Drug Approvals for September 1998

Definitions and Notes

September 1998

Original New Drug Applications

Original Application #: 050744
Approval Date: 30-SEP-98
Trade Name: PERIOSTAT
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: CAPSULE
Applicant: COLLAGENEX INC
Active Ingredient(s): DOXYCYCLINE HYCLATE
OTC/RX Status: RX
Indication(s): To promote attachment level gain and to reduce pocket depth in patients with adult periodontitis

Original Application #: 020892
Approval Date: 25-SEP-98
Trade Name: VALSTAR
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: SOLUTION
Applicant: ANTHRA PHARMACEUTICALS INC
Active Ingredient(s): VALRUBICIN
OTC/RX Status: RX
Indication(s): For intravesical therapy of BCG-refractory carcinoma in situ(CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality

Original Application #: 020801
Approval Date: 24-SEP-98
Trade Name: PEPCID AC
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: TABLET, CHEWABLE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: OTC
Indication(s): For the treatment or prevention of meal-induce heartburn, acid indigestion, and sour stomach

Original Application #: 020927
Approval Date: 22-SEP-98
Trade Name: AREDIA
Chemical Type: 6
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: NOVARTIS PHARMACEUTICALS CORP DBA GEIGY PHARMACEUTICALS DIV
Active Ingredient(s): PAMIDRONATE DISODIUM
OTC/RX Status: RX
Indication(s): For the treatment of osteolytic bone metastases of breast cancer

Original Application #: 020972
Approval Date: 17-SEP-98
Trade Name: SUSTIVA
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: CAPSULE
Applicant: DUPONT MERCK PHARMACEUTICAL CO
Active Ingredient(s): EFAVIRENZ
OTC/RX Status: RX
Indication(s): Treatment of HIV-1 infection

Original Application #: 020887
Approval Date: 14-SEP-98
Trade Name: ACUTECT
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: INJECTABLE
Applicant: DIATIDE INC
Active Ingredient(s): TECHNETIUM TC-99M APCITIDE
OTC/RX Status: RX
Indication(s): For scintigraphic imaging of acute venous thrombosis in the lower extremities of patients who have signs and symptoms of acute venous thrombosis

Original Application #: 020933
Approval Date: 11-SEP-98
Trade Name: VIRAMUNE
Chemical Type:
Therapeutic Potential: P
Dosage Form: SUSPENSION
Applicant: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Active Ingredient(s): NEVIRAPINE
OTC/RX Status: RX
Indication(s): For use in combination therapy with other antiretroviral agents for treatment of HIV-1 infection

Original Application #: 020928
Approval Date: 11-SEP-98
Trade Name: GLUCAGON
Chemical Type: 3
Therapeutic Potential: P
Dosage Form: INJECTABLE
Applicant: ELI LILLY AND CO
Active Ingredient(s): GLUCAGON HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): Treatment of severe hypoglycemia and use as a diagnostic aid in the radiologic examination of the stomach, duodenum, small bowel, and colon when diminished intestinal motility would be advantageous

Original Application #: 020905
Approval Date: 10-SEP-98
Trade Name: ARAVA
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: TABLET
Applicant: HOECHST MARION ROUSSEL INC
Active Ingredient(s): LEFLUNOMIDE
OTC/RX Status: RX
Indication(s): For the treatment of active rheumatoid arthritis (RA) to reduce signs and symptoms and to retard structural damage as evidenced by X-ray erosions and joint space narrowing

Original Application #: 050751
Approval Date: 03-SEP-98
Trade Name: ATRIDOX
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: DRUG DELIVERY SYSTEM
Applicant: ATRIX LABORATORIES INC
Active Ingredient(s): DOXYCYCLINE HYCLATE
OTC/RX Status: RX
Indication(s): For the treatment of chronic adult periodontitis for a gain in clinical attachment, reduction in probing depth, and reduction in bleeding on probing

Original Application #: 020946
Approval Date: 01-SEP-98
Trade Name: PREVEN
Chemical Type: 3
Therapeutic Potential: P
Dosage Form: TABLET
Applicant: GYNETICS INC
Active Ingredient(s): ETHINYL ESTRADIOL; LEVONORGESTREL
OTC/RX Status: RX
Indication(s): For prevention of pregnancy

Efficacy Supplemental New Drug Applications

Application #: 020482 Efficacy Supplement#: 008
Type: SE1 to Original New Drug Application
Approval Date: 29-SEP-98
Trade Name: PRECOSE
Dosage Form: TABLET
Applicant: BAYER CORP
Active Ingredient(s): ACARBOSE
OTC/RX Status: RX
Efficacy Claim: For patients with type 2 diabetes treated with diet plus insulin; and for patients with type 2 diabetes treated with diet plus metformin

Application #: 020692 Efficacy Supplement#: 002
Type: SE5 to Original New Drug Application
Approval Date: 25-SEP-98
Trade Name: SEREVENT DISKUS
Dosage Form: POWDER
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): SALMETEROL XINAFOATE
OTC/RX Status: RX
Efficacy Claim: For the treatment of exercise-induced bronchospasm in adults and children 4 years of age and older with reversible obstructive airway disease

Application #: 019858 Efficacy Supplement#: 018
Type: SE1 to Original New Drug Application
Approval Date: 24-SEP-98
Trade Name: CIPRO IN SODIUM CHLORIDE 0.9%
Dosage Form: INJECTABLE
Applicant: BAYER CORP
Active Ingredient(s): CIPROFLOXACIN
OTC/RX Status: RX
Efficacy Claim: For the treatment of acute sinusitis and chronic bacterial prostatitis infections

Application #: 019857 Efficacy Supplement#: 021
Type: SE1 to Original New Drug Application
Approval Date: 24-SEP-98
Trade Name: CIPRO IN DEXTROSE 5%
Dosage Form: INJECTABLE
Applicant: BAYER CORP
Active Ingredient(s): CIPROFLOXACIN
OTC/RX Status: RX
Efficacy Claim: For the treatment of acute sinusitis and chronic bacterial prostatitis infections

Application #: 019847 Efficacy Supplement#: 018
Type: SE1 to Original New Drug Application
Approval Date: 24-SEP-98
Trade Name: CIPRO
Dosage Form: INJECTABLE
Applicant: BAYER CORP
Active Ingredient(s): CIPROFLOXACIN
OTC/RX Status: RX
Efficacy Claim: For the treatment of acute sinusitis and chronic bacterial prostatitis infections.

Application #: 020503 Efficacy Supplement#: 004
Type: SE1 to Original New Drug Application
Approval Date: 23-SEP-98
Trade Name: PROVENTIL-HFA
Dosage Form: AEROSOL, METERED
Applicant: 3M PHARMACEUTICALS INC
Active Ingredient(s): ALBUTEROL SULFATE
OTC/RX Status: RX
Efficacy Claim: For the prevention of exercise-induced bronchospasm in patients 12 years of age and older

Application #:050662Efficacy Supplement#:020
Type: SE1 to Original New Drug Application
Approval Date: 16-SEP-98
Trade Name: BIAXIN
Dosage Form: TABLET
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): CLARITHROMYCIN
OTC/RX Status: RX
Efficacy Claim: For the use of Biaxin (Clarithromycin) Filmtab Tablets in combination with Prilosec Delayed-Release (omeprazole) Capsules and amoxicillin, as triple therapy for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or one-year history of duodenal ulcer) to eradicate Helicobacter pylori

Application #:020636Efficacy Supplement#:009
Type: SE1 to Original New Drug Application
Approval Date: 11-SEP-98
Trade Name: VIRAMUNE
Dosage Form: TABLET
Applicant: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Active Ingredient(s): NEVIRAPINE
OTC/RX Status: RX
Efficacy Claim: For use in combination therapy with other antiretroviral agents for treatment of HIV-1 infection

Application #:004782Efficacy Supplement#:093
Type: SE2 to Original New Drug Application
Approval Date: 08-SEP-98
Trade Name: PREMARIN
Dosage Form: TABLET
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): ESTROGENS, CONJUGATED
OTC/RX Status: RX
Efficacy Claim: Prevention of osteoporosis

Approvable Original New Drug Applications

Original Application #: 020902
Approvable Date: 30-SEP-98
Trade Name: PEPCID AC
Dosage Form: CAPSULE, COATED, HARD GELATIN
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: OTC

Original Application #: 020850
Approvable Date: 25-SEP-98
Trade Name: MICARDIS
Dosage Form: TABLET
Applicant: BOEHRINGER INGELHEIM
Active Ingredient(s): TELMISARTAN
OTC/RX Status: RX

Original Application #: 020863
Approvable Date: 18-SEP-98
Trade Name: PLETAL
Dosage Form: TABLET
Applicant: OTSUKA AMERICA PHARMACEUTICALS, INC.
Active Ingredient(s): CILOSTAZOL
OTC/RX Status: RX

Original Application #: 020744
Approvable Date: 03-SEP-98
Trade Name: CURASURF
Dosage Form: SUSPENSION
Applicant: DEY LABORATORIES INC
Active Ingredient(s): PORACTANT
OTC/RX Status: RX

Original Application #: 020746
Approvable Date: 02-SEP-98
Trade Name: RHINOCORT AQUA NASAL SPRAY
Dosage Form: SPRAY, METERED
Applicant: ASTRA USA INC
Active Ingredient(s): BUDESONIDE
OTC/RX Status: RX

Original Abbreviated New Drug Applications

Original Abbreviated Application # 075165
Approval Date: 30-SEP-98
Trade Name: RANITIDINE
Dosage Form: TABLET
Applicant: ZENITH GOLDLINE
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075071
Approval Date: 30-SEP-98
Trade Name: ETODOLAC
Dosage Form: CAPSULE
Applicant: GENPHARM INC
Active Ingredient(s): ETODOLAC
OTC/RX Status: RX

Original Abbreviated Application # 075012
Approval Date: 30-SEP-98
Trade Name: ETODOLAC
Dosage Form: TABLET
Applicant: GENPHARM INC
Active Ingredient(s): ETODOLAC
OTC/RX Status: RX

Original Abbreviated Application # 074989
Approval Date: 30-SEP-98
Trade Name: LABETALOL HYDROCHLORIDE
Dosage Form: TABLET
Applicant: TEVA PHARMACEUTICALS USA INC
Active Ingredient(s): LABETALOL HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 074983
Approval Date: 30-SEP-98
Trade Name: ETOPOSIDE
Dosage Form: INJECTABLE
Applicant: APPLIED ANALYTICAL INDUSTRIES INC
Active Ingredient(s): ETOPOSIDE
OTC/RX Status: RX

Original Abbreviated Application # 074980
Approval Date: 30-SEP-98
Trade Name: ACYCLOVIR
Dosage Form: TABLET
Applicant: RANBAXY LABORATORIES LTD
Active Ingredient(s): ACYCLOVIR
OTC/RX Status: RX

Original Abbreviated Application # 074975
Approval Date: 30-SEP-98
Trade Name: ACYCLOVIR
Dosage Form: CAPSULE
Applicant: RANBAXY LABORATORIES LTD
Active Ingredient(s): ACYCLOVIR
OTC/RX Status: RX

Original Abbreviated Application # 074956
Approval Date: 30-SEP-98
Trade Name: DIPYRIDAMOLE
Dosage Form: INJECTABLE
Applicant: AMERICAN PHARMACEUTICAL PARTNERS INC
Active Ingredient(s): DIPYRIDAMOLE
OTC/RX Status: RX

Original Abbreviated Application # 074751
Approval Date: 30-SEP-98
Trade Name: CLOMIPRAMINE HYDROCHLORIDE
Dosage Form: CAPSULE
Applicant: CHELSEA LABORATORIES INC
Active Ingredient(s): CLOMIPRAMINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 074555
Approval Date: 30-SEP-98
Trade Name: CHOLESTYRAMINE (LIGHT)
Dosage Form: SUSPENSION
Applicant: COPLEY PHARMACEUTICAL INC
Active Ingredient(s): CHOLESTYRAMINE
OTC/RX Status: RX

Original Abbreviated Application # 074517
Approval Date: 30-SEP-98
Trade Name: GUANABENZ ACETATE
Dosage Form: TABLET
Applicant: EON LABORATORIES MANUFACTURING INC
Active Ingredient(s): GUANABENZ ACETATE
OTC/RX Status: RX

Original Abbreviated Application # 040281
Approval Date: 30-SEP-98
Trade Name: HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Dosage Form: TABLET
Applicant: ENDO PHARMACEUTICALS INC
Active Ingredient(s): HYDROCODONE BITARTRATE; ACETAMINOPHEN
OTC/RX Status: RX

Original Abbreviated Application # 040280
Approval Date: 30-SEP-98
Trade Name: HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Dosage Form: TABLET
Applicant: ENDO PHARMACEUTICALS INC
Active Ingredient(s): HYDROCODONE BITARTRATE; ACETAMINOPHEN
OTC/RX Status: RX

Original Abbreviated Application # 040279
Approval Date: 30-SEP-98
Trade Name: FLUOROURACIL
Dosage Form: INJECTABLE
Applicant: AMERICAN PHARMACEUTICAL PARTNERS INC
Active Ingredient(s): FLUOROURACIL
OTC/RX Status: RX

Original Abbreviated Application # 040278
Approval Date: 30-SEP-98
Trade Name: FLUOROURACIL
Dosage Form: INJECTABLE
Applicant: AMERICAN PHARMACEUTICAL PARTNERS INC
Active Ingredient(s): FLUOROURACIL
OTC/RX Status: RX

Original Abbreviated Application #: 075167
Tentative Approval Date: 29-SEP-98
Trade Name: RANITIDINE HYDROCHLORIDE
Dosage Form: TABLET
Applicant: TORPHARM INC
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: OTC

Original Abbreviated Application # 075305
Approval Date: 28-SEP-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 # 075211
Approval Date: 28-SEP-98
Trade Name: ACYCLOVIR
Dosage Form: TABLET
Applicant: MYLAN LABORATORIES INC
Active Ingredient(s): ACYCLOVIR
OTC/RX Status: RX

Original Abbreviated Application # 075170
Approval Date: 28-SEP-98
Trade Name: BUTORPHANOL TARTRATE
Dosage Form: INJECTABLE
Applicant: FAULDING PHARMACEUTICAL COMPANY
Active Ingredient(s): BUTORPHANOL TARTRATE
OTC/RX Status: RX

Original Abbreviated Application #: 075140
Tentative Approval Date: 28-SEP-98
Trade Name: TERAZOSIN HYDROCHLORIDE
Dosage Form: CAPSULE
Applicant: MYLAN LABORATORIES INC
Active Ingredient(s): TERAZOSIN HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 074496
Approval Date: 28-SEP-98
Trade Name: LORAZEPAM
Dosage Form: INJECTABLE
Applicant: ELKINS SINN DIV AH ROBINS CO INC
Active Ingredient(s): LORAZEPAM
OTC/RX Status: RX

Original Abbreviated Antibiotic Application # 065002
Approval Date: 28-SEP-98
Trade Name: CEFUROXIME
Dosage Form: INJECTABLE
Applicant: AMERICAN PHARMACEUTICAL PARTNERS INC
Active Ingredient(s): CEFUROXIME
OTC/RX Status: RX

Original Abbreviated Application # 040302
Approval Date: 28-SEP-98
Trade Name: LIDOCAINE HYDROCHLORIDE
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): LIDOCAINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 040026
Approval Date: 25-SEP-98
Trade Name: PROMETHAZINE HCL
Dosage Form: SYRUP
Applicant: HI TECH PHARMACAL CO INC
Active Ingredient(s): PROMETHAZINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075041
Approval Date: 22-SEP-98
Trade Name: ISOSORBIDE MONONITRATE
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: ELAN PHARMACEUTICAL RESEARCH CORP
Active Ingredient(s): ISOSORBIDE MONONITRATE
OTC/RX Status: RX

Original Abbreviated Application # 075107
Approval Date: 04-SEP-98
Trade Name: PENTOXIFYLLINE
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: WATSON LABORATORIES
Active Ingredient(s): PENTOXIFYLLINE
OTC/RX Status: RX

Original Abbreviated Application # 074759
Approval Date: 02-SEP-98
Trade Name: AMINOCAPROIC ACID
Dosage Form: SYRUP
Applicant: MIKART INC
Active Ingredient(s): AMINOCAPROIC ACID
OTC/RX Status: RX

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

Labeling Supplements to Original New Drug Applications

Application #: 011178 Labeling Supplement #: 037
To Original New Drug Application
Approval Date: 30-SEP-98
Trade Name: ISUPREL
Dosage Form: AEROSOL, METERED
Applicant: SANOFI PHARMACEUTICALS INC
Active Ingredient(s): ISOPROTERENOL HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020235 Labeling Supplement #: 011
To Original New Drug Application
Approval Date: 29-SEP-98
Trade Name: NEURONTIN
Dosage Form: CAPSULE
Applicant: PARKE-DAVID PHARMACEUTICAL RESEARCH
Active Ingredient(s): GABAPENTIN
OTC/RX Status: RX

Application #: 019858 Labeling Supplement#: 017
To Original New Drug Application
Approval Date: 24-SEP-98
Trade Name: CIPRO IN SODIUM CHLORIDE 0.9%
Dosage Form: INJECTIONABLE
Applicant: BAYER CORP
Active Ingredient(s): CIPROFLOXACIN
OTC/RX Status: RX

Application #: 019857 Labeling Supplement#: 024
To Original New Drug Application
Approval Date: 24-SEP-98
Trade Name: CIPRO IN DEXTROSE 5%
Dosage Form: INJECTABLE
Applicant: BAYER CORP
Active Ingredient(s): CIPROFLOXACIN
OTC/RX Status: RX

Application #: 019857 Labeling Supplement#: 020
To Original New Drug Application
Approval Date: 24-SEP-98
Trade Name: CIPRO IN DEXTROSE 5%
Dosage Form: INJECTABLE
Applicant: BAYER CORP
Active Ingredient(s): CIPROFLOXACIN
OTC/RX Status: RX

Application #: 019847 Labeling Supplement#: 020
To Original New Drug Application
Approval Date: 24-SEP-98
Trade Name: CIPRO
Dosage Form: INJECTABLE
Applicant: BAYER CORP
Active Ingredient(s): CIPROFLOXACIN
OTC/RX Status: RX

Application #: 019847 Labeling Supplement#: 017
To Original New Drug Application
Approval Date: 24-SEP-98
Trade Name: CIPRO
Dosage Form: INJECTABLE
Applicant: BAYER CORP
Active Ingredient(s): CIPROFLOXACIN
OTC/RX Status: RX

Application #: 019545 Labeling Supplement#: 005
To Original New Drug Application
Approval Date: 22-SEP-98
Trade Name: DIDRONEL
Dosage Form: INJECTABLE
Applicant: MGI PHARMA INC
Active Ingredient(s): ETIDRONATE DISODIUM
OTC/RX Status: RX

Application #: 019735 Labeling Supplement#: 044
To Original New Drug Application
Approval Date: 21-SEP-98
Trade Name: FLOXIN
Dosage Form: TABLET
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP
Active Ingredient(s): OFLOXACIN
OTC/RX Status: RX

Application #: 050522 Labeling Supplement#: 019
To Original New Drug Application
Approval Date: 18-SEP-98
Trade Name: CECLOR
Dosage Form: SUSPENSION
Applicant: ELI LILLY AND CO
Active Ingredient(s): CEFACLOR
OTC/RX Status: RX

Application #: 050521 Labeling Supplement#: 022
To Original New Drug Application
Approval Date: 18-SEP-98
Trade Name: CECLOR
Dosage Form: CAPSULE
Applicant: ELI LILLY AND CO
Active Ingredient(s): CEFACLOR
OTC/RX Status: RX

Application #: 018461 Labeling Supplement#: 046
To Original New Drug Application
Approval Date: 18-SEP-98
Trade Name: LIDOCAINE HCL 0.1%, 0.2%, AND 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER
Dosage Form: INJECTABLE
Applicant: BAXTER HEALTHCARE CORP
Active Ingredient(s): LIDOCAINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020413 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 16-SEP-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#: 011
To Original New Drug Application
Approval Date: 16-SEP-98
Trade Name: ZERIT
Dosage Form: CAPSULE
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): STAVUDINE
OTC/RX Status: RX

Application #: 018039 Labeling Supplement#: 023
To Original New Drug Application
Approval Date: 16-SEP-98
Trade Name: LOXITANE IM
Dosage Form: INJECTABLE
Applicant: WATSON LABORATORIES INC
Active Ingredient(s): LOXAPINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 017658 Labeling Supplement#: 035
To Original New Drug Application
Approval Date: 16-SEP-98
Trade Name: LOXITANE C
Dosage Form: CONCENTRATE
Applicant: WATSON LABORATORIES INC
Active Ingredient(s): LOXAPINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 017525 Labeling Supplement#: 049
To Original New Drug Application
Approval Date: 16-SEP-98
Trade Name: LOXITANE
Dosage Form: CAPSULE
Applicant: WATSON LABORATORIES INC
Active Ingredient(s): LOXAPINE SUCCINATE
OTC/RX Status: RX

Application #: 005264 Labeling Supplement#: 070
To Original New Drug Application
Approval Date: 16-SEP-98
Trade Name: HEPARIN LOCK FLUSH
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES HOSP PRODUCTS DIV
Active Ingredient(s): HEPARIN SODIUM
OTC/RX Status: RX

Application #: 050753 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 11-SEP-98
Trade Name: TOBI
Dosage Form: SOLUTION
Applicant: PATHOGENESIS CORP
Active Ingredient(s): TOBRAMYCIN
OTC/RX Status: RX

Application #: 020718 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 11-SEP-98
Trade Name: INTEGRILIN
Dosage Form: INJECTABLE
Applicant: COR THERAPEUTICS INC
Active Ingredient(s): EPTIFIBATIDE
OTC/RX Status: RX

Application #: 020474 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 11-SEP-98
Trade Name: VEXOL
Dosage Form: SUSPENSION
Applicant: ALCON LABORATORIES INC
Active Ingredient(s): RIMEXOLONE
OTC/RX Status: RX

Application #: 02047 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 04-SEP-98
Trade Name: ZYFLO
Dosage Form: TABLET
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): ZILEUTON
OTC/RX Status: RX