Drug Approvals for February 2001

Definitions and Notes

Original New Drug Applications

Original Application #: 021169
Approval Date: 28-FEB-01
Trade Name: REMINYL
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: JANSSEN RESEARCH FDN
Active Ingredient(s): GALANTAMINE HYDROBROMIDE
OTC/RX Status: RX
Indication(s): For the treatment of mild to moderate dementia of the Alzheimer's type

Original Application #: 021015
Approval Date: 28-FEB-00
Trade Name: ANDROGEL
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: GEL
Applicant: UNIMED PHARMACEUTICALS INC
Active Ingredient(s): TESTOSTERONE
OTC/RX Status: RX
Indication(s): For replacement therapy in males for conditions associated with a deficiency of absence of endogenous testosterone

Original Application #: 021235
Approval Date: 26-FEB-01
Trade Name: PROZAC
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: CAPSULE
Applicant: ELI LILLY AND CO
Active Ingredient(s): FLUOXETINE HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): For the treatment of depression

Original Application #: 050780
Approval Date: 21-FEB-01
Trade Name: CEFUROXIME
Chemical Type: 5
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: B BRAUN MEDICAL INC
Active Ingredient(s): CEFUROXIME SODIUM
OTC/RX Status: RX
Indication(s): For the treatment of lower respiratory tract infections, urinary tract infections, skin and skin structure infections, septicemia, meningitis, gonorrhea, and bone and joint infections

Original Application #: 021154
Approval Date: 20-FEB-01
Trade Name: NEXIUM
Chemical Type: 2
Therapeutic Potential: S
Dosage Form: CAPSULE
Applicant: ASTRAZENECA LP
Active Ingredient(s): ESOMEPRAZOLE MAGNESIUM
OTC/RX Status: RX
Indication(s): In combination with clarithromycin and amoxicillin for the eradication of Helicobacter pylori in patients with duodenal ulcer disease or a history of duodenal ulcer disease

Original Application #: 021153
Approval Date: 20-FEB-01
Trade Name: NEXIUM
Chemical Type: 2
Therapeutic Potential: S
Dosage Form: CAPSULE
Applicant: ASTRAZENECA LP
Active Ingredient(s): ESOMEPRAZOLE MAGNESIUM
OTC/RX Status: RX
Indication(s): Healing of erosive esophagitis; maintenance of healing of erosive esophagitis; treatment of symptomatic gastroesophageal reflux disease

Original Application #: 050781
Approval Date: 16-FEB-01
Trade Name: ARESTIN
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: DOSAGE FORM NOT GIVEN
Applicant: ORAPHARMA INC
Active Ingredient(s): MINOCYCLINE
OTC/RX Status: RX
Indication(s): As an adjunct to scaling and root planning procedures for reduction or pocket depth in patients with adult periodontitis

Original Application #: 020831
Approval Date: 16-FEB-01
Trade Name: FORADIL
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: POWDER, FOR INHALATION
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): FORMOTEROL FUMARATE
OTC/RX Status: RX
Indication(s): For long-term, twice daily (morning and evening) administration in the maintenance treatment of asthma and in the prevention bronchospasm in adults and children 5 years of age and older with reversible obstructive airway disease, including patients with symptoms of nocturnal asthma, who require regular treatment with inhaled, short-acting, beta2-agonists

Original Application #: 021231
Approval Date: 13-FEB-01
Trade Name: ZOMIG-ZMT
Chemical Type:
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: ASTRAZENECA PHARMACEUTICALS LP
Active Ingredient(s): ZOLMITRIPTAN
OTC/RX Status: RX
Indication(s): For acute treatment of migraine

Original Application #: 020825
Approval Date: 05-FEB-01
Trade Name: ZIPRASIDONE
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: CAPSULE
Applicant: PFIZER MEDICINAL PRODUCT RESEARCH AND DEVELOPMENT
Active Ingredient(s): ZIPRASIDONE HYDROCHLORIDE
OTC/RX Status: RX
Indication(s):For the treatment of schizophrenia

Original Application #: 050783
Approval Date: 02-FEB-01
Trade Name: PERIOSTAT
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: COLLAGENEX PHARMACEUTICALS INC
Active Ingredient(s): DOXYCYCLINE HYCLATE
OTC/RX Status: RX
Indication(s):As an adjunct to scaling and root planting to promote attachment level gain and to reduce pocket depth in patients with adult periodontitis

Original Application #: 021261
Approval Date: 02-FEB-01
Trade Name: MONISTAT 3
Chemical Type:
Therapeutic Potential: S
Dosage Form: EMULSION, CREAM
Applicant: PERSONAL PRODUCTS CO
Active Ingredient(s): MICONAZOLE NITRATE
OTC/RX Status: OTC
Indication(s): For the treatment of vaginal yeast infections and the relief of external itching and irritation due to a vaginal yeast infection

Efficacy Supplemental New Drug Applications

Application #:019962Efficacy Supplement#:013
Type: SE1 to Original New Drug Application
Approval Date: 05-FEB-01
Trade Name: TOPROL-XL
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: ASTRAZENECA LP
Active Ingredient(s): METOPROLOL SUCCINATE
OTC/RX Status: RX
Efficacy Claim: For the treatment of congestive heart failure and for a 25mg dosage strength scored tablet.

Approvable Original New Drug Applications

Original Abbreviated New Drug Applications

Original Abbreviated Application # 075402
Approval Date: 28-FEB-01
Trade Name: METAPROTERENOL SULFATE
Dosage Form: SOLUTION
Applicant: NOVEX PHARMA
Active Ingredient(s): METAPROTERENOL SULFATE
OTC/RX Status: RX

Original Abbreviated Application # 075403
Approval Date: 28-FEB-01
Trade Name: METAPROTERENOL SULFATE
Dosage Form: SOLUTION
Applicant: NOVEX PHARMA
Active Ingredient(s): METAPROTERENOL SULFATE
OTC/RX Status: RX

Original Abbreviated Application # 075847
Approval Date: 28-FEB-01
Trade Name: OXAPROZIN
Dosage Form: TABLET
Applicant: GENPHARM INC
Active Ingredient(s): OXAPROZIN
OTC/RX Status: RX

Original Abbreviated Application # 040396
Approval Date: 27-FEB-01
Trade Name: MICORT-HC-LIPOCREAM
Dosage Form: CREAM
Applicant: FERNDALE LABORATORIES, INC
Active Ingredient(s): HYDROCORTISONE ACETATE
OTC/RX Status: RX

Original Abbreviated Antibiotic Application# 065068
Approval Date: 26-FEB-01
Trade Name: PENICILLIN G SODIUM
Dosage Form: INJECTABLE
Applicant: BIOCHEMIE GMBH
Active Ingredient(s): PENICILLIN G SODIUM
OTC/RX Status: RX

Original Abbreviated Application # 075582
Approval Date: 23-FEB-01
Trade Name: DICLOFENAC POTASSIUM
Dosage Form: TABLET
Applicant: EON LABS MANUFACTURING, INC
Active Ingredient(s): DICLOFENAC POTASSIUM
OTC/RX Status: RX

Original Abbreviated Application # 075837
Approval Date: 22-FEB-01
Trade Name: FLOXURIDINE
Dosage Form: INJECTABLE
Applicant: AMERICAN PHARMACEUTICAL PARTNERS INC
Active Ingredient(s): FLOXURIDINE
OTC/RX Status: RX

Original Abbreviated Application # 075129
Approval Date: 13-FEB-01
Trade Name: ALBUTEROL SULFATE
Dosage Form: SOLUTION
Applicant: ROXANE LABORATORIES INC
Active Ingredient(s): ALBUTEROL SULFATE
OTC/RX Status: RX

Original Abbreviated Application # 075848
Approval Date: 09-FEB-01
Trade Name: OXAPROZIN
Dosage Form: TABLET
Applicant: WATSON LABORATORIES
Active Ingredient(s): OXAPROZIN
OTC/RX Status: RX

Original Abbreviated Application # 075338
Approval Date: 09-FEB-01
Trade Name: CLOBETASOL PROPIONATE
Dosage Form: OINTMENT
Applicant: STIEFEL LABORATORIES INC
Active Ingredient(s): CLOBETASOL PROPIONATE
OTC/RX Status: RX

Original Abbreviated Application # 040410
Approval Date: 09-FEB-01
Trade Name: METHYLPHENIDATE HCL
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: DANBURY PHARMACAL INC
Active Ingredient(s): METHYLPHENIDATE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075647
Approval Date: 05-FEB-01
Trade Name: ETHINYL ESTRADIOL AND NORETHINDRONE ACETATE AND FERROUS FUMARATE
Dosage Form: TABLET
Applicant: WATSON LABORATORIES
Active Ingredient(s): NORETHINDRONE ACETATE; ETHINYL ESTRADIOL AND FERROUS FUMARATE
OTC/RX Status: RX

Original Abbreviated Application # 075548
Approval Date: 05-FEB-01
Trade Name: NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
Dosage Form: TABLET
Applicant: WATSON LABORATORIES
Active Ingredient(s): NORETHINDRONE ACETATE; ETHINYL ESTRADIOL
OTC/RX Status: RX

Original Abbreviated Application # 065061
Approval Date: 02-FEB-01
Trade Name: CLINDAMYCIN HYDROCHLORIDE
Dosage Form: CAPSULE
Applicant: RANBAXY LABORATORIES LIMITED
Active Ingredient(s): CLINDAMYCIN HYDROCHLORIDE
OTC/RX Status: RX

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

Original Abbreviated Application #: 075709
Tentative Approval Date: 28-FEB-01
Trade Name: FAMOTIDINE
Dosage Form: INJECTABLE
Applicant: AMERICAN PHARMACEUTICAL PARTNERS, INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX

Original Abbreviated Application #: 075797
Tentative Approval Date: 14-FEB-01
Trade Name: TAMOXIFEN CITRATE
Dosage Form: TABLET
Applicant: TEVA PHARMACEUTICALS USA INC
Active Ingredient(s): TAMOXIFEN CITRATE
OTC/RX Status: RX

Original Abbreviated Application #: 075302
Tentative Approval Date: 05-FEB-01
Trade Name: FAMOTIDINE
Dosage Form: TABLET
Applicant: GENEVA PHARMACEUTICALS INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX

Labeling Supplements to Original New Drug Applications

Application #: 050733 Labeling Supplement#: 005
To Original New Drug Application
Approval Date: 28-FEB-01
Trade Name: ZITHROMAX
Dosage Form: INJECTABLE
Applicant: PFIZER INC
Active Ingredient(s): AZITHROMYCIN DIHYDRATE
OTC/RX Status: RX

Application #:021178Labeling Supplement#:002
To Original New Drug Application
Approval Date: 28-FEB-01
Trade Name: GLUCOVANCE
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB
Active Ingredient(s): METFORMIN HYDROCHLORIDE; GLYBURIDE
OTC/RX Status: RX

Application #: 020622 Labeling Supplement#: 020
To Original New Drug Application
Approval Date: 28-FEB-01
Trade Name: COPAXONE
Dosage Form: INJECTABLE
Applicant: TEVA PHARMACEUTICALS USA INC
Active Ingredient(s): GLATIRAMER ACETATE
OTC/RX Status: RX

Application #: 020498 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 28-FEB-01
Trade Name: CASODEX
Dosage Form: TABLET
Applicant: ASTRAZENECA PHARMACEUTICALS LP
Active Ingredient(s): BICALUTAMIDE
OTC/RX Status: RX

Application #: 020236 Labeling Supplement #: 018
To Original New Drug Application
Approval Date: 25-FEB-00
Trade Name: SEREVENT
Dosage Form: AEROSOL, METERED
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): SALMETEROL XINAFOATE
OTC/RX Status: RX

Application #: 021174 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 23-FEB-01
Trade Name: MYLOTARG
Dosage Form: INJECTABLE
Applicant: WYETH AYERST LABORATORIES
Active Ingredient(s): GEMTUZUMAB OZOGAMICIN
OTC/RX Status: RX

Application #: 020903 Labeling Supplement#: 005
To Original New Drug Application
Approval Date: 23-FEB-01
Trade Name: REBETOL
Dosage Form: CAPSULE
Applicant: SCHERING PLOUGH RESEARCH INSTITUTE
Active Ingredient(s): RIBAVIRIN
OTC/RX Status: RX

Application #: 020764 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 23-FEB-01
Trade Name: LAMICTAL CD
Dosage Form: TABLET, CHEWABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): LAMOTRIGINE
OTC/RX Status: RX

Application #: 020241 Labeling Supplement#: 015
To Original New Drug Application
Approval Date: 23-FEB-01
Trade Name: LAMICTAL
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): LAMOTRIGINE
OTC/RX Status: RX

Application #: 016042 Labeling Supplement#: 069
To Original New Drug Application
Approval Date: 23-FEB-01
Trade Name: DYAZIDE
Dosage Form: CAPSULE
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): TRIAMTERENE; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX

Application #: 011265 Labeling Supplement#: 027
To Original New Drug Application
Approval Date: 23-FEB-01
Trade Name: PHENERGAN EXPECTORANT W/ DEXTROMETHORPHAN
Dosage Form: SYRUP
Applicant: WYETH AYERST LABORATORIES
Active Ingredient(s): PROMETHAZINE HYDROCHLORIDE; DEXTROMETHOPPHAN
OTC/RX Status: RX

Application #: 008604 Labeling Supplement#: 026
To Original New Drug Application
Approval Date: 23-FEB-01
Trade Name: PHENERGAN VC
Dosage Form: SYRUP
Applicant: WYETH AYERST LABORATORIES
Active Ingredient(s): PROMETHAZINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 008306 Labeling Supplement#: 029
To Original New Drug Application
Approval Date: 23-FEB-01
Trade Name: PHENERGAN W/ CODEINE
Dosage Form: SYRUP
Applicant: WYETH AYERST LABORATORIES
Active Ingredient(s): CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 021208 Labeling Supplement #: 001
To Original New Drug Application
Approval Date: 22-FEB-01
Trade Name: REMERON
Dosage Form: TABLET, ORALLY DISINTEGRATING
Applicant: ORGANON INC
Active Ingredient(s): MIRTAZAPINE
OTC/RX Status: RX

Application #: 020990 Labeling Supplement #: 005
To Original New Drug Application
Approval Date: 22-FEB-01
Trade Name: ZOLOFT
Dosage Form: CONCENTRATE
Applicant: PFIZER PHARMACEUTICALS INC
Active Ingredient(s): SERTRALINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 019839 Labeling Supplement #: 037
To Original New Drug Application
Approval Date: 22-FEB-01
Trade Name: ZOLOFT
Dosage Form: TABLET
Applicant: PFIZER PHARMACEUTICALS INC
Active Ingredient(s): SERTRALINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 019839 Labeling Supplement #: 027
To Original New Drug Application
Approval Date: 22-FEB-01
Trade Name: ZOLOFT
Dosage Form: TABLET
Applicant: PFIZER PHARMACEUTICALS INC
Active Ingredient(s): SERTRALINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 019279 Labeling Supplement #: 010
To Original New Drug Application
Approval Date: 22-FEB-01
Trade Name: DIMETANE-DX
Dosage Form: SYRUP
Applicant: AH ROBINS CO
Active Ingredient(s): BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020098 Labeling Supplement #: 012
To Original New Drug Application
Approval Date: 20-FEB-01
Trade Name: MIVACRON
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): MIVACURIUM CHLORIDE
OTC/RX Status: RX

Application #: 016295 Labeling Supplement #: 035
To Original New Drug Application
Approval Date: 20-FEB-01
Trade Name: HYDREA
Dosage Form: CAPSULE
Applicant: BRISTOL MYERS SQUIBB CO
Active Ingredient(s): HYDROXYUREA
OTC/RX Status: RX

Application #: 020286 Labeling Supplement #: 004
To Original New Drug Application
Approval Date: 16-FEB-01
Trade Name: MONOPRIL-HCT
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB
Active Ingredient(s): HYDROCHLOROTHIAZIDE; FOSINOPRIL SODIUM
OTC/RX Status: RX

Application #: 074843 Labeling Supplement #: 003
To Original New Drug Application
Approval Date: 15-FEB-01
Trade Name: PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
Dosage Form: TABLET
Applicant: VINTAGE PHARMACEUTICALS INC
Active Ingredient(s): PROPOXYPHENE NAPSYLATE; ACETAMINOPHEN
OTC/RX Status: RX

Application #: 020710 Labeling Supplement #: 009
To Original New Drug Application
Approval Date: 15-FEB-01
Trade Name: PAXIL
Dosage Form: SUSPENSION, LIQUID
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): PAROXETINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020031 Labeling Supplement #: 031
To Original New Drug Application
Approval Date: 15-FEB-01
Trade Name: PAXIL
Dosage Form: TABLET
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): PAROXETINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 018997 Labeling Supplement #: 018
To Original New Drug Application
Approval Date: 15-FEB-01
Trade Name: LIPOSYN II 10%
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): SAFFLOWER OIL; SOYBEAN OIL
OTC/RX Status: RX

Application #: 018991 Labeling Supplement #: 017
To Original New Drug Application
Approval Date: 15-FEB-01
Trade Name: LIPOSYN II 20%
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): SAFFLOWER OIL; SOYBEAN OIL
OTC/RX Status: RX

Application #: 018658 Labeling Supplement#: 014
To Original New Drug Application
Approval Date: 15-FEB-01
Trade Name: DELSYM
Dosage Form: SUSPENSION, EXTENDED RELEASE
Applicant: MEDEVA PHARMACEUTICALS INC
Active Ingredient(s): DEXTROMETHORPHAN POLISTIREX
OTC/RX Status: OTC

Application #: 016812 Labeling Supplement#: 026
To Original New Drug Application
Approval Date: 14-FEB-01
Trade Name: KETALAR
Dosage Form: INJECTABLE
Applicant: PARKEDALE PHARMACEUTICALS INC
Active Ingredient(s): KETAMINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 021135 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 13-FEB-01
Trade Name: VENOFER
Dosage Form: INJECTABLE
Applicant: LUITPOLD PHARMACEUTICALS INC
Active Ingredient(s): IRON SUCROSE
OTC/RX Status: RX

Application #: 018155 Labeling Supplement#: 022
To Original New Drug Application
Approval Date: 13-FEB-01
Trade Name: OPTICROM
Dosage Form: SOLUTION
Applicant: ALLERGAN INC
Active Ingredient(s): CROMOLYN SODIUM
OTC/RX Status: RX

Application #: 019640 Labeling Supplement#: 026
To Original New Drug Application
Approval Date: 12-FEB-01
Trade Name: HUMATROPE
Dosage Form: INJECTABLE
Applicant: ELI LILLY AND CO
Active Ingredient(s): SOMATROPIN RECOMBINANT
OTC/RX Status: RX

Application #: 019516 Labeling Supplement#: 015
To Original New Drug Application
Approval Date: 12-FEB-01
Trade Name: MS CONTIN
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: PURDUE FREDERICK CO
Active Ingredient(s): MORPHINE SULFATE
OTC/RX Status: RX

Application #: 019107 Labeling Supplement#: 048
To Original New Drug Application
Approval Date: 12-FEB-01
Trade Name: PROTROPIN
Dosage Form: INJECTABLE
Applicant: GENENTECH INC
Active Ingredient(s): SOMATREM
OTC/RX Status: RX

Application #: 021071 Labeling Supplement#: 006
To Original New Drug Application
Approval Date: 08-FEB-01
Trade Name: AVANDIA
Dosage Form: TABLET
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): ROSIGLITAZONE MALEATE
OTC/RX Status: RX

Application #: 020357 Labeling Supplement #: 022
To Original New Drug Application
Approval Date: 08-FEB-01
Trade Name: GLUCOPHAGE
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): METFORMIN HYDROCHLORIDE
OTC/RX Status: RX

Application #: 050706 Labeling Supplement #: 007
To Original New Drug Application
Approval Date: 06-FEB-01
Trade Name: MERREM I.V.
Dosage Form: INJECTABLE
Applicant: ASTRAZENECA UK LTD
Active Ingredient(s): MEROPENEM
OTC/RX Status: RX

Application #: 050622 Labeling Supplement #: 014
To Original New Drug Application
Approval Date: 06-FEB-01
Trade Name: SUPRAX
Dosage Form: SUSPENSION
Applicant: LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
Active Ingredient(s): CEFIXIME
OTC/RX Status: RX

Application #: 050606 Labeling Supplement #: 014
To Original New Drug Application
Approval Date: 06-FEB-01
Trade Name: VANCOCIN HCL
Dosage Form: CAPSULE
Applicant: ELI LILLY AND CO
Active Ingredient(s): VANCOMYCIN HYDROCHLORIDE
OTC/RX Status: RX

Application #: 021132 Labeling Supplement #: 001
To Original New Drug Application
Approval Date: 06-FEB-01
Trade Name: ZYVOX
Dosage Form: SUSPENSION
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): LINEZOLID
OTC/RX Status: RX

Application #: 021131 Labeling Supplement #: 001
To Original New Drug Application
Approval Date: 06-FEB-01
Trade Name: ZYVOX
Dosage Form: INJECTABLE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): LINEZOLID
OTC/RX Status: RX

Application #: 021130 Labeling Supplement #: 001
To Original New Drug Application
Approval Date: 06-FEB-01
Trade Name: ZYVOX
Dosage Form: TABLET
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): LINEZOLID
OTC/RX Status: RX

Application #: 018976 Labeling Supplement #: 009
To Original New Drug Application
Approval Date: 06-FEB-01
Trade Name: LEVATOL
Dosage Form: TABLET
Applicant: SCHWARZ PHARMA INC
Active Ingredient(s): PENBUTOLOL SULFATE
OTC/RX Status: RX

Application #: 020963 Labeling Supplement #: 005
To Original New Drug Application
Approval Date: 05-FEB-01
Trade Name: TIMOLOL MALEATE
Dosage Form: SOLUTION
Applicant: FALCON PHARMACEUTICALS LTD
Active Ingredient(s): TIMOLOL MALEATE
OTC/RX Status: RX

Application #: 019757 Labeling Supplement #: 010
To Original New Drug Application
Approval Date: 05-FEB-01
Trade Name: CHIBROXIN
Dosage Form: SOLUTION
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): NORFLOXACIN
OTC/RX Status: RX

Application #: 020080 Labeling Supplement #: 027
To Original New Drug Application
Approval Date: 02-FEB-01
Trade Name: IMITREX
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): SUMATRIPTAN SUCCINATE
OTC/RX Status: RX

Application #: 020080 Labeling Supplement #: 025
To Original New Drug Application
Approval Date: 02-FEB-01
Trade Name: IMITREX
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): SUMATRIPTAN SUCCINATE
OTC/RX Status: RX

Application #: 020080 Labeling Supplement #: 024
To Original New Drug Application
Approval Date: 02-FEB-01
Trade Name: IMITREX
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): SUMATRIPTAN SUCCINATE
OTC/RX Status: RX

Application #: 020080 Labeling Supplement #: 021
To Original New Drug Application
Approval Date: 02-FEB-01
Trade Name: IMITREX
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): SUMATRIPTAN SUCCINATE
OTC/RX Status: RX

Application #: 019047 Labeling Supplement#: 020
To Original New Drug Application
Approval Date: 01-FEB-01
Trade Name: PLASMA-LYTE 56 IN PLASTIC CONTAINER
Dosage Form: INJECTABLE
Applicant: BAXTER HEALTHCARE CORP
Active Ingredient(s): SODIUM CHLORIDE; POTASSIUM ACETATE; MAGNESIUM ACETATE TETRAHYDRATE
OTC/RX Status: RX

Application #: 017451 Labeling Supplement#: 053
To Original New Drug Application
Approval Date: 01-FEB-01
Trade Name: PLASMA-LYTE 148 AND DEXTROSE 5% IN PLASTIC CONTAINER
Dosage Form: INJECTABLE
Applicant: BAXTER HEALTHCARE CORP
Active Ingredient(s): DEXTROSE; SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM ACETATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE
OTC/RX Status: RX

Application #: 017438 Labeling Supplement#: 053
To Original New Drug Application
Approval Date: 01-FEB-01
Trade Name: PLASMA-LYTE R IN PLASTIC CONTAINER
Dosage Form: INJECTABLE
Applicant: BAXTER HEALTHCARE CORP
Active Ingredient(s): SODIUM ACETATE; SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE
OTC/RX Status: RX

Application #: 017390 Labeling Supplement#: 054
To Original New Drug Application
Approval Date: 01-FEB-01
Trade Name: PLASMA-LYTE M AND DEXTROSE 5% IN PLASTIC CONTAINER
Dosage Form: INJECTABLE
Applicant: BAXTER HEALTHCARE CORP
Active Ingredient(s): DEXTROSE; SODIUM ACETATE; SODIUM LACTATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE
OTC/RX Status: RX

Application #: 017385 Labeling Supplement#: 051
To Original New Drug Application
Approval Date: 01-FEB-01
Trade Name: PLASMA-LYTE 56 AND DEXTROSE 5% IN PLASTIC CONTAINER
Dosage Form: INJECTABLE
Applicant: BAXTER HEALTHCARE CORP
Active Ingredient(s): MAGNESIUM ACETATE TETRAHYDRATE; DEXTROSE; SODIUM CHLORIDE; POTASSIUM ACETATE
OTC/RX Status: RX

Application #: 017378 Labeling Supplement#: 058
To Original New Drug Application
Approval Date: 01-FEB-01
Trade Name: PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER
Dosage Form: INJECTABLE
Applicant: BAXTER HEALTHCARE CORP
Active Ingredient(s): SODIUM CHLORIDE; SODIUM ACETATE; SODIUM GLUCONATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE
OTC/RX Status: RX