Drug Approvals for January 1998

Definitions and Notes

January 1998

Original New Drug Applications

Original Application #: 050731
Approval Date: 30-JAN-98
Trade Name: DAUNORUBICIN HCL
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
Active Ingredient(s): DAUNORUBICIN HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): Indicated (in combination with other approved anticancer drugs) for remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) of adults and for remission induction in acute lymphocytic leukemia of children and adults

Original Application #: 020812
Approval Date: 30-JAN-98
Trade Name: PEDIATRIC ADVIL
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: SUSPENSION/DROPS
Applicant: WHITEHALL ROBINS HEALTHCARE
Active Ingredient(s): IBUPROFEN
OTC/RX Status: OTC
Indication(s): For the temporary reduction of fever and the temporary relief of minor aches and pains due to colds, flu, sore throat, headaches and toothaches

Original Application #: 020697
Approval Date: 29-JAN-98
Trade Name: TASMAR
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: HOFFMANN LA ROCHE INC
Active Ingredient(s): TOLCAPONE
OTC/RX Status: RX
Indication(s): As an adjunct to levodopa and carbidopa for the treatment of the signs and symptoms of idiopathic Parkinson's disease

Original Application #: 020400
Approval Date: 29-JAN-98
Trade Name: AVITA
Chemical Type: 5
Therapeutic Potential: S
Dosage Form: GEL
Applicant: PENEDERM INC
Active Ingredient(s): TRETINOIN
OTC/RX Status: RX
Indication(s): Treatment of acne vulgaris

Original Application #: 020802
Approval Date: 14-JAN-98
Trade Name: EXCEDRIN MIGRAINE
Chemical Type: 7
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: BRISTOL MYERS PRODUCTS
Active Ingredient(s): ACETAMINOPHEN; ASPIRIN; CAFFEINE
OTC/RX Status: OTC
Indication(s): For the temporary relief of mild to moderate pain associated with migraine headache

Original Application #: 020802
Approval Date: 14-JAN-98
Trade Name: EXCEDRIN MIGRAINE
Chemical Type: 7
Therapeutic Potential: S
Dosage Form: CAPLETS
Applicant: BRISTOL MYERS PRODUCTS
Active Ingredient(s): ACETAMINOPHEN; ASPIRIN; CAFFEINE
OTC/RX Status: OTC
Indication(s): For the temporary relief of mild to moderate pain associated with migraine headache

Original Application #: 020802
Approval Date: 14-JAN-98
Trade Name: EXCEDRIN MIGRAINE
Chemical Type: 7
Therapeutic Potential: S
Dosage Form: GELTABS
Applicant: BRISTOL MYERS PRODUCTS
Active Ingredient(s): ACETAMINOPHEN; ASPIRIN; CAFFEINE
OTC/RX Status: OTC
Indication(s): For the temporary relief of mild to moderate pain associated with migraine headache

Original Application #: 020181
Approval Date: 13-JAN-98
Trade Name: LIPOSYN III 30%
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: BULK
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): EGG YOLK PHOSPHATIDES; GLYCERIN; SOYBEAN OIL
OTC/RX Status: RX
Indication(s): As a source of calories for patients requiring parenteral nutrition and of essential fatty acids for extended parenteral nutrition

Efficacy Supplemental New Drug Applications

Application #: 050679 Efficacy Supplement#: 008
Type: SE1 to Original New Drug Application
Approval Date: 30-JAN-98
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: Provides for the additional use of Maxipime in combination with metronidazole for the treatment of Complicated Intra-abdominal Infections

Application #: 020401 Efficacy Supplement#: 007
Type: SE1 to Original New Drug Application
Approval Date: 30-JAN-98
Trade Name: TIAZAC
Dosage Form: CAPSULE, EXTENDED RELEASE
Applicant: BIOVAIL LABORATORIES INC
Active Ingredient(s): DILTIAZEM HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim: Treatment of chronic stable angina

Application #: 020164 Efficacy Supplement#: 010
Type: SE1 to Original New Drug Application
Approval Date: 30-JAN-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 prevention (during and following hospitalization) of deep vein thrombosis, which may lead to pulmonary embolism, in patient undergoing hip replacement surgery

Application #: 011559 Efficacy Supplement#: 029
Type: SE3 to Original New Drug Application
Approval Date: 30-JAN-98
Trade Name: BREVITAL SODIUM
Dosage Form: INJECTABLE
Applicant: ELI LILLY AND CO
Active Ingredient(s): METHOHEXITAL SODIUM
OTC/RX Status: RX
Efficacy Claim: For rectal use in pediatric patients

Application #:020527 Efficacy Supplement#: 006
Type: SE2 to Original New Drug Application
Approval Date: 09-JAN-98
Trade Name: PREMPRO
Dosage Form: TABLET
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE
OTC/RX Status: RX
Efficacy Claim: Treatment of moderate to severe vasomotor symptoms associated with the menopause; treatment of vulvar and vaginal atrophy; prevention of osteoporosis

Application #:020451Efficacy Supplement#: 002
Type: SE1 to Original New Drug Application
Approval Date: 09-JAN-98
Trade Name: PHOTOFRIN
Dosage Form: INJECTABLE
Applicant: QLT PHOTOTHERAPEUTICS INC SUB LEDERLE LABORATORIES
Active Ingredient(s): PORFIMER SODIUM
OTC/RX Status: RX
Efficacy Claim: For use in photodynamic therapy for treatment of microinvasive endobronchial nonsmall cell lung cancer in patients for whom surgery and radiotherapy are not indicated

Application #:050671 Efficacy Supplement#: 002
Type: SE5 to Original New Drug Application
Approval Date: 08-JAN-98
Trade Name: VANCOCIN HCL
Dosage Form: INJECTABLE
Applicant: BAXTER HEALTHCARE CORPORATION
Active Ingredient(s): VANCOMYCIN HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim: Provides for specific dosing of premature neonates

Approvable Original New Drug Applications

Original Application #: 020809
Approvable Date: 05-JAN-98
Trade Name: DICLOFENAC SODIUM
Dosage Form: SOLUTION/DROPS
Applicant: ALCON LABORATORIES INC
Active Ingredient(s): DICLOFENAC SODIUM
OTC/RX Status: RX

Original Abbreviated New Drug Applications

Original Abbreviated Application # 075000
Approval Date: 30-JAN-98
Trade Name: RANITIDINE
Dosage Form: TABLET
Applicant: RANBAXY PHARMACEUTICALS INC
Active Ingredient(s): RANITIDINE
OTC/RX Status: RX

Original Abbreviated Application # 074929
Approval Date: 30-JAN-98
Trade Name: ETODOLAC
Dosage Form: CAPSULE
Applicant: AESGEN INC
Active Ingredient(s): ETODOLAC
OTC/RX Status: RX

Original Abbreviated Application # 074811
Approval Date: 30-JAN-98
Trade Name: HALOPERIDOL DECANOATE
Dosage Form: INJECTABLE
Applicant: BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
Active Ingredient(s): HALOPERIDOL DECANOATE
OTC/RX Status: RX

Original Abbreviated Application # 074749
Approval Date: 30-JAN-98
Trade Name: ALBUTEROL SULFATE
Dosage Form: SYRUP
Applicant: HI-TECH PHARMACAL CO., INC.
Active Ingredient(s): ALBUTEROL SULFATE
OTC/RX Status: RX

Original Abbreviated Application # 040138
Approval Date: 30-JAN-98
Trade Name: ESTRADIOL
Dosage Form: TABLET
Applicant: ENDEAVOR PHARMACEUTICALS INC
Active Ingredient(s): ESTRADIOL
OTC/RX Status: RX

Original Abbreviated Application # 074806
Approval Date: 23-JAN-98
Trade Name: PERMETHRIN
Dosage Form: CREAM
Applicant: ALPHARMA, U.S. PHARMACEUTICALS DIVISION
Active Ingredient(s): PERMETHRIN
OTC/RX Status: RX

Original Abbreviated Application # 040219
Approval Date: 22-JAN-98
Trade Name: OXYCODONE AND ACETAMINOPHEN
Dosage Form: CAPSULE
Applicant: HALSEY DRUG CO INC
Active Ingredient(s): ACETAMINOPHEN; OXYCODONE
OTC/RX Status: RX

Original Abbreviated Application # 074815
Approval Date: 20-JAN-98
Trade Name: ALPROSTADIL
Dosage Form: INJECTABLE
Applicant: BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
Active Ingredient(s): ALPROSTADIL
OTC/RX Status: RX

Original Abbreviated Application # 040162
Approval Date: 20-JAN-98
Trade Name: PROCHLORPERAZINE MALEATE
Dosage Form: TABLET
Applicant: ZENITH LABORATORIES INC
Active Ingredient(s): PROCHLORPERAZINE MALEATE
OTC/RX Status: RX

Original Abbreviated Application # 074543
Approval Date: 15-JAN-98
Trade Name: ALBUTEROL SULFATE
Dosage Form: SOLUTION
Applicant: HI TECH PHARMACAL CO INC
Active Ingredient(s): ALBUTEROL SULFATE
OTC/RX Status: RX

Original Abbreviated Application # 074631
Approval Date: 13-JAN-98
Trade Name: BROMOCRIPTINE MESYLATE
Dosage Form: TABLET
Applicant: LEK PHARMACEUTICAL AND CHEMICAL CO DD
Active Ingredient(s): BROMOCRIPTINE MESYLATE
OTC/RX Status: RX

Original Abbreviated Application # 074968
Approval Date: 09-JAN-98
Trade Name: ETOPOSIDE
Dosage Form: INJECTABLE
Applicant: MARSAM PHARMACEUTICALS INC
Active Ingredient(s): ETOPOSIDE
OTC/RX Status: RX

Original Abbreviated Application # 074970
Approval Date: 06-JAN-98
Trade Name: TRIAMTERENE AND HYDROCHLOROTHIAZIDE
Dosage Form: CAPSULE
Applicant: BARR LABORATORIES INC
Active Ingredient(s): HYDROCHLOROTHIAZIDE; TRIAMTERENE
OTC/RX Status: RX

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

Original Abbreviated Application #: 074978
Tentative Approval Date: 30-JAN-98
Trade Name: IBUPROFEN
Dosage Form: SUSPENSION
Applicant: ALPHARMA USPD INC
Active Ingredient(s): IBUPROFEN
OTC/RX Status: RX

Original Abbreviated Application #: 074916
Tentative Approval Date: 09-JAN-98
Trade Name: IBUPROFEN
Dosage Form: SUSPENSION
Applicant: ALPHARMA USPD INC
Active Ingredient(s): IBUPROFEN
OTC/RX Status: OTC

Labeling Supplements to Original New Drug Applications

Application #: 020430 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 30-JAN-98
Trade Name: ORGARAN
Dosage Form: INJECTABLE
Applicant: ORGANON INC SUB AKZONA INC
Active Ingredient(s): DANAPAROID SODIUM
OTC/RX Status: RX

Application #: 020287 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 30-JAN-98
Trade Name: FRAGMIN
Dosage Form: INJECTABLE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): DALTEPARIN SODIUM
OTC/RX Status: RX

Application #: 020227 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 30-JAN-98
Trade Name: NORMIFLO
Dosage Form: INJECTABLE
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): ARDEPARIN SODIUM
OTC/RX Status: RX

Application #: 019660 Labeling Supplement#: 016
To Original New Drug Application
Approval Date: 30-JAN-98
Trade Name: TILADE
Dosage Form: AEROSOL, METERED
Applicant: RHONE POULENC RORER CENTRAL RESEARCH
Active Ingredient(s): NEDOCROMIL SODIUM
OTC/RX Status: RX

Application #: 018238 Labeling Supplement#: 023
To Original New Drug Application
Approval Date: 30-JAN-98
Trade Name: MICRO-K
Dosage Form: CAPSULE, EXTENDED RELEASE
Applicant: AH ROBINS CO
Active Ingredient(s): POTASSIUM CHLORIDE
OTC/RX Status: RX

Application #: 018238 Labeling Supplement#: 022
To Original New Drug Application
Approval Date: 30-JAN-98
Trade Name: MICRO-K
Dosage Form: CAPSULE, EXTENDED RELEASE
Applicant: AH ROBINS CO
Active Ingredient(s): POTASSIUM CHLORIDE
OTC/RX Status: RX

Application #: 005929 Labeling Supplement#: 025
To Original New Drug Application
Approval Date: 29-JAN-98
Trade Name: D.H.E. 45
Dosage Form: INJECTABLE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): DIHYDROERGOTAMINE MESYLATE
OTC/RX Status: RX

Application #: 005929 Labeling Supplement#: 019
To Original New Drug Application
Approval Date: 29-JAN-98
Trade Name: D.H.E. 45
Dosage Form: INJECTABLE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): DIHYDROERGOTAMINE MESYLATE
OTC/RX Status: RX

Application #: 020560 Labeling Supplement#: 010
To Original New Drug Application
Approval Date: 27-JAN-98
Trade Name: FOSAMAX
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES
Active Ingredient(s): ALENDRONATE SODIUM
OTC/RX Status: RX

Application #: 020280 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 27-JAN-98
Trade Name: GENOTROPIN
Dosage Form: INJECTABLE
Applicant: PHARMACIA AND UPJOHN COMPANY
Active Ingredient(s): SOMATROPIN, BIOSYNTHETIC
OTC/RX Status: RX

Application #: 050646 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 26-JAN-98
Trade Name: CEPTAZ
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): CEFTAZIDIME (ARGININE FORMULATION)
OTC/RX Status: RX

Application #:050634Labeling Supplement#:006
To Original New Drug Application
Approval Date: 26-JAN-98
Trade Name: FORTAZ IN PLASTIC CONTAINER
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): CEFTAZIDIME SODIUM
OTC/RX Status: RX

Application #: 050578 Labeling Supplement#: 032
To Original New Drug Application
Approval Date: 26-JAN-98
Trade Name: FORTAZ
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): CEFTAZIDIME
OTC/RX Status: RX

Application #: 019833 Labeling Supplement#: 011
To Original New Drug Application
Approval Date: 26-JAN-98
Trade Name: ADVIL
Dosage Form: SUSPENSION
Applicant: AMERICAN HOME PRODUCTS CORP
Active Ingredient(s): IBUPROFEN
OTC/RX Status: RX

Application #: 019981 Labeling Supplement#: 003
To Original New Drug Application
Approval Date: 23-JAN-98
Trade Name: ULTRATAG RBC
Dosage Form: INJECTABLE
Applicant: MALLINCKRODT MEDICAL INC
Active Ingredient(s): TECHNETIUM Tc 99M-Labeled Red Blood Cells
OTC/RX Status: RX

Application #: 018671 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 23-JAN-98
Trade Name: SODIUM IODIDE I-123
Dosage Form: INJECTABLE
Applicant: SYNCOR PHARMACEUTICALS, INC
Active Ingredient(s): SODIUM IODIDE I-123
OTC/RX Status: RX

Application #: 017055 Labeling Supplement#: 012
To Original New Drug Application
Approval Date: 23-JAN-98
Trade Name: A.P.L.
Dosage Form: INJECTABLE
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): GONADOTROPIN, CHORIONIC
OTC/RX Status: RX

Application #: 020729 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 21-JAN-98
Trade Name: UNIRETIC
Dosage Form: TABLET
Applicant: SCHWARZ PHARMA INC
Active Ingredient(s): HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE
OTC/RX Status: RX

Application #: 019157 Labeling Supplement#: 016
To Original New Drug Application
Approval Date: 21-JAN-98
Trade Name: PEDIAPRED
Dosage Form: SOLUTION
Applicant: MEDEVA PHARMACEUTICALS INC
Active Ingredient(s): PREDNISOLONE SODIUM PHOSPHATE
OTC/RX Status: RX

Application #: 020628 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 16-JAN-98
Trade Name: INVIRASE
Dosage Form: CAPSULE
Applicant: HOFFMANN LA ROCHE INC
Active Ingredient(s): SAQUINAVIR MESYLATE
OTC/RX Status: RX

Application #:020604 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 16-JAN-98
Trade Name: SEROSTIM
Dosage Form: INJECTABLE
Applicant: SERONO LABORATORIES INC
Active Ingredient(s): SOMATROPIN, BIOSYNTHETIC
OTC/RX Status: RX

Application #: 017876 Labeling Supplement#: 027
To Original New Drug Application
Approval Date: 16-JAN-98
Trade Name: LOESTRIN 21 1/20
Dosage Form: TABLET
Applicant: PARKE DAVIS PHARMACEUTICALS RES
Active Ingredient(s): ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
OTC/RX Status: RX

Application #: 017875 Labeling Supplement#: 028
To Original New Drug Application
Approval Date: 16-JAN-98
Trade Name: LOESTRIN 21 1.5/30
Dosage Form: TABLET
Applicant: PARKE DAVIS PHARMACEUTICALS RES
Active Ingredient(s): ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
OTC/RX Status: RX

Application #: 017355 Labeling Supplement#: 042
To Original New Drug Application
Approval Date: 16-JAN-98
Trade Name: LOESTRIN FE 1.5/30
Dosage Form: TABLET
Applicant: PARKE DAVIS PHARMACEUTICALS RES
Active Ingredient(s): ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
OTC/RX Status: RX

Application #: 017354 Labeling Supplement#: 040
To Original New Drug Application
Approval Date: 16-JAN-98
Trade Name: LOESTRIN FE 1/20
Dosage Form: TABLET
Applicant: PARKE DAVIS PHARMACEUTICALS RES
Active Ingredient(s): ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
OTC/RX Status: RX

Application #:017352 Labeling Supplement#: 018
To Original New Drug Application
Approval Date: 16-JAN-98
Trade Name: FASTIN
Dosage Form: CAPSULE
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 019906 Labeling Supplement#: 020
To Original New Drug Application
Approval Date: 15-JAN-98
Trade Name: ANAFRANIL
Dosage Form: CAPSULE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): CLOMIPRAMINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020552 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 13-JAN-98
Trade Name: COVERA-HS
Dosage Form: TABLET
Applicant: GD SEARLE AND CO
Active Ingredient(s): VERAPAMIL HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020313 Labeling Supplement#: 010
To Original New Drug Application
Approval Date: 12-JAN-98
Trade Name: MIACALCIN
Dosage Form: SPRAY
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): CALCITONIN BIOSYNTHETIC SALMON
OTC/RX Status: RX

Application #: 019834 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 13-JAN-98
Trade Name: PLENDIL
Dosage Form: TABLET
Applicant: ASTRA MERCK INC
Active Ingredient(s): FELODIPINE
OTC/RX Status: RX

Application #: 019152 Labeling Supplement#: 023
To Original New Drug Application
Approval Date: 13-JAN-98
Trade Name: ISOPTIN SR
Dosage Form: TABLET
Applicant: KNOLL PHARMACEUTICAL CO SUB BASF CORP
Active Ingredient(s): VERAPAMIL HYDROCHLORIDE
OTC/RX Status: RX

Application #: 018817 Labeling Supplement#: 019
To Original New Drug Application
Approval Date: 13-JAN-98
Trade Name: CALAN
Dosage Form: TABLET
Applicant: GD SEARLE AND CO
Active Ingredient(s): VERAPAMIL HYDROCHLORIDE
OTC/RX Status: RX

Application #:020451Labeling Supplement#:002
To Original New Drug Application
Approval Date: 09-JAN-98
Trade Name: PHOTOFRIN
Dosage Form: INJECTABLE
Applicant: QLT PHOTOTHERAPEUTICS INC
Active Ingredient(s): PORFIMER SODIUM
OTC/RX Status: RX

Application #: 020130 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 09-JAN-98
Trade Name: ESTROSTEP 21
Dosage Form: TABLET
Applicant: PARKE DAVIS PHARMACEUTICAL RESEARCH DIV WARNER LAMBERT CO
Active Ingredient(s): ETHINYL ESTRADIOL; NORETHINDRONE ACETATE;
OTC/RX Status: RX

Application #: 019732 Labeling Supplement#: 012
To Original New Drug Application
Approval Date: 09-JAN-98
Trade Name: LUPRON DEPOT
Dosage Form: INJECTABLE
Applicant: TAP HOLDINGS INC
Active Ingredient(s): LEUPROLIDE ACETATE
OTC/RX Status: RX

Application #: 012122 Labeling Supplement#: 041
To Original New Drug Application
Approval Date: 08-JAN-98
Trade Name: GLUCAGON
Dosage Form: INJECTABLE
Applicant: ELI LILLY AND COMPANY
Active Ingredient(s): GLUCAGON HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020449 Labeling Supplement #: 004
To Original New Drug Application
Approval Date: 06-JAN-98
Trade Name: TAXOTERE
Dosage Form: INJECTABLE
Applicant: RHONE POULENC PHARMACEUTICALS DIV RHONE POULENC INC
Active Ingredient(s): DOCETAXEL
OTC/RX Status: RX

Application #: 020388 Labeling Supplement #: 005
To Original New Drug Application
Approval Date: 06-JAN-98
Trade Name: NAVELBINE
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): VINORELBINE TARTRATE
OTC/RX Status: RX

Application #: 019880 Labeling Supplement #: 009
To Original New Drug Application
Approval Date: 06-JAN-98
Trade Name: PARAPLATIN
Dosage Form: INJECTABLE
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): CARBOPLATIN
OTC/RX Status: RX

Application #: 018841 Labeling Supplement#: 015
To Original New Drug Application
Approval Date: 06-JAN-98
Trade Name: DAYPRO
Dosage Form: TABLET
Applicant: GD SEARLE AND CO
Active Ingredient(s): OXAPROZIN
OTC/RX Status: RX

Application #: 018841 Labeling Supplement#: 014
To Original New Drug Application
Approval Date: 06-JAN-98
Trade Name: DAYPRO
Dosage Form: TABLET
Applicant: GD SEARLE AND CO
Active Ingredient(s): OXAPROZIN
OTC/RX Status: RX

Application #: 018841 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 06-JAN-98
Trade Name: DAYPRO
Dosage Form: TABLET
Applicant: GD SEARLE AND CO
Active Ingredient(s): OXAPROZIN
OTC/RX Status: RX

Application #: 018841 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 06-JAN-98
Trade Name: DAYPRO
Dosage Form: TABLET
Applicant: GD SEARLE AND CO
Active Ingredient(s): OXAPROZIN
OTC/RX Status: RX

Application #: 020280 Labeling Supplement#: 010
To Original New Drug Application
Approval Date: 05-JAN-98
Trade Name: GENOTROPIN
Dosage Form: INJECTABLE
Applicant: PHARMACIA AND UPJOHN COMPANY
Active Ingredient(s): SOMATROPIN, BIOSYNTHETIC
OTC/RX Status: RX