Drug Approvals - A ANDA 76-130 9/26/02 Albuterol Sulfate Inhalation Solution, 0.083% (base), Breath Limited ANDA 76-370 11/24/03 -- - - Albuterol Sulfate Inhalation Solution, 0.0417% (base), Tentatively Approved Nephron Pharmaceuticals Corporation ANDA 76-355 11/7/03 -- - - Albuterol Sulfate Inhalation Solution, 0.5% (base) Nephron Pharmaceuticals Corporation ANDA 74...
http://www.fda.gov/cder/orange/appendix_a.txt APPENDIX A PRODUCT NAME INDEX ** 0 ** 0, AMOXICILLIN ** 8 ** 8-HOUR BAYER, ASPIRIN (OTC) 8-MOP, METHOXSALEN ** A ** A-HYDROCORT, HYDROCORTISONE SODIUM SUCCINATE A-METHAPRED, METHYLPREDNISOLONE SODIUM SUCCINATE A-N STANNOUS AGGREGATED ALBUMIN, TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT A-POXIDE, CHLORDIAZEPOXIDE HYDROCHLORIDE A.P.L., GONADOTROPIN, CHORIONIC A/T/S, ERYTHROMYCIN ABELCET,...
NDA Approvals for Calendar Year 2001 Braun 5 S 21-Feb-01 21-235 Prozac Weekly Fluoxetine Hydrochloride Eli Lilly 3 S 26-Feb-01 21-169 Reminyl Galantamine Hydrobromide Janssen Research 1 S 28-Feb-01 21-082 Tavist Allergy/Sinus/Headache Acetaminophen/Clemastine Fumarate/Pseudoephedrine Hydrochloride Novartis 4 S 01-Mar-01 21-257 Travatan Travoprost Alcon 1 P 16-Mar-01 21-262 Alphagan P Brimonidine Tartrate Allergan 3 S 16...
author: Brenda Harmon
FDA Drug Approvals List April 2001 - Drug Approvals for April 2001 Definitions and Notes Original New Drug Applications Original Application #: 020949 Approval Date: 30-APR-01 Trade Name: ACCUNEB Chemical Type: 5 Therapeutic Potential: S Dosage Form: SOLUTION Applicant: DEY LABORATORIES INC Active Ingredient(s): ALBUTEROL SULFATE OTC/RX Status: RX Indication(s): For the treatment of asthma-related...
Cambridge Heart, Inc Dey L.P
Document Information Page page 1
author: David Hilfiker
[2000] [Open Forum] LEVALBUTEROL & ALBUTEROL SULFATE: A COMPARISON STUDY 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 -...
[2000] [Open Forum] DRUG DELIVERY OF HYDROFLUOROALKANE-ALBUTEROL SULFATE USING INLINE MDI ACTUATORS IN MECHANICALLY VENTILATED 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 -...
MiniHEART CONTINUOUS NEBULIZER ATTACHMENT FOR IN-LINE VENTILATOR AEROSOL MEDICATION DELIVERY 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®...
MiniHEART CONTINUOUS NEBULIZER ATTACHMENT FOR IN-LINE VENTILATOR AEROSOL MEDICATION DELIVERY Contact us -|- Sign in -|- U.S.A.albuterol was connected to the circuit wye with a 200 cc (24inches) corrugated tubing and a # 8...
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®...
Drug Approvals - D ANDA 40-480 9/9/03 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, Rx Abrika Pharmaceuticals ANDA 40-472 9/30/03 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, Rx Watson Laboratories ANDA 40-456 5/6/03 - - - Dextroamphetamine...
What's new at CDER by Date - U.SSulfate Ophthalmic Solution USP, Altana, Inc
author: Paul Stauffer
Prescription and Over-the-Counter Drug Product List: 1/2004 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETYLCYSTEINE >A> INJECTABLE; INTRAVENOUS >A> ACETADOTE >A> + CUMBERLAND PHARMS 6GM /30ML(200MG/ML) N21539 001 JAN 23, 2004 JAN NEWA ALBUTEROL SULFATE TABLET, EXTENDED RELEASE; ORAL ALBUTEROL SULFATE >D> AB PLIVA EQ 4MG BASE N76130 002 SEP 26, 2002 JAN CRLD >A> + EQ 4MG BASE N76130 002 SEP 26, 2002 JAN...
Drug Information Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Information about the- Products We Regulate New Prescription Drug Approvals Prescription Drug Information Major Drug Information Pages - Consumer Drug Information Over-the-Counter Drug Information Drug Safety & Side Effects Drug Preparedness and Bioterrorism Response Clinical Trials...
author: Carol Assouad
CDER Guidance Documents Posted 1/5/1998) Biopharmaceutics Bioanalytical Method Validation [ HTML ] or [ PDF ] (Issued 5/2001, Posted 5/22/2001) Bioavailability and Bioequivalence Studies for Orally Administered Drug Products - General Considerations [ Word ] or [ PDF ] (Issued 3/2003, Posted 3/19/2003) Cholestyramine Powder in Vitro Bioequivalence (Intermin Guidance) Clozapine Tablets in Vivo Bioequivalence...
Paragraph IV Patent Certifications - DRUG NAME DOSAGE FORM STRENGTH RLD Acetaminophen Extended-release Tablets 650 mg Tylenol Acetaminophen/ Aspirin/ Caffeine Tablets 250 mg/250 mg/ 65 mg Excedrin (migraine) Acetaminophen and Tramadol Hydrochloride Tablets 325 mg/ 37.5 mg Ultracet Acyclovir Sodium1 Injection 50 mg/mL, 10 mL and 20 mL vials Zovirax Albuterol Sulfate Oral Syrup 2 mg(base)/ 5 mL Ventolin ...
http://www.aerogen.com/pdf/scipres_accp_10-03.pdf The Role of Dose Volume in Delivering Albuterol Sulfate with a Low Residual Volume Nebulizer Fink JB, Simmons R, Aerogen, Inc., Mountain View, CA OBJECTIVE We wanted to determine the effect of initial drug volume on inhaled mass and time of administration with these low residual volume nebulizers
Aerogen News Evaluation of Three Small Volume Nebulizers for Use with Infant Ventilator Circuits scipres_aarc3_12-03.pdf 54kb - December 2003 Baby Don't Cry: In Vitro Comparison of "Baby's Breath" Aerosol Delivery Hood vs Face Mask or Blow-by Using the "SAINT" Infant Upper Airway Model and "Aeroneb Go" vs T-piece Nebulizer scipres_aarc2_12-03.pdf 1,314kb - December 2003 In Vivo Effect of Particle...
Aerogen News Evaluation of Three Small Volume Nebulizers for Use with Infant Ventilator Circuits scipres_aarc3_12-03.pdf 54kb - December 2003 Baby Don't Cry: In Vitro Comparison of "Baby's Breath" Aerosol Delivery Hood vs Face Mask or Blow-by Using the "SAINT" Infant Upper Airway Model and "Aeroneb Go" vs T-piece Nebulizer scipres_aarc2_12-03.pdf 1,314kb - December 2003 In Vivo Effect of Particle...
1997 Warning Letters and Notice of Violation Letters to Pharmaceutical Companies Food and Drug Administration • Center for Drug Evaluation and Research Compliance Activities Search Warning Letters and Untitled Letters to Pharmaceutical Companies 1997 These letters, sorted by month, are supplied by the CDER Freedom of Electronic Information OfficeAlbuterol Sulfate Inhalation Schering Corporation DDMAC 5...
1998 Warning Letters and Untitled Letters to Pharmaceutical Companies DDMAC 4/27 5/7 MUSE (alprostadil) urethral suppository Vivus DDMAC 4/1 4/9 Nicotrol Inhaler (nicotine) inhalation system McNeil Consumer Products DDMAC 4/6 4/16 Norvasc (amlodipine besylate) Tablets Pfizer Pharmaceuticals Group DDMAC 4/24 4/28 Oxistat (Oxiconazole Nitrate Cream) GlaxoWellcome DDMAC 5/19 5/29 Propecia (finasteride) Tablets Merck DDMAC 4/1 4/9 Serevent Diskus ...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt "ALBUTEROL SULPHATE AS MFGALBUTEROL SULFATE MANUFACTURED IN BOMBAY, INDIA." 6887 16-Mar-87 MEDICHEM SA AMOXAPINE AS MFGALBUTEROL INHALER) MFG
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls AMIODARONE HCL BAXTER ONCOLOGY GMBH IFOSFAMIDE GEDEON RICHTER LTD VINCRISTINE SULFATE FABBRICA ITALIANI SINTETICI SPA FUROSEMIDE DINAMITE DIPHARMA SPA TRIAMTERENE USP XIX/BP '73 DINAMITE DIPHARMA SPA CYPROHEPTADINE HCL, USP AVENTIS PHARMA SA PREDNISOLONE ACETATE NISSHIN FLOUR MILLING CO., LTDSULFATE ACRAF DAPIPRAZOLE (FORMERLY TRADINE) ORGAMOL SA...
http://www.fda.gov/cder/guidance/guidlist.pdf page 4
