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1996 and Older - New Drug Application (NDA)
New Drug Approval Packages These drug approval packages, sorted by product trade name, are supplied by the CDER Freedom of Electronic Information Office
20195/S-002 5/20/96 8/2/99 Fragmin/dalteparin sodium Injection [1.5 MB] Pharmacia and Upjohn 020287/S005 9/24/1996 2/4/1998 Heptolite, Kit for the Preparation of Technetium Tc 99m Disofenin Merck 18467/ S-13 & S-14 12/29/1993 8/5...
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http://www.fda.gov/cder/orange/appendix_a.txt
4, ACETAMINOPHEN PHENAPHEN-650 W/ CODEINE, ACETAMINOPHEN PHENAZINE, PHENDIMETRAZINE TARTRATE PHENAZINE-35, PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE PHENERGAN FORTIS, PROMETHAZINE HYDROCHLORIDE PHENERGAN PLAIN, PROMETHAZINE HYDROCHLORIDE PHENERGAN VC W/ CODEINE, CODEINE PHOSPHATE PHENERGAN VC, PHENYLEPHRINE HYDROCHLORIDE PHENERGAN W/ CODEINE, CODEINE...
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http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt
PENTOXYPHYLLINE AS MANUFACTURED IN BANGALORE INDIA 14183 25-May-99 BASIC VEGETABLE PRODUCTS NUTRACEUTICAL GARLIC PRODUCT A10000 AS MANUFACTURED IN KING CITY CALIFORNIA 14184 28-May-99 MALLINCKRODT GMBH SODIUM PHOSPHATE DIBASIC USP POWDER (DRIED) AS MANUFACTURED IN ST LOUIS MO 14185 01-Jun-99 SHASUN CHEMICALS AND DRUGS LTD NAPROXEN SODIUM USP AS MANUFACTURED IN PONDICHERRY INDIA 14187...
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Prescription and Over-the-Counter Drug Product List: 7/2003
>A> @ FERRING 5,000 UNITS/VIAL N17055 001 JUL CAHN >A> @ 10,000 UNITS/VIAL N17055 002 JUL CAHN >A> @ 20,000 UNITS/VIAL N17055 003 JUL CAHN >D> @ WYETH AYERST 5,000 UNITS/VIAL N17055 001 JUL CAHN >D> @ 10,000 UNITS/VIAL N17055 002 JUL CAHN >D> @ 20,000 UNITS/VIAL N17055 003 JUL CAHN GRANISETRON HYDROCHLORIDE SOLUTION; ORAL KYTRIL >D> @ ROCHE EQ 2MG BASE/10ML N21238 001 JUN 27, 2001...
author: AUTHOR
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Prescription and Over-the-Counter Drug Product List: 3/2003
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL FIORICET W/ CODEINE -D- AB + NOVARTIS 325MG;50MG;40MG;30MG N20232 001 JUL 30, 1992 MAR CAHN -A- AB + WATSON PHARMS 325MG;50MG;40MG;30MG N20232 001 JUL 30, 1992 MAR CAHN ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL CODRIX -A- + ANDRX PHARMS 500MG;30MG N40441 001...
author: AUTHOR
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LIST OF APPROVED DRUGS FOR WHICH ADDITIONAL PEDIATRIC INFORMATION
DOCKET NO
Anesthetic, Critical Care And Addiction Drug Products Bupropion Treatment of depression
Metabolic And Endocrine Drug Products Dexmedetomidine Sedation of initially intubated and mechanically ventilated patients in an ICU setting
Prolonging the time to recurrence of supraventricular tachycardia
Anesthetic, Critical Care And Addiction Drug Products Isotretinoin...
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Prescription and OTC Drug Product List 2/2002
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST AMOXICILLIN; CLAVULANATE POTASSIUM FOR SUSPENSION; ORAL AUGMENTIN '400' -D- + GLAXOSMITHKLINE 400MG/5ML;EQ 57MG BASE/5ML N50725 002 MAY 31, 1996 FEB CRLD -A- 400MG/5ML;EQ 57MG BASE/5ML N50725 002 MAY 31, 1996 FEB CRLD AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET; ORAL ...
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Prescription and OTC Drug Product List 1/2002
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -A- AA KV PHARM 500MG/15ML;7.5MG/15ML N40366 001 JAN 23, 2002 JAN NEWA AMPHOTERICIN B INJECTABLE, LI COMPLEX; INJECTION ABELCET -A- + ELAN PHARMS 5MG/ML N50724 001 NOV 20, 1995 JAN CAHN -D- + LIPOSOME 5MG/ML N50724 001 NOV 20, 1995 JAN...
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C:\Data\WPfiles\Labeling Review\Protopam\Protopam SLR024 Geriatric \ AP ltr.doc
Pralidoxime also slows the process of aging of phosphorylated cholinesterase to a nonreactivatable form, and detoxifies certain organophosphates by direct chemical Protopam ® Injection Supplement S- 024 DRAFT Package Insert Page 2 reaction
Pralidoxime is distributed throughout the extracellular water; it is not bound to plasma protein
Precautions GENERAL ...
author: Robbin Nighswander
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C:\Data\WPfiles\Labeling Review\Protopam\Protopam SLR024 Geriatric \ AP ltr.doc page 5
author: Robbin Nighswander
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C:\Data\WPfiles\Labeling Review\Protopam\Protopam SLR024 Geriatric \ AP ltr.doc page 2
author: Robbin Nighswander
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C:\Data\WPfiles\Labeling Review\Protopam\Protopam SLR024 Geriatric \ AP ltr.doc page 1
author: Robbin Nighswander
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FDA Drug Approvals List- April 1998
Application #: 020555 Efficacy Supplement#: 003 Type: SE1 to Original New Drug Application Approval Date: 01-APR-98 Trade Name: AXID AR Dosage Form: TABLET Applicant: WHITEHALL ROBINS HEALTHCARE Active Ingredient(s): NIZATIDINE OTC/RX Status: OTC Efficacy Claim: Provides for treatment of episodic heartburn, acid indigestion and sour stomach Application #: 020393 Efficacy Supplement#:...
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may20lst.PDF
Pimozide Tourettes No No Yes No Pralidoxime Component of antinerve gas Yes Yes Yes Yes Quetiapine Management of the manifestations of psychotic disorders No No Yes Yes Risperidone Manifestations of psychotic disorders, No No Yes Yes Scopolamine Motion sickness No No Yes Yes Sertraline 1) Depression No No Yes Yes 2) Obsessive compulsive disorder No No Yes Yes 3) Panic disorder...
author: Unknown
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DDPA December 1995
74-589 MINOXIDIL LEMMON MINOXIDIL 15-DEC-95 (SOLUTION) SELLERSVILLE, PA 2% 18960 (HAIR GROWTH STIMULATOR) 74-643 MINOXIDIL BAUSCH AND LOMB MINOXIDIL 22-DEC-95 (SOLUTION) TAMPA, FL 2% 33637 (HAIR GROWTH STIMULATOR) 74-418 CAPTOPRIL ENDO CAPTOPRIL 28-DEC-95 (TABLET) GARDEN CITY, NY 12.5MG 11530 25MG 50MG 100MG (ANGIOTENSIN CONVERTING ENZYME INHIBITOR) ***LABELING SUPPLEMENTS TO...
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http://www.fda.gov/cder/da/ddpa91.wpd
19 981 ULTRATAG MALLINCKRODT TECHNETIUM TC-99M LABELED 03 01 91 (INJECTABLE) ST LOUIS, MO RED BLOOD CELL KIT 63134 (RADIOACTIVE DIAGNOSTIC) 20-048 DEXTROSE 50% BAXTER DEXTROSE 03-18-91 IN PLASTIC CONTAINER ROUND LAKE, IL 50GM/100ML (INJECTABLE) 60073 (PERITONEAL DIALYSATE) 20 018 METHASITE INSITE VISION FLUOROMETHOLONE 03 19 91 (SUSPENSION/DROPS) ALAMEDA, CA 0.1% 94501 ...
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Insecticide Poisoning: Poisoning: Merck Manual Home Edition
Section Accidents and Injuries Subject Poisoning Insecticide Poisoning The properties that make insecticides deadly to insects can sometimes make them poisonous to humans.
Pyrethrins and pyrethroids, which are commonly used insecticides derived from flowers, usually are not poisonous to humans.
Organophosphate and carbamate insecticides make certain nerves "fire" erratically,...
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Index: PR: Merck Manual Home Edition
Search Recent Searches Index Sections A B C D E F G H I J K L M N O P Q R S T U V W X Y Z Accidents and Injuries Blood Disorders Bone, Joint, and Muscle Disorders Brain, Spinal Cord, and Nerve Disorders Cancer Children's Health Issues Digestive Disorders Disorders of Nutrition and Metabolism Drugs Ear, Nose, and Throat Disorders Eye Disorders Fundamentals Heart and Blood Vessel...
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THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, OCUFEN to PYRIDIUM
Trade Names of Some Commonly Used Drugs TRADE AND GENERIC NAMES OF COMMONLY USED DRUGS OCUFEN to PYRIDIUM Trade Name Generic OCUFEN Flurbiprofen OCUPRESS Carteolol OMNIPEN Ampicillin ONCOVIN Vincristine OPHTHAINE Proparacaine OPHTHETIC Proparacaine ORETIC Hydrochlorothiazide ORETON Methyltestosterone ORINASE Tolbutamide ORUDIS Ketoprofen ORUVAIL Ketoprofen OXANDRIN Oxandrolone...
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THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, Paclitaxel to Rosiglitazone
Trade Names of Some Commonly Used Drugs GENERIC AND TRADE NAMES OF COMMONLY USED DRUGS Paclitaxel to Rosiglitazone Generic Trade Name Paclitaxel TAXOL Pamidronate AREDIA Pancrelipase PANCREASE, VIOKASE Pancuronium PAVULON Papaverine PAVABID Paramethadione PARADIONE Paramethasone HALDRONE Pargyline EUTONYL Paromomycin HUMATIN Paroxetine PAXIL Penbutolol LEVATOL Penciclovir DENAVIR...
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Insecticide Poisoning: Poisoning: Merck Manual Home Edition
Search Recent Searches Index Sections A B C D E F G H I J K L M N O P Q R S T U V W X Y Z Accidents and Injuries Blood Disorders Bone, Joint, and Muscle Disorders Brain, Spinal Cord, and Nerve Disorders Cancer Children's Health Issues Digestive Disorders Disorders of Nutrition and Metabolism Drugs Ear, Nose, and Throat Disorders Eye Disorders Fundamentals Heart and Blood Vessel...
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Specificity Table TOX.xls
Tested (ng/ ml) Previcid Lansoprazole Anti- ulcerative 100,000 Prilosec Omeprazole Anti- ulcerative 100,000 Primacor Milrinone Cardiotonic 100,000 Primaquine Primaquine Antimalarial 100,000 Prinivil Lisinopril Antihypertensive 100,000 Proaqua Benzthiazide Diuretic 100,000 Proasma Methoxyphenamine Bronchodilator 100,000 Procardia Nifedipine Antianginal 100,000 Prolixin Fluphenazine...
author: Biosite Incorporated
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Specificity Table TOX.xls page 22
author: Biosite Incorporated
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http://www.crha-health.ab.ca/em/reseduc/coreround/BetaB%20and%20OrganoP2004.ppt
Lippinocott-Raven New York Pralidoxmine • Reverses muscular weakness and fasiculations – – – 1-2g bolus (20-40mg/kg in children) over 30-60 min or infusion of 200-500mg/h (5-10mg/kg/h in children) titrating to desired clinical response • • Must give early before aging has occurred and enzyme is irreversibly bound Pralidoxime • The OP Fenthion...
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THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, OCUFEN to PYRIDIUM
Trade Names of Some Commonly Used Drugs TRADE AND GENERIC NAMES OF COMMONLY USED DRUGS OCUFEN to PYRIDIUM Trade Name Generic OCUFEN Flurbiprofen OCUPRESS Carteolol OMNIPEN Ampicillin ONCOVIN Vincristine OPHTHAINE Proparacaine OPHTHETIC Proparacaine ORETIC Hydrochlorothiazide ORETON Methyltestosterone ORINASE Tolbutamide ORUDIS Ketoprofen ORUVAIL Ketoprofen OXANDRIN Oxandrolone...
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