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,...
EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2003 FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - - EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2003 (SE1 -SE7)* and EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2003 (SE8)* - GENERIC NAME APPLICANT NDA NUMBER SUPP TYPE SUPP NUMBER RECEIPT DATE APPROVAL DATE PRIORITY REVIEW TOTAL APPROVAL TIME (MONTHS) INDICATION/DESCRIPTION FLUOXETINE...
21227_Cancidas.htm Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Cancidas (Caspofungin Acetate) Injection Company:--Merck Research Laboratories Application No.:--21-227 Approval Date:-1/26/2001 - Approval Letter(s) - Printed Labeling - Medical Review(s) Part 1 - Part 2 Chemistry Review(s) - Pharmacology Review(s) Statistical Review...
author: Paul Stauffer
NDA Approvals for Calendar Year 2001 NDA APPROVALS FOR CALENDAR YEAR 2001 Updated through December 31, 2001 NDA NUMBER DRUG NAME GENERIC NAME APPLICANT/ SPONSOR CHEMICAL TYPE THERAPEUTIC CLASS APPROVAL DATE - 21-252 Canasa Mesalamine Axcan Scandipharm 5 P 05-Jan-01 21-208 Remeron SolTab Mirtazapine Organon 3 S 12-Jan-01 21-227 Cancidas Caspofungin Acetate Merck Research Labs 1 P 26-Jan-01 21-261...
author: Brenda Harmon
Efficacy Supplements Approved in Calendar Year 2002 (SE1-SE7 AND SE8s EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2002 (SE1 -SE7)* and EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2002 (SE8)* - GENERIC NAME APPLICANT NDA NUMBER SUPP TYPE SUPP NUMBER RECEIPT DATE APPROVAL DATE PRIORITY REVIEW- TOTAL APPROVAL TIME (MONTHS) INDICATION/DESCRIPTION ANASTROZOLE ASTRAZENECA 20-541 SE1 010 5-Mar-02 5-Sep-02 Y 6.0 Provides for the use of ARIMIDEX ...
author: Darlene Norris
Prescription and OTC Drug Product List 1/2001 Prescription and Over-the-Counter Drug Product List - 21st Edition Cumulative Supplement Number 1: January 2001 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE TABLET; ORAL TABLET; ORAL - ADD - ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE BISOPROLOL...
Candidiasis: Fungal Infections: 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...
Merck News Item Patients enrolled were men and women - age 16 years, who had received chemotherapy for malignancy or undergone HSCT, had documented neutropenia (absolute neutrophil count [ANC] -500/Aµl) for at least 96 hours that was not expected to recover within 48 hours, fever -38.0oC at randomization, and receivedA- - 96 hours of parenteral systemic antibacterial therapy before enrollment.A...
Product review Products 1 Aggrastat ® (tirofiban hydrochloride) •-In combination with heparin for treatment of acute coronary syndrome Arcoxia ® (etoricoxib) 2 •-Osteoarthritis •-Rheumatoid arthritis (in adults) •-Acute pain •-Chronic pain •-Dysmenorrhea (menstrual pain) •-Acute gouty arthritis Cancidas ® (caspofungin acetate) &...
Aspergillosis: Fungal Infections: 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...
BioPortfolio Limited World Market for Anti-Infectives, Volume I - Antifungals Chapter One: Executive Summary Introduction Scope and Methodology Size and Growth of the Market Issues and Trends Affecting the Market Leading Competitors Chapter Two: Introduction Fungal Infections Superficial Systemic Histoplasmosis Coccidioidomycosis Blastomycosis Demographics and Statistics Chapter Three: Systemic...
New Survey forecasts over 70% revenue growth in systematic antifungal market over the next decade Echinocandins to account for 22% of total sales by 2014 Novel antifungals, such as Cancidas (caspofungin), experienced relatively slow initial uptake, as physicians have been reluctant to use it without detailed, peer reviewed data.Cancidas has created increased competition within a sector traditionally dominated by a limited number of...
9344307 page 18
9344307 page 17
9344307 page 16
9344307 page 15
9344307 page 14
9344307 page 13
9344307 page 12
9344307 page 11
9344307 page 10
9344307 page 9
9344307 page 8
9344307 page 7
9344307 page 6
