http://www.fda.gov/cder/orange/appendix_a.txt
4, ACETAMINOPHEN TYLENOL W/ CODEINE, ACETAMINOPHEN TYLENOL, ACETAMINOPHEN (OTC) TYLOX, ACETAMINOPHEN TYLOX-325, ACETAMINOPHEN TYMTRAN, CERULETIDE DIETHYLAMINE TYZINE, TETRAHYDROZOLINE HYDROCHLORIDE TZ-3, TIOCONAZOLE (OTC) ** U ** U-CORT, HYDROCORTISONE ACETATE U-GENCIN, GENTAMICIN SULFATE UCEPHAN, SODIUM BENZOATE ULO, CHLOPHEDIANOL HYDROCHLORIDE ULTANE, SEVOFLURANE ULTIVA...
1999 Warning Letters and Untitled Letters to Pharmaceutical Companies
DDMAC 1/21/99 1/26/99 Prograf (tacrolimus) capsules Fujisawa USA DDMAC 1/4/99 1/11/99 Remeron (mitrazapine) tablets Organon DDMAC 1/5/99 1/14/99 Risperdal (risperidone) tablets and oral solution Janssen Research DDMAC 1/5/99 1/14/99 Trivora, Zovia, Necon, Levora, Nor-QD Tablets Watson Laboratories DDMAC 1/26/99 2/12/99 February Arava (leflunomide) tablets Hoechst Marion Roussel DDMAC...
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,...
author: AUTHOR
FDA Drug Approvals List January 2002
- Drug Approvals for January 2002 Definitions and Notes Original New Drug Applications Efficacy Supplemental New Drug Applications Application #: 020837 Efficacy Supplement #: 006 Type: SE5 to Original New Drug Application Approval Date: 30-JAN-02 Trade Name: XOPENEX Dosage Form: SOLUTION Applicant: SEPRACOR, INC Active Ingredient(s): LEVALBUTEROL HYDROCHLORIDE OTC...
Prescription and OTC Drug Product List 6/2002
-D- + WYETH AYERST 20,000 UNITS/VIAL N17055 003 JUN DISC -A- @ 20,000 UNITS/VIAL N17055 003 JUN DISC CHORIONIC GONADOTROPIN -D- + STERIS 2,000 UNITS/VIAL N17016 011 FEB 16, 1990 JUN DISC -A- @ 2,000 UNITS/VIAL N17016 011 FEB 16, 1990 JUN DISC GRANISETRON HYDROCHLORID E SOLUTION; ORAL KYTRIL -D- + ROCHE EQ 2MG BASE/10ML N21238 001 JUN 27, 2001 JUN DISC -A- @ EQ 2MG BASE/10ML N21238...
Efficacy Supplements Approved in Calendar Year 2002 (SE1-SE7 AND SE8s
LEVALBUTEROL HYDROCHLORIDE SEPRACOR 20-837 SE5 006 30-Mar-01 30-Jan-02 - 10.1 Provides for the use of Xopenex (levalbuterol inhalation solution) for the treatment or prevention of bronchospasm in children 6 years of age and older with reversible obstructive airway disease ----------- This list is updated quarterly.- Updated through 12/31/02 ----------------...
author: Darlene Norris
Prescription and OTC Drug Product List 3/1999
Prescription and Over-the-Counter Drug Product List - 19th Edition Cumulative Supplement Number 3: March 1999 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE CALCIUM CHLORIDE; DEXTROSE; GLUTATHIONE DISULFIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CAPSULE; ORAL CHLORIDE; SODIUM...
FDA Drug Approvals List- March 1999
Drug Approvals for March 1999 Definitions and Notes March 1999 Original New Drug Applications Original Application #: 020966 Approval Date: 30-MAR-99 Trade Name: SPORANOX Chemical Type: 3 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: JANSSEN RESEARCH FDN DIV JOHNSON AND JOHNSON Active Ingredient(s): ITRACONAZOLE OTC/RX Status: RX Indication(s): For the treatment of...
[2000] [Open Forum] LEVALBUTEROL USE IN THE EMERGENCY DEPARTMENT (ED) INCREASES PEF OVER RACEMIC ALBUTEROL.
Mueller® Instruments - Avian Flu Preparedness - Clinical Laboratory - Infection Prevention - Latex Allergy Management - Physician Office - Respiratory Therapy - Safety - Scientific and Production Products - Best Value Products - e-Business Solutions - InventoryLink Program - OnSite SM Services - OptiFreight Program - OrderConnect System - ValueLink® Stockless Delivery -...
AARC Respiratory Abstracts: brought to you by Cardinal Health
Investor Relations - Careers - Our Businesses - About Us - News - - - Browse Catalog - Allegiance® Private Brand ---Medical/Surgical Products - Convertors® Infection Control - Gloves - Medi-Vac® Products - National Brands: Distributed ---Products - Prep Products - Presource® Products and Services - Respiratory Care - Scientific and Production Products - SP®...
AARC Respiratory Abstracts: brought to you by Cardinal Health
-- EVALUATION OF PEAK PRESSURE DURING CPAP OF 5 cm H2O WITH PSV OF 10 cm H2O -- A RANDOMIZED CONTROLLED TRIAL COMPARING A BREATH ACTIVATED NEBULIZER TO STANDARD INTERMITTENT AND ONE HOUR CONTINUOUS ALBUTER -- Report on Impact of Introduction of Mechanical Ventilation on Neonatal Survival in a Public Hospital in Belize -- TRANSITION TO A PYXIS SYSTEM FOR DISPENSING RESPIRATORY...
AARC Respiratory Abstracts: brought to you by Cardinal Health
Contact us -|- Sign in -|- U.S.A. -- HELIOX DELIVERY USING THE AVEA VENTILATOR. -- The Impact of Xopenex Substitution In place Of Albuterol. -- WEANING IN LONG TERM ACUTE CARE: PHYSICIAN-DIRECTED VS PROTOCOL-DIRECTED MANAGEMENT -- RESULTS AFTER ONE YEAR OF USE: AUTOMATICALLY INVOKED PROTOCOL FOR VENTILATOR MANAGEMENT. -- Sustained Elevation in Pulmonary Dead-Space...
AARC Respiratory Abstracts: brought to you by Cardinal Health
-- EVALUATION OF PEAK PRESSURE DURING CPAP OF 5 cm H2O WITH PSV OF 10 cm H2O -- A RANDOMIZED CONTROLLED TRIAL COMPARING A BREATH ACTIVATED NEBULIZER TO STANDARD INTERMITTENT AND ONE HOUR CONTINUOUS ALBUTER -- Report on Impact of Introduction of Mechanical Ventilation on Neonatal Survival in a Public Hospital in Belize -- TRANSITION TO A PYXIS SYSTEM FOR DISPENSING RESPIRATORY...
Validating Xopenex Kings Daughter FINAL.qxd
According to Debbie Williams, Director of Pulmonary Services at King's Daughters, "We began hearing about Xopenex overuse, and both our therapists and our pharmacy felt that the drug was being used excessively." This impression was echoed at other hospitals, and the resultant cost increases at client hospitals triggered a clinical initiative at Cardinal Health. The company's...
author: sroberts
Validating Xopenex Kings Daughter FINAL.qxd page 1
author: sroberts
Beta2-agonists for chronic obstructive pulmonary disease (COPD) - [Medication] - Quest Diagnostics Patient Health Library
Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About - References Beta2-agonists for chronic obstructive pulmonary disease (COPD) - [Medication] - Quest Diagnostics Patient Health Library Beta2-agonists for chronic obstructive pulmonary disease (COPD) - [Medication] - Quest Diagnostics Patient Health Library Advair Diskus,...
Short-acting beta2-agonists for quick relief of asthma symptoms - [Medication] - Quest Diagnostics Patient Health Library
Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About - References Short-acting beta2-agonists for quick relief of asthma symptoms - [Medication] - Quest Diagnostics Patient Health Library Short-acting beta2-agonists for quick relief of asthma symptoms - [Medication] - Quest Diagnostics Patient Health Library Allergies and...
Beta2-agonists for chronic obstructive pulmonary disease (COPD) - [Medication] - Quest Diagnostics Patient Health Library
Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About - References Beta2-agonists for chronic obstructive pulmonary disease (COPD) - [Medication] - Quest Diagnostics Patient Health Library Beta2-agonists for chronic obstructive pulmonary disease (COPD) - [Medication] - Quest Diagnostics Patient Health Library Advair Diskus,...
Asma - UMHS Approved Clinical Care Guideline
Asma Patient Education Handout associated with UMHS Clinical Care Guideline This information is not a tool for self-diagnosis or a substitute for medical treatment. Medicamentos contra el asma Existen dos clases principales de medicamentos contra el asma: los de - rescate (de accion inmediata) y los de control. Algunos de los medicamentos de rescate mas comunes son: Albuterol ...
Pediatric Advisor 2004.2: Bronchodilator: Short-Acting Beta2-Agonist
Pediatric Health Topics | All Health Topics Mott Children's Hospital | Pediatric Services Find a UMHS Doctor Search Pediatric Topics Search All Topics This information is approved and/or reviewed by U-M Health System providers but it is not a tool for self-diagnosis or a substitute for medical treatment. Some other names for this medicine are albuterol, pirbuterol, and ...
Sepracor
Press | Search | Glossary | Terms & Conditions -- Sepracor Sepracor Sepracor, Sepracor Inc., SEPR, Soltara, Xopenex, Estorra, pharmaceutical, pharmaceuticals, levalbuterol, tecastemizole, Estorra, esopiclone, eszopiclone, amlodipine, allergies, asthma, antihistamine, COPD, chronic obstructive pulmonary disease, sleep disorders, insomnia, transient insomnia, chronic...
Sepracor
Press | Search | Glossary | Terms & Conditions -- Sepracor Sepracor Sepracor, Sepracor Inc., SEPR, Soltara, Xopenex, Estorra, pharmaceutical, pharmaceuticals, levalbuterol, tecastemizole, Estorra, esopiclone, eszopiclone, amlodipine, allergies, asthma, antihistamine, COPD, chronic obstructive pulmonary disease, sleep disorders, insomnia, transient insomnia, chronic...
Sepracor - About Sepracor
Home / About Sepracor / Corporate Agreements History Leadership Corporate Agreements ---- Partners Chart Corporate Agreements ACADIA Pharmaceuticals INC. Abbott Laboratories/Ross Products Division In March 2004, Sepracor announced an amendment to its agreement with the Ross Products Division of Abbott Laboratories (referred to as Ross) for the co-promotion of XOPENEX ®...
Sepracor - Media Room: Company Description
Home / Press / Company Description Executive Biographies Board of Directors Company Description Sepracor's History Leadership Media Contacts Product Pipeline Webcasts and Presentations Company Description Sepracor Inc. Sepracor's drug development program has yielded an extensive portfolio of pharmaceutical compound candidates, with a focus on respiratory and central nervous system...
Sepracor - Therapeutic Areas: Respiratory
Home / Therapeutic Areas / Respiratory Respiratory ---- XOPENEX ® ---- Arformoterol Central Nervous System Additional Opportunities Chemistry & Pharma Sciences Drug Discovery Respiratory Sepracor's first self-developed and self-commercialized product, XOPENEX ® brand levalbuterol HCl inhalation solution, was introduced in 1999 for the treatment or prevention...