CDER Guidance Documents (Issued 8/2000, Posted 8/8/2000) Joint Safety/Efficacy (Multidisciplinary) (Draft) Submitting Marketing Applications According to the ICH/CTD Format: General Considerations (Issued 9/2001, Posted 9/5/2001) [ PDF ] M4 Common Technical Document--Quality: Questions and Answers/Location Issues [ HTML ] or [ PDF ] or [ ] (Issued 9/12/2002, Posted 12/30/2002) Quality Q1E Evaluation of...
http://www.fda.gov/cder/orange/appendix_a.txt 3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE #3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE, ACETAMINOPHEN ACETAMINOPHEN, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN AND CAFFEINE, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN, BUTALBITAL AND CAFFEINE, ACETAMINOPHEN ACETAMINOPHEN,...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt IN KALAMAZOO, MICH FACILS." 4797 31-Jan-83 DAIWA PHARMACEUTICAL CO LTD "CHLORZOXAZONE USP AS MANUFACTURED IN TOYAMA, JAPAN" 4798 22-Dec-82 SIFAVITOR SRL AMILORIDE HCL BP 80 4799 22-Nov-82 INDUSTRIA CHIMICA MILANESE SPA DEXBROMPHENIRAMINE MALEATE USPAMILORIDE HCL AS MFG
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls IN BUDAPEST, HUNGARY PLANTEX LTD CHEM AND PHARM WORKS IMIPRAMINE HYDROCHLORIDE LUNDBECK PHARMACEUTICALS ITALY SPA IMIPRAMINE HYDROCHLORIDE AVENTIS PHARMA SA PROMETHAZINE HCL GRUPPO LEPETIT SPA D-PROPOXYPHENE HYDROCHLORIDE BULK SCHERING AG ETHINYL ESTRADIOL ROCHE COLORADO CORPORATION
18-200s024_Midamor18-201s37 Food and Drug Administration • Center for Drug Evaluation and Research Title Search Midamor (Amiloride Hydrochloride) Tablets & Moduretic (Amiloride Hydrochloride & Hydrochlorothiazide) Tablets Company:--Merck & Co., Inc
author: USERNAME
FDA Drug Approvals List September 2001 - Drug Approvals for September 2001 Definitions and Notes Original New Drug Applications Original Application #: 021279 Approval Date: 25-SEP-01 Trade Name: FORADIL Chemical Type: 3 Therapeutic Potential: S Dosage Form: POWDER, FOR INHALATION Applicant: NOVARTIS PHARMACEUTICALS CORP Active Ingredient(s): FORMOTEROL FUMARATE OTC/RX Status: RX Indication(s): For the long-term, twice...
FDA Drug Approvals List March 2002 - Drug Approvals for March 2002 Definitions and Notes Original New Drug Applications Original Application #: 020855 Approval Date: 21-MAR-02 Trade Name: MESNA Chemical Type: 3 Therapeutic Potential: S Dosage Form: TABLET Applicant: ASTA MEDICA AG Active Ingredient(s): MESNA OTC/RX Status: RX Indication(s): For the use as a prophylactic agent in reducing the incidence of ifosfamide...
MODURET Product Monograph Amiloride Hydrochloride Amiloride hydrochloride is an antikaliuretic drug with mild natriuretic diuretic and antihypertensive activityAmiloride Hydrochloride Amiloride hydrochloride is chemically unrelated to other known antikaliuretic or diuretic agentsAmiloride hydrochloride increases the Na+/ K+ excretion ratio in adrenalectomized...
author: Merck Frosst Canada & Co.
subject: 675-a,10,00
MODURET Product Monograph page 11
author: Merck Frosst Canada & Co.
subject: 675-a,10,00
MODURET Product Monograph page 10
author: Merck Frosst Canada & Co.
subject: 675-a,10,00
MODURET Product Monograph page 1
author: Merck Frosst Canada & Co.
subject: 675-a,10,00
withdrawn.PDF page 2
author: walshju
SSCI Inc.: X-ray Powder Diffraction, Raman and Infrared Spectroscopy, Differential Scanning Calorimetry, and Thermogravimetric Phone: 800 375-2179 / 765 463-0112 Fax: 765 497-2649 / 765 463-4722 E-mail: info@ssci-inc.com SSCI Inc., 3065 Kent Avenue, West Lafayette, IN 47906 - 1076 USA Acetaminophen Acetazolamide Acetohexamide Acetylcysteine Acyclovir Adenine L-Alanine Albuterol Albuterol Sulfate Allopurinol Alprazolam Amantadine HCl Amiloride HCl Aminobenzoic Acid Aminoglutethimide Aminosalicylic Acid...
author: SSCI Webmaster
CDER Guidance Documents (Issued 8/2000, Posted 8/8/2000) Joint Safety/Efficacy (Multidisciplinary) (Draft) M2 Electronic Common Technical Document Specification [ HTML ] or [ PDF ] (Issued 6/2002, Posted 6/13/2002) Submitting Marketing Applications According to the ICH/CTD Format: General Considerations (Issued 9/2001, Posted 9/5/2001) [ PDF ] M4 Common Technical Document--Quality: Questions and Answers...
Comprehensive List of Current Guidance Documents at the Food and Drug Administration page 36
author: FDA
Comprehensive List of Current Guidance Documents at the Food and Drug Administration page 27
author: FDA
Quarterly List of Guidance Documents at the Food and Drug Administration page 12
author: FDA
Annual Comprehensive List of Guidance Documents at the Food and Drug Administration page 31
author: FDA
subject: 7/21/2000
Prescription and OTC Drug Product List 8/1998 Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 8: August 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE TABLET; ORAL TABLET; ORAL - ADD - BUTALBITAL, ACETAMINOPHEN AND CAFFEINE MODURETIC 5-50 - ADD - AB...
http://www.fda.gov/cber/gdlns/guidelst.txt Drug Advertising and Promotional Labeling DDMAC 2 Dissemination of Reprints of Certain October 8, 1996 Advertising Do Published, Original Data Funded Dissemination of Reference October 8, 1996 Do Do Texts Antifungal (topical) February 24, 1990 Biopharmaceutic Drug Information Branch (Draft) Antifungal (vaginal) February 24, 1990 Do Do Food-Effect Bioavailability and December 30, 1997...
http://www.fda.gov/cber/gdlns/anguidlst.txt Preliminary Guidance -------------------------------------------------------------------------------------------------------------------------------------------------------- Implementation Plan USP injection nomenclature October 2, 1995 Do Do -----------------------------------------------------------------------------------------------------------------------------------------------...
http://www.plantsci.cam.ac.uk/plantsci/admin/forms/ChemCategABC.pdf page 1 DEPARTMENT OF PLANT SCIENCES, University of Cambridge CONTROL OF SUBSTANCES HAZARDOUS TO HEALTH (1988) REGULATIONS Chemical Inventory (A, B, C ) Classified Laboratory Chemicals (Categories A, B and C on Experimental Risk Assessment form) The chemicals listed below have been classified as Category ...
FDA Drug Approvals List- August 1998 Approvable Original New Drug Applications Original Abbreviated New Drug Applications Original Abbreviated Application # 074951 Approval Date: 31-AUG-98 Trade Name: BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE Dosage Form: CAPSULE Applicant: JEROME STEVENS PHARMACEUTICALS INC Active Ingredient(s): ASPIRIN; BUTALBITAL; CAFFEINE; AND CODEINE PHOSPHATE OTC/RX Status: RX Original...
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...
