Drug Approvals - D
ANDA 75-371 8/27/99 9/2/99 - - Dacarbazine for Injection USP, 200 mg/vial, Rx Gensia Sicor Pharmaceuticals ANDA 75-259 8/27/98 9/2/98 - - Dalmane (flurazepam hydrochloride) Capsules, 15 mg and 30 mg ICN Pharmaceuticals NDA 16-721/S-074 6/14/01 11/22/02 Daraprim (pyrimethamine) Tablets, 25 mg, Rx GlaxoSmithKline NDA 8-578/S16 11/18/03 11/25/03 12/1/03 - Daraprim (pyrimethamine)...
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...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt
FACILITIES" 5202 03-Jan-84 PHARMACIA AND UPJOHN INC "DINOPROSTONE SYNTHETIC (BULK) MFG KALAMAZOO, MI FACILITIES (PORTAGE RD" 5204 22-Dec-83 LUDWIG HEUMANN AND CO GMBH TAMOXIFEN CITRATE 5208 09-Jan-84 FABBRICA ITALIANA SINTETICI "OXAZEPAM,BULK FORM AS PRODUCED IN THE VICENZA FACILITIES" 5223 16-Dec-83 FABBRICA ITALIANI SINTETICI SPA "TEMAZEPAM, BULK FORM" 5238 16-Feb-84 DYNAMIT NOBEL...
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls
FACILITIES PHARMACIA AND UPJOHN INC DINOPROSTONE SYNTHETIC (BULK) MFG KALAMAZOO, MI FACILITIES (PORTAGE RD LUDWIG HEUMANN AND CO GMBH TAMOXIFEN CITRATE FABBRICA ITALIANA SINTETICI OXAZEPAM,BULK FORM AS PRODUCED IN THE VICENZA FACILITIES FABBRICA ITALIANI SINTETICI SPA TEMAZEPAM, BULK FORM DYNAMIT NOBEL AKTIENGESELLESCHAFT NITROGLYCERINE 10% IN LACTOSE ORGAMOL SA CARISOPRODOL FINE...
FDA Drug Approvals List June 2001
PERRIGO COMPANY Active Ingredient(s): MONOXIDIL OTC/RX Status: RX Original Abbreviated Application # 075750 Approval Date: 8-JUN-01 Trade Name: DOXAZOSIN MESYLATE Dosage Form: TABLET Applicant: SIDMAK LABORATORIES, INC Active Ingredient(s): DOXAZOSIN MESYLATE OTC/RX Status: RX Original Abbreviated Application # 075502 Approval Date: 05-JUN-01 Trade Name: CLOTRIMAZOLE AND...
Prescription and OTC Drug Product List 7/2001
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, ACETAMINOPHEN AND CAFFEINE -A- AB ABLE 325MG;50MG;40MG N40390 001 JUL 23, 2001 JUL NEWA -A- AB 500MG;50MG;40MG N40394 001 JUL 23, 2001 JUL NEWA ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -D- AA + WATSON LABS 325MG;7.5MG...
Comprehensive List of Current Guidance Documents at the Food and Drug Administration page 29
author: FDA
Quarterly List of Guidance Documents at the Food and Drug Administration page 12
author: FDA
http://www.medvet.com.au/downloads/drg_scr/sitescreen_product_insert.pdf
M e t h a d o n e: Methadone is a synthetic analgesic drug that is originally used in the treatment of narcotic addicts. Among the psychological effects induced by using methadone are analgesia, sedation and respiratory depression. Overdose of methadone may cause coma or even death. It is administered ...
http://www.medvet.com.au/downloads/drg_scr/sitescreen_product_insert.pdf page 2
PERFORMANCE CHARACTERISTICS A. Accuracy For each individual drug screen assay, approximately 60 urine samples of specific drugs were obtained form clinical laboratories. The concentration of drug present in the samples was determined by either GC/ MS or commercial kits. Each sample was then ...
Prescription and OTC Drug Product List 11/1998
Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 11: November 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE CLOBETASOL PROPIONATE TABLET; ORAL OINTMENT; TOPICAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN EMBELINE - ADD - ENDO PHARMS 400MG;5MG N40288 001 - ADD - AB...
PDPL
- ADD - + ADV MAGNETICS EQ 11.2MG IRON/ML N20416 001 ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE - ADD - AUG 30, 1996 TABLET; ORAL-21 ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL 1/35-21 FLUPHENAZINE DECANOATE - DLT - AB WATSON LABS 0.035MG;1MG N72720 001 - DLT - DEC 30, 1991 INJECTABLE; INJECTION ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL 1/50-21 FLUPHENAZINE DECANOATE - DLT - AB WATSON...
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...
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...
Index F, 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 - INDEX - Index-A -~ Index-B -~ Index-C -~ Index-D -~ Index-E -~ Index-F-~ Index-G -~ Index-H -~ Index-I -~ Index-J -~ Index-K -~ Index-L -~ Index-M -~ Index-N -~ Index-O ...
Anxiety, Mental Health 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 32 - Mental Health Disorders TOPICS - Introduction -~ Depression -~ Anxiety-~ Psychosis - Anxiety Anxiety is intense nervousness or...
Insomnia, Sleep, 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 31 - Sleep TOPICS - Introduction -~ Insomnia-~ Excessive Daytime Sleepiness -~ Limb Movement Disorders -~ Sleep Apnea -~ REM Sleep...
Introduction, Dementia, 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 27 - Dementia TOPICS - Introduction-~ Alzheimer's Disease -~ Vascular Dementia -~ Lewy Body Dementia - Introduction Dementia is a...
Drugs and Aging, 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 2 Caring for Self and Others CHAPTER 6 - Drugs and Aging TOPICS - Drugs and Aging - Drugs and Aging When people get older, they tend to use more drugs. On the...
Genetic Makeup: Factors Affecting Response to Drugs: Merck Manual Home Edition
Section Drugs Subject Factors Affecting Response to Drugs Genetic Makeup Differences in genetic (inherited) makeup among individuals affect what the body does to a drug and what the drug does to the body. Other people metabolize drugs so quickly that after they take a usual dose, drug levels in the blood never become high enough for the drug to be effective. In about half of...
Urinary Incontinence: Merck Manual Home Edition
Drugs That May Cause or Worsen Urinary Incontinence Type of Drug Examples Effects Alcohol Wine, beer, liquor Increases urine production Alpha-adrenergic agonists Nasal decongestants (containing pseudoephedrine) Tighten the urinary sphincter; can cause urinary retention and overflow incontinence Alpha-adrenergic blockers Prazosin, terazosin, doxazosin, tamsulosin Relax the bladder...
Insomnia: Sleep Disorders: Merck Manual Home Edition
Section Brain, Spinal Cord, and Nerve Disorders Subject Sleep Disorders Insomnia Insomnia is difficulty falling asleep or staying asleep or a disturbance in sleep that makes sleep seem inadequate or unrefreshing. These changes are normal and usually do not indicate a sleep disorder. Symptoms and Diagnosis Symptoms include irritability, fatigue during the day, and problems...
Aging and Drugs: Merck Manual Home Edition
Section Drugs Subject Aging and Drugs Aging and Drugs Older people tend to take more drugs than younger people because they are more likely to have several, often chronic disorders. Also, other, safer drugs can often be substituted. Not following a doctor's directions for taking a drug (noncompliance or nonadherence) can be risky (see Compliance With Drug Treatment:...
Genetic Makeup: Factors Affecting Response to Drugs: 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...