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 Albuterol...
http://www.fda.gov/cder/orange/appendix_a.txt ACTHAR GEL, CORTICOTROPIN H.R.-50, HYDROCHLOROTHIAZIDE HABITROL, NICOTINE (OTC) HALCION, TRIAZOLAM HALDOL SOLUTAB, HALOPERIDOL HALDOL, HALOPERIDOL HALDOL, HALOPERIDOL DECANOATE HALDOL, HALOPERIDOL LACTATE HALDRONE, PARAMETHASONE ACETATE HALFAN, HALOFANTRINE HYDROCHLORIDE HALOG, HALCINONIDE HALOG-E, HALCINONIDE HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE HALOPERIDOL INTENSOL,...
Prescription and Over-the-Counter Drug Product List: 5/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, APAP, AND CAFFEINE -A- AB AXIOM PHARM 325MG;50MG;40MG N89536 001 FEB 16, 1988 MAY CAHN -D- AB HALSEY 325MG;50MG;40MG N89536 001 FEB 16, 1988 MAY CAHN ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -A- AA ABLE 500MG;7.5MG...
author: AUTHOR
Prescription and Over-the-Counter Drug Product List: 3/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL FIORICET W/ CODEINE -D- AB + NOVARTIS 325MG;50MG;40MG;30MG N20232 001 JUL 30, 1992 MAR CAHN -A- AB + WATSON PHARMS 325MG;50MG;40MG;30MG N20232 001 JUL 30, 1992 MAR CAHN ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL CODRIX -A- + ANDRX PHARMS 500MG;30MG N40441 001...
author: AUTHOR
Prescription and OTC Drug Product List 8/2001 ACTHAR GEL -D- BC + AVENTIS 40 UNITS/ML N08372 006 FEB 06, 1956 AUG CAHN -D- BC + 80 UNITS/ML N08372 008 FEB 06, 1956 AUG CAHN -A- BC + QUESTCOR PHARMS 40 UNITS/ML N08372 006 FEB 06, 1956 AUG CAHN -A- BC + 80 UNITS/ML N08372 008 FEB 06, 1956 AUG CAHN DELAVIRDINE MESYLATE TABLET; ORAL RESCRIPTOR -D- + AGOURON 100MG N20705 001 APR 04, 1997 AUG CRLD -A- 100MG N20705 001 APR 04, 1997 AUG...
2003 Export Products List Alphabetical page 28
author: Lee S. Ehler
http://www.fda.gov/cder/foi/label/2001/19059s17lbl.pdf page 2
http://www.fda.gov/cder/foi/label/2001/19059s17lbl.pdf page 1
H:\PM Folder\NDA ltrs\18031s30n19059s16ap.doc page 2
author: Zelda McDonald
H:\PM Folder\NDA ltrs\19059s17n18031s31.doc page 1
author: Daryl L. Allis
Prescription and OTC Drug Product List 9/1999 Prescription and Over-the-Counter Drug Product List - 19th Edition Cumulative Supplement Number 9: September 1999 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE ATENOLOL CAPSULE; ORAL TABLET; ORAL - DLT - BUTALBITAL, ACETAMINOPHEN, CAFFEINE ATENOLOL - DLT - AB GRAHAM DM 325MG;50MG;40MG N88758 001 - ADD - MYLAN 25MG...
FDA Drug Approvals List August 1999 Approvable Original New Drug Applications Original Application #: 021037 Approvable Date: 26-AUG-99 Trade Name: MAGNEVIST Dosage Form: INJECTABLE Applicant: BERLEX LABORATORIES INC Active Ingredient(s): GADOPENTETATE DIMEGLUMINE OTC/RX Status: RX Original Application #: 020989 Approvable Date: 27-AUG-99 Trade Name: EVOXAC Dosage Form: CAPSULE Applicant: SNOWBRAND PHARMACEUTICALS INC...
Drug Approvals for November 1997 Drug Approvals for November 1997 Definitions and Notes November 1997 Original New Drug Applications Original Application #: 020652 Approval Date: 26-NOV-97 Trade Name: TESLASCAN Chemical Type: 1 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: NYCOMED INC Active Ingredient(s): MANGAFODIPIR TRISODIUM OTC/RX Status: RX Indication(s): As an adjunct to MRI to enhance the T1...
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...
Site Selectivity: Dynamics of Drugs: Merck Manual Home Edition Beta-blockers, such as propranolol Some Trade Names INDERAL , are a widely used group of antagonists.
Tremor: Movement Disorders: 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...
Portal Hypertension: Clinical Manifestations of Liver Disease: 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...
Atrial Fibrillation and Atrial Flutter: Abnormal Heart Rhythms: 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...
Heart Attack: Coronary Artery Disease: 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...
Migraines: Headaches: Merck Manual Home Edition Beta-blockers, such as propranolol Some Trade Names INDERAL , are often given first.Propranolol - - Calcium channel blockers Verapamil - - Serotonin blockers Methysergide Formation of scar tissue deep within the abdomen (retroperitoneal...
Functional Peripheral Arterial Disease: Peripheral Arterial Disease: 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...
Parkinson's Disease: Movement Disorders: 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...
Bartter's Syndrome: Tubular and Cystic Kidney Disorders: 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...
Drug Interactions: 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...
Heart Defects: Birth Defects: 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...
