Drug Approvals - B ANDA 65-022 2/27/02 - - - Baclofen Injection, 0.05mg/ml, Rx Medtronic Neurological NDA 20-075/S-019 1/17/03 1/23/03 - - Bacteriostatic Sodium Chloride Injection, 9%, Rx Abbott Laboratories NDA 18-800/S-014 2/19/03 7/9/03 - - Bacteriostatic Sodium Chloride Injection, 9%, Rx Abbott Laboratories NDA 18-800/S-011 5/16/03 - - - Bacteriostatic Sodium Chloride Injection, 9...
http://www.fda.gov/cder/orange/appendix_a.txt 45, DIHYDROERGOTAMINE MESYLATE DACARBAZINE, DACARBAZINE DALGAN, DEZOCINE DALMANE, FLURAZEPAM HYDROCHLORIDE DANAZOL, DANAZOL DANOCRINE, DANAZOL DANTRIUM, DANTROLENE SODIUM DAPSONE, DAPSONE DARANIDE, DICHLORPHENAMIDE DARAPRIM, PYRIMETHAMINE DARBID, ISOPROPAMIDE IODIDE DARICON, OXYPHENCYCLIMINE HYDROCHLORIDE DARVOCET A500, ACETAMINOPHEN DARVOCET, ACETAMINOPHEN DARVOCET-N 100,...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt SILVER SULFADIAZINE 4298 22-Oct-81 SCHERING PLOUGH AVONDALE CO DEXCHLORPHENIRAMINE MALEATE 4305 22-Oct-81 LOFTUS BRYAN CHEMICALS LTD CHLORPHENIRAMINE MALEATE 4312 21-Oct-81 SCHERING PLOUGH AVONDALE CO DEXBROMPHENIRAMINE MALEATE 4313 03-Nov-81 AVECIA INC "SDM 27 (10% NITROGLYCERIN IN PROPYLENE GLYCOL) MANUFACTURED IN TAMAQUA, PA." 4317 15-Oct-81 SCHERING PHARMACEUTICAL CORPORATION...
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls PROPRANOLOL HCL TIANJIN MEDICINES & HEALTH PRODUCTS IMPORT AND EXPORT CO METHOCARBAMOL MFG BY XIN XIN PHARMACEUTICAL MANUFACTORY SOCIETA ITALIANA CORTICOSTEROIDI SPA BETAMETHASONE VALERATE INDUSTRIA CHIMICA MILANESE SPA THIORIDAZINE HYDROCHLORIDE INDUSTRIA CHIMICA MILANESE SPA FLUPHENAZINE HcL MALLINCKRODT INC THALLOUS CHLORIDE TI 201 INDUSTRIA CHIMICA MILANESE SPA PERPHENAZINE...
http://www.paddocklabs.com/images/PadSec7-1.pdf page 5
ANDA Approvals - September 2003 - FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Approvals - September 2003 - ANDA Number Generic Drug Name Applicant Approval Date 1 76-220 OFLOXACIN TABLETS 200 MG, 300 MG, AND 400 MG - RANBAXY LABORATORIES LIMITED 9/2/2003- 2 76-093 OFLOXACIN TABLETS 200 MG, 300 MG, AND 400 MG - PAR PHARMACEUTICAL, INC
Prescription and Over-the-Counter Drug Product List: 9/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN >A> + MIKART 325MG/15ML;7.5MG/15ML N40482 001 SEP 25, 2003 SEP NEWA ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET; ORAL >A> OXYCODONE AND ACETAMINOPHEN >A> AA WATSON LABS 325MG;7.5MG N40535 001 SEP 05, 2003 SEP NEWA >A> AA 325MG;10MG...
author: AUTHOR
Prescription and OTC Drug Product List 8/2001 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST PRESCRIPTION DRUG PRODUCT LIST - 21ST EDITION ADDITIONS/DELETIONS FOR RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 8 - AUG 2001 ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL PHRENILIN WITH CAFFEINE AND CODEINE -A- AB AMARIN PHARMS 325MG;50MG;40MG;30MG N74911 001 AUG 22, 2001 AUG NEWA ACETAMINOPHEN;...
2003 Export Products List Alphabetical Page: 1 5760627132 pms- Acetaminophen 80mg/ 5mL Oral Solution 100mL Atasol / Tylenol / Tempra Analgesic / Antipyretic: As a non- salicylate analgesic- antipyretic for temporary relief of mild to moderate pain in a wide variety of conditions, including headache, earache, muscle strain, bursitis, sprains, menstrual cramps and musculoskeletal pain
author: Lee S. Ehler
2003 Export Products List Alphabetical page 6
author: Lee S. Ehler
2003 Export Products List Alphabetical page 5
author: Lee S. Ehler
Export Products List by System July 2003 page 40
author: Lee S. Ehler
Export Products List by System July 2003 page 37
author: Lee S. Ehler
SLA Products and information - Home » Products Printer Friendly Version DILTIAZEM PHENYLEPHRINE NICOTINE EPA BETHANECHOL 2% DILTIAZEM HYDROCHLORIDE CREAM Anal fissure is a tear in the skin of the back passage that causes pain
Useful Links - Home » Site Map Printer Friendly Version ---Site Map - ·- Overview THERAPEUTIC AREAS ·- Anal fissures ·- Ulcerative colitis ·- Haemorrhoids ·- Faecal incontinence ·- Crohn's disease ·- Pruritis ani - ·- Overview DILTIAZEM - ·- Topical 2% diltiazem in the treatment of chronic anal fissures
Guideline on Validation of the Limulus Amebocyte Lysate Test As An End-Product Endotoxin Text for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices at 56- 57oC) 3.00 mL Antirabies Serum 3.00 mL Antitoxin (Gas Gangrene) 3.00 mL Antivenom 3.00 mL Apommorphine HCl Tablets for Injection 0.09 mg Arginine HCl Injection 500.00 mg Ascorbic Acid 4.20 mg Asparaginase for Injection 1000.00 Iu Atracurium Besylate 0.50 mg Atropine Sulfate 0.09 mg Aurothioglucose Suspension 0.70 mg Azathioprine Sodium for Injection 5.00 mg Azlocillin 75.00 mg...
author: FDA / CBER
subject: December 1987 Guideline
Guideline on Validation of the Limulus Amebocyte Lysate Test As An End-Product Endotoxin Text for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices page 2
author: FDA / CBER
subject: December 1987 Guideline
http://www.paddocklabs.com/forms/secundum/volume_6_2.pdf The purpose of this study was to determine the physical and chemical stability of extemporaneous oral formulations of alprazolam, bethanechol chloride, chloroquine phosphate, cisapride, enalapril maleate, hydralazine hydrochloride, pyrazinamide, quinidine sulfate, rifampin and tetracycline hydrochloride, drugs commonly prescribed in oral liquid dosage formsBethanechol ...
http://www.paddocklabs.com/forms/secundum/volume_6_2.pdf page 2
http://www.paddocklabs.com/forms/secundum/volume_7_4.pdf Plastic Container Materials and Their Characteristics Polyethylene Polypropylene Polystyrene Polyvinyl Chloride HDPE LDPE Clarity Hazy, Hazy, Clear Clear Clear Transparent Translucent Water absorption Low Low Low Mod- High Low Water- vapor permeability Low Very low Very low High Low Oxygen Permeability High Mod- High Mod- High High Low CO 2 Permeabililty High Mod- High Mod-...
Sigma-RBI Handbook copy page 2
author: Diane Ward
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#:...
Generic Names of Some Trade Name Drugs, THE MERCK MANUAL OF HEALTH & AGING Committed to Providing Medical Information Table of Contents Index Enlarge Text Reset Text Shrink Text -- Buy the Book Learn about participating in clinical trials at this government website: www.clinicaltrials.gov - APPENDIX I - Drug Names: Generic and Trade TOPICS - Introduction -~ Some Trade Names of Generic Drugs -~ Generic Names of Some Trade Name Drugs - Generic Names of Some...
Some Trade Names of Generic Drugs, THE MERCK MANUAL OF HEALTH & AGING Committed to Providing Medical Information Table of Contents Index Enlarge Text Reset Text Shrink Text -- Buy the Book Learn about participating in clinical trials at this government website: www.clinicaltrials.gov - APPENDIX I - Drug Names: Generic and Trade TOPICS - Introduction -~ Some Trade Names of Generic Drugs-~ Generic Names of Some Trade Name Drugs - Some Trade Names of...
Gastroesophageal Reflux, Swallowing and Reflux Disorders, THE MERCK MANUAL OF HEALTH & AGING Committed to Providing Medical Information Table of Contents Index Enlarge Text Reset Text Shrink Text -- Buy the Book Learn about participating in clinical trials at this government website: www.clinicaltrials.gov - SECTION 3 Medical Conditions CHAPTER 54 - Swallowing and Reflux Disorders TOPICS - Introduction -~ Dysphagia -~ Gastroesophageal Reflux - Gastroesophageal Reflux In...
