): CAPTOPRIL
OTC/RX Status: RX

Original Abbreviated Application # 071804
Approval Date: 29-MAY-97
Trade Name: DESIPRAMINE HCL
Dosage Form: TABLET
Applicant: SIDMAK LABORATORIES INC
Active Ingredient(s): DESIPRAMINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 071803
Approval Date: 29-MAY-97
Trade Name: DESIPRAMINE HCL
Dosage Form: TABLET
Applicant: SIDMAK LABORATORIES INC
Active Ingredient(s): DESIPRAMINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Antibiotic Application# 064150
Approval Date: 28-MAY-97
Trade Name: RIFAMPIN
Dosage Form: CAPSULE
Applicant: EON LABORATORIES MANUFACTURING INC
Active Ingredient(s): RIFAMPIN
OTC/RX Status: RX

Original Abbreviated Application # 040195
Approval Date: 28-MAY-97
Trade Name: ACETAZOLAMIDE
Dosage Form: TABLET
Applicant: TARO PHARMACEUTICAL INDUSTRIES LTD
Active Ingredient(s): ACETAZOLAMIDE
OTC/RX Status: RX

Original Abbreviated Application # 074932
Approval Date: 16-MAY-97
Trade Name: ETODOLAC
Dosage Form: CAPSULE
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): ETODOLAC
OTC/RX Status: RX

Original Abbreviated Application # 074761
Approval Date: 16-MAY-97
Trade Name: KETOROLAC TROMETHAMINE
Dosage Form: TABLET
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): KETOROLAC TROMETHAMINE
OTC/RX Status: RX

Original Abbreviated Application # 074754
Approval Date: 16-MAY-97
Trade Name: KETOROLAC TROMETHAMINE
Dosage Form: TABLET
Applicant: LEMMON CO SUB TAG PHARMACEUTICAL INC
Active Ingredient(s): KETOROLAC TROMETHAMINE
OTC/RX Status: RX

Original Abbreviated Application # 074560
Approval Date: 16-MAY-97
Trade Name: FLURBIPROFEN
Dosage Form: TABLET
Applicant: WARNER CHILCOTT INC
Active Ingredient(s): FLURBIPROFEN
OTC/RX Status: RX

Original Abbreviated Application # 074220
Approval Date: 16-MAY-97
Trade Name: CORMAX
Dosage Form: CREAM
Applicant: HEALTHPOINT LTD
Active Ingredient(s): CLOBETASOL PROPIONATE
OTC/RX Status: RX

Original Abbreviated Application # 074760
Approval Date: 15-MAY-97
Trade Name: MICONAZOLE NITRATE
Dosage Form: CREAM
Applicant: L PERRIGO CO
Active Ingredient(s): MICONAZOLE NITRATE
OTC/RX Status: RX

Original Abbreviated Application # 040163
Approval Date: 12-MAY-97
Trade Name: MEPERIDINE HCL
Dosage Form: INJECTABLE
Applicant: MALLINCKRODT CHEMICAL INC
Active Ingredient(s): MEPERIDINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Antibiotic Application# 064153
Approval Date: 09-MAY-97
Trade Name: BACIIM
Dosage Form: INJECTABLE
Applicant: PHARMA TEK INC
Active Ingredient(s): BACITRACIN
OTC/RX Status: RX

Original Abbreviated Application # 074910
Approval Date: 02-MAY-97
Trade Name: DILTIAZEM HYDROCHLORIDE
Dosage Form: CAPSULE
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): DILTIAZEM HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 040207
Approval Date: 01-MAY-97
Trade Name: PROCHLORPERAZINE MALEATE
Dosage Form: TABLET
Applicant: DURAMED PHARMACEUTICALS INC
Active Ingredient(s): PROCHLORPERAZINE MALEATE
OTC/RX Status: RX

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

Original Abbreviated Application #: 074656
Tentative Approval Date: 29-MAY-97
Trade Name: CISPLATIN
Dosage Form: INJECTABLE
Applicant: PHARMACHEMIE BV
Active Ingredient(s): CISPLATIN
OTC/RX Status: RX

Original Abbreviated Application #: 074896
Tentative Approval Date: 19-MAY-97
Trade Name: CAPTOPRIL; HYDROCHLOROTHIAZIDE
Dosage Form: TABLET
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): CAPTOPRIL; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX

Labeling Supplements to Original New Drug Applications

Application #:020239Labeling Supplement#:006
To Original New Drug Application
Approval Date: 30-MAY-97
Trade Name: KYTRIL
Dosage Form: INJECTABLE
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): GRANISETRON HYDROCHLORIDE
OTC/RX Status: RX

Application #:019389Labeling Supplement#:017
To Original New Drug Application
Approval Date: 30-MAY-97
Trade Name: BECONASE AQ
Dosage Form: SPRAY, METERED
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): BECLOMETHASONE DIPROPIONATE MONOHYDRATE
OTC/RX Status: RX

Application #:011751Labeling Supplement#:095
To Original New Drug Application
Approval Date: 30-MAY-97
Trade Name: PROLIXIN
Dosage Form: TABLET
Applicant: APOTHECON INC DIV BRISTOL MYERS SQUIBB
Active Ingredient(s): FLUPHENAZINE HYDROCHLORIDE
OTC/RX Status: RX

Application #:050665Labeling Supplement#:017
To Original New Drug Application
Approval Date: 29-MAY-97
Trade Name: CEFZIL
Dosage Form: POWDER FOR RECONSTITUTION
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): CEFPROZIL
OTC/RX Status: RX

Application #:050664Labeling Supplement#:017
To Original New Drug Application
Approval Date: 29-MAY-97
Trade Name: CEFZIL
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): CEFPROZIL
OTC/RX Status: RX

Application #:020482Labeling Supplement#:004
To Original New Drug Application
Approval Date: 29-MAY-97
Trade Name: PRECOSE
Dosage Form: TABLET
Applicant: BAYER CORPORATION
Active Ingredient(s): ACARBOSE
OTC/RX Status: RX

Application #:020323Labeling Supplement#:014
To Original New Drug Application
Approval Date: 29-MAY-97
Trade Name: VIVELLE
Dosage Form: FILM, EXTENDED RELEASE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): ESTRADIOL
OTC/RX Status: RX

Application #:020089Labeling Supplement#:011
To Original New Drug Application
Approval Date: 29-MAY-97
Trade Name: ZOVIRAX
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ACYCLOVIR
OTC/RX Status: RX

Application #:019909Labeling Supplement#:012
To Original New Drug Application
Approval Date: 29-MAY-97
Trade Name: ZOVIRAX
Dosage Form: SUSPENSION
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ACYCLOVIR
OTC/RX Status: RX

Application #:018828Labeling Supplement#:020
To Original New Drug Application
Approval Date: 29-MAY-97
Trade Name: ZOVIRAX
Dosage Form: CAPSULE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ACYCLOVIR
OTC/RX Status: RX

Application #:020164Labeling Supplement#:017
To Original New Drug Application
Approval Date: 27-MAY-97
Trade Name: LOVENOX
Dosage Form: INJECTABLE
Applicant: RHONE POULENC RORER PHARMACEUTICALS INC
Active Ingredient(s): ENOXAPARIN SODIUM
OTC/RX Status: RX

Application #:020164Labeling Supplement#:006
To Original New Drug Application
Approval Date: 27-MAY-97
Trade Name: LOVENOX
Dosage Form: INJECTABLE
Applicant: RHONE POULENC RORER PHARMACEUTICALS INC
Active Ingredient(s): ENOXAPARIN SODIUM
OTC/RX Status: RX

Application #:019753Labeling Supplement#:008
To Original New Drug Application
Approval Date: 27-MAY-97
Trade Name: ETHMOZINE
Dosage Form: TABLET
Applicant: ROBERTS LABORATORIES INC
Active Ingredient(s): MORICIZINE HYDROCHLORIDE
OTC/RX Status: RX

Application #:018596Labeling Supplement#:026
To Original New Drug Application
Approval Date: 27-MAY-97
Trade Name: INTAL
Dosage Form: SOLUTION
Applicant: RHONE POULENC RORER CENTRAL RESEARCH
Active Ingredient(s): CROMOLYN SODIUM
OTC/RX Status: RX

Application #:006035Labeling Supplement#:060
To Original New Drug Application
Approval Date: 27-MAY-97
Trade Name: METHERGINE
Dosage Form: INJECTABLE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): METHYLERGONOVINE MALEATE
OTC/RX Status: RX

Application #:006035Labeling Supplement#:060
To Original New Drug Application
Approval Date: 27-MAY-97
Trade Name: METHERGINE
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): METHYLERGONOVINE MALEATE
OTC/RX Status: RX

Application #:019766Labeling Supplement#:017
To Original New Drug Application
Approval Date: 23-MAY-97
Trade Name: ZOCOR
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): SIMVASTATIN
OTC/RX Status: RX

Application #:019297Labeling Supplement#:016
To Original New Drug Application
Approval Date: 23-MAY-97
Trade Name: NOVANTRONE
Dosage Form: INJECTABLE
Applicant: IMMUNEX CORP
Active Ingredient(s): MITOXANTRONE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 050686 Labeling Supplement #: 002
To Original New Drug Application
Approval Date: 21-MAY-97
Trade Name: CEDAX
Dosage Form: SUSPENSION
Applicant: SCHERING PLOUGH CORP
Active Ingredient(s): CEFTIBUTEN
OTC/RX Status: RX

Application #: 050685 Labeling Supplement #: 003
To Original New Drug Application
Approval Date: 21-MAY-97
Trade Name: CEDAX
Dosage Form: CAPSULE
Applicant: SCHERING PLOUGH CORP
Active Ingredient(s): CEFTIBUTEN
OTC/RX Status: RX

Application #:011719Labeling Supplement#:095
To Original New Drug Application
Approval Date: 20-MAY-97
Trade Name: METHOTREXATE SODIUM
Dosage Form: INJECTABLE
Applicant: LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
Active Ingredient(s): METHOTREXATE SODIUM
OTC/RX Status: RX

Application #:008085Labeling Supplement#:045
To Original New Drug Application
Approval Date: 20-MAY-97
Trade Name: METHOTREXATE SODIUM
Dosage Form: TABLET
Applicant: LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
Active Ingredient(s): METHOTREXATE SODIUM
OTC/RX Status: RX

Application #: 020379 Labeling Supplement #: 007
To Original New Drug Application
Approval Date: 19-MAY-97
Trade Name: CAVERJECT
Dosage Form: INJECTABLE
Applicant: PHARMACIA AND UPJOHN
Active Ingredient(s): ALPROSTADIL
OTC/RX Status: RX

Application #: 020031 Labeling Supplement #: 017
To Original New Drug Application
Approval Date: 19-MAY-97
Trade Name: PAXIL
Dosage Form: TABLET
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): PAROXETINE HYDROCHLORIDE
OTC/RX Status: RX

Application #:019766Labeling Supplement#:018
To Original New Drug Application
Approval Date: 19-MAY-97
Trade Name: ZOCOR
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): SIMVASTATIN
OTC/RX Status: RX

Application #: 019510 Labeling Supplement #: 022
To Original New Drug Application
Approval Date: 16-MAY-97
Trade Name: PEPCID
Dosage Form: INJECTABLE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX

Application #: 019510 Labeling Supplement #: 011
To Original New Drug Application
Approval Date: 16-MAY-97
Trade Name: PEPCID
Dosage Form: INJECTABLE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX

Application #:019463Labeling Supplement#:013
To Original New Drug Application
Approval Date: 16-MAY-97
Trade Name: TIMOPTIC
Dosage Form: SOLUTION/DROPS
Applicant: MERCK AND COMPANY INCORPORATION
Active Ingredient(s): TIMOLOL MALEATE
OTC/RX Status: RX

Application #: 018086 Labeling Supplement #: 047
To Original New Drug Application
Approval Date: 16-MAY-97
Trade Name: TIMOPTIC
Dosage Form: SOLUTION/DROPS
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): TIMOLOL MALEATE
OTC/RX Status: RX

Application #: 050477 Labeling Supplement #: 017
To Original New Drug Application
Approval Date: 13-MAY-97
Trade Name: NEBCIN
Dosage Form: INJECTABLE
Applicant: ELI LILLY AND CO
Active Ingredient(s): TOBRAMYCIN SULFATE
OTC/RX Status: RX

Application #: 019215 Labeling Supplement #: 011
To Original New Drug Application
Approval Date: 13-MAY-97
Trade Name: FEMSTAT
Dosage Form: CREAM
Applicant: SYNTEX LABORATORIES INC SUB SYNTEX CORP
Active Ingredient(s): BUTOCONAZOLE NITRATE
OTC/RX Status: RX

Application #: 018580 Labeling Supplement #: 020
To Original New Drug Application
Approval Date: 13-MAY-97
Trade Name: YUTOPAR
Dosage Form: INJECTABLE
Applicant: ASTRA USA INC
Active Ingredient(s): RITODRINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 050606 Labeling Supplement#: 012 To Original New Drug Application
Approval Date: 12-MAY-97
Trade Name: VANCOCIN HCL
Dosage Form: CAPSULE
Applicant: ELI LILLY AND CO
Active Ingredient(s): VANCOMYCIN HYDROCHLORIDE
OTC/RX Status: RX

Application #: 012122 Labeling Supplement#: 039 To Original New Drug Application
Approval Date: 12-MAY-97
Trade Name: GLUCAGON
Dosage Form: INJECTABLE
Applicant: ELI LILLY AND CO
Active Ingredient(s): GLUCAGON HYDROCHLORIDE
OTC/RX Status: RX

Application #: 017371 Labeling Supplement#: 031 To Original New Drug Application
Approval Date: 06-MAY-97
Trade Name: PRONESTYL
Dosage Form: TABLET
Applicant: APOTHECON INC DIV BRISTOL MYERS SQUIBB
Active Ingredient(s): PROCAINAMIDE HYDROCHLORIDE
OTC/RX Status: RX

Application # :007335 Labeling Supplement#: 061 To Original New Drug Application
Approval Date: 06-MAY-97
Trade Name: PRONESTYL
Dosage Form: CAPSULE; INJECTABLE
Applicant: APOTHECON INC DIV BRISTOL MYERS SQUIBB
Active Ingredient(s): PROCAINAMIDE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020152 Labeling Supplement#: 010 To Original New Drug Application
Approval Date: 05-MAY-97
Trade Name: SERZONE
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): NEFAZODONE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020152 Labeling Supplement#: 009 To Original New Drug Application
Approval Date: 05-MAY-97
Trade Name: SERZONE
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): NEFAZODONE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020500 Labeling Supplement#: 002 To Original New Drug Application
Approval Date: 02-MAY-97
Trade Name: MEPRON
Dosage Form: SUSPENSION
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ATOVAQUONE
OTC/RX Status: RX