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,...
Drug Approvals - K Product Name Company Application # Approval Date Letter Posted Label Posted Review Posted Kaletra (lopinavir) oral solution, 80mg lopinavir/20mg ritonavirHydrochloride Injection USP, 50 mg, Rx Bioniche Pharma (Canada) Ltd
Prescription and Over-the-Counter Drug Product List: 7/2003 >A> @ FERRING 5,000 UNITS/VIAL N17055 001 JUL CAHN >A> @ 10,000 UNITS/VIAL N17055 002 JUL CAHN >A> @ 20,000 UNITS/VIAL N17055 003 JUL CAHN >D> @ WYETH AYERST 5,000 UNITS/VIAL N17055 001 JUL CAHN >D> @ 10,000 UNITS/VIAL N17055 002 JUL CAHN >D> @ 20,000 UNITS/VIAL N17055 003 JUL CAHN GRANISETRON HYDROCHLORIDE SOLUTION; ORAL KYTRIL >D> @ ROCHE EQ 2MG BASE/10ML N21238...
author: AUTHOR
NDA Approvals for Calendar Year 2001 Braun 5 S 21-Feb-01 21-235 Prozac Weekly Fluoxetine Hydrochloride Eli Lilly 3 S 26-Feb-01 21-169 Reminyl Galantamine Hydrobromide Janssen Research 1 S 28-Feb-01 21-082 Tavist Allergy/Sinus/Headache Acetaminophen/Clemastine Fumarate/Pseudoephedrine Hydrochloride Novartis 4 S 01-Mar-01 21-257 Travatan Travoprost Alcon 1 P 16-Mar-01 21-262 Alphagan P Brimonidine Tartrate...
author: Brenda Harmon
FDA Drug Approvals List June 2001 - Drug Approvals for June 2001 Definitions and Notes Original New Drug Applications Original Application #: 021288 Approval Date: 29-JUN-01 Trade Name: TRELSTAR Chemical Type: 3 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: DEBIO RECHERCHE PHARMACEUTIQUE SA Active Ingredient(s): TRIPTORELIN PAMOATE OTC/RX Status: RX Indication(s): For the palliative treatment of...
Prescription and OTC Drug Product List 6/2002 -D- + WYETH AYERST 20,000 UNITS/VIAL N17055 003 JUN DISC -A- @ 20,000 UNITS/VIAL N17055 003 JUN DISC CHORIONIC GONADOTROPIN -D- + STERIS 2,000 UNITS/VIAL N17016 011 FEB 16, 1990 JUN DISC -A- @ 2,000 UNITS/VIAL N17016 011 FEB 16, 1990 JUN DISC GRANISETRON HYDROCHLORID E SOLUTION; ORAL KYTRIL -D- + ROCHE EQ 2MG BASE/10ML N21238 001 JUN 27, 2001 JUN DISC -A- @ EQ 2MG BASE...
Efficacy Supplements Approved in Calendar Year 2002 (SE1-SE7 AND SE8s GRANISETRON HYDROCHLORIDE ROCHE 20-239 SE1 008 22-Oct-01 16-Aug-02- - 9.8 Provides for the use of KYTRIL (granisetron HCL) Injection for the prevention and treatment of postoperative nausea and vomiting
author: Darlene Norris
Prescription and OTC Drug Product List 6/1998 Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 6: June 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST - ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE CAPTOPRIL; HYDROCHLOROTHIAZIDE TABLET; ORAL TABLET; ORAL OXYCODONE AND ACETAMINOPHEN CAPOZIDE 25/15 - ADD - AA DURAMED 325MG;5MG N40272 001 - ADD - AB...
Drug Approvals for May 1997 orbiculare) Application #:020297Efficacy Supplement#:001 Type: SE1 to Original New Drug Application Approval Date: 29-MAY-97 Trade Name: COREG Dosage Form: TABLET Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS Active Ingredient(s): CARVEDILOL OTC/RX Status: RX Efficacy Claim: For the new indication of congestive heart failure and a new dosage strength of 3.125 mg Application #...
FDA Drug Approvals List Active Ingredient(s): NEDOCROMIL SODIUM OTC/RX Status: RX Efficacy Claim: Extending the approved use to the pediatric population of 6-11 years of age Approvable Original New Drug Applications Original Application #: 019781 Approvable Date: 31-MAR-97 Trade Name: PROMETRIUM Dosage Form: CAPSULE Applicant: SCHERING PLOUGH CORP Active Ingredient(s): PROGESTERONE OTC/RX Status: RX...
Drug Approvals January 1997 Drug Approvals for January 1997 Definitions and Notes January 1997 Original New Drug Applications Original Application #: 050733 Approval Date: 30-JAN-97 Trade Name: ZITHROMAX Chemical Type: 3 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: PFIZER INC Active Ingredient(s): AZITHROMYCIN OTC/RX Status: RX Indication(s): Treatment of patients with community-acquired...
DDPA November 1995 74-493 CAPTOPRIL PAR CAPTOPRIL 14-NOV-95 (TABLET) SPRING VALLEY, NY 12.5MG 10977 25MG 50MG 100MG (ANGIOTENSIN CONVERTING ENZYME INHIBITOR) ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 19-543 ELOCON SCHERING MOMETASONE FUROATE 03-OCT-95 (OINTMENT) KENILWORTH, NJ 0.1% 07033 (LABELING REVISION -- INDICATIONS AND USAGE; PRECAUTIONS; ADVERSE REACTIONS; DOSAGE AND ADMINISTRATION) 19-625...
Drug and Device Approvals March 1995 Drug and Device Approvals-March 1995 ***ORIGINAL AND SUPPLEMENTAL NDAs*** FOR NEW DRUG PRODUCTS 20-092 DILACOR XR RHONE POULENC RORER DILTIAZEM HYDROCHLORIDE 02-MAR-95 (CAPSULE, COLLEGEVILLE, PA 120MG (SUPPL-005)EXTENDED RELEASE) 19426 180MG 240MG (NEW INDICATION -- MANAGEMENT OF CHRONIC STABLE ANGINA) 20-281 ULTRAM JOHNSON RW TRAMADOL HYDROCHLORIDE 03-MAR-95 (TABLET)...
Drug Approvals for October 1997 Drug Approvals for October 1997 Definitions and Notes October 1997 Original New Drug Applications Original Application #: 020755 Approval Date: 31-OCT-97 Trade Name: CAVERJECT Chemical Type: 5 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: PHARMACIA AND UPJOHN CO Active Ingredient(s): ALPROSTADIL OTC/RX Status: RX Indication(s): Provides for an aqueous formulation for...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, GANTANOL to LYSODREN Trade Names of Some Commonly Used Drugs TRADE AND GENERIC NAMES OF COMMONLY USED DRUGS GANTANOL to LYSODREN Trade Name Generic GANTANOL Sulfamethoxazole GANTRISIN Sulfisoxazole GARAMYCIN Gentamicin GEOCILLIN Carbenicillin GLUCOPHAGE Metformin GLUCOTROL Glipizide GRIFULVIN V Griseofulvin GRISACTIN Griseofulvin HALCION Triazolam HALDOL Haloperidol HALDRONE Paramethasone HALOTESTIN...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, Factor IX concentrates to Itraconazole Trade Names of Some Commonly Used Drugs GENERIC AND TRADE NAMES OF COMMONLY USED DRUGS Factor IX concentrates to Itraconazole Generic Trade Name Factor IX concentrates KONYNE 80, PROPLEX T Famciclovir FAMVIR Famotidine PEPCID Felodipine PLENDIL Fenfluramine PONDIMIN Fenoprofen NALFON Fentanyl SUBLIMAZE Fexofenadine ALLEGRA Filgrastim NEUPOGEN Finasteride PROSCAR, PROPECIA Flavoxate...
Serotonin antagonists (5-HT3 receptor antagonists) - [Medication] - Quest Diagnostics Patient Health Library Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About Serotonin antagonists (5-HT3 receptor antagonists) - [Medication] - Quest Diagnostics Patient Health Library Serotonin antagonists (5-HT3 receptor antagonists) - [Medication] - Quest Diagnostics Patient Health Library Brain and nerves, Aloxi, anti-emetics, antiemetics,...
BioPortfolio Limited Commercial Insight: Cancer Market Top 20 Drugs - Supportive Care Grows the Cancer Market TABLE OF CONTENTS About Datamonitor Healthcare 2 CHAPTER 1 EXECUTIVE SUMMARY 3 CHAPTER 2 MARKET DEFINITION AND OVERVIEW 12 Scope 12 Market definition for this report 12 Cytotoxics 13 L1A – Alkylating agents 13 L1B – Antimetabolites 13 L1C – Vinca alkaloids and other plant products...
http://www.chugai-pharm.co.jp/pdf/annual_report/2003/AR03e_00.pdf page 14
author: ryo1
duplicates:http://www.chugai-pharm.co.jp/pdf/annual_report/2003/AR03e_06.pdf
http://www.chugai-pharm.co.jp/pdf/annual_report/2003/AR03e_00.pdf Epogin (epoetin beta) Agent for anemia associated with end- stage renal disease ¥62,700 ¥66,100 5.4% Alfarol (alfacalcidol) Agent for osteoporosis 20,000 17,900 Sigmart (nicorandil) Antianginal agent 15,600 15,500 Neutrogin (lenograstim) Agent for neutropenia associated with chemotherapy 14,200 13,700 Tamiflu (oseltamivir) Anti- influenza agent N 12,500 N Rythmodan ...
author: ryo1
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, GANTANOL to LYSODREN Trade Names of Some Commonly Used Drugs TRADE AND GENERIC NAMES OF COMMONLY USED DRUGS GANTANOL to LYSODREN Trade Name Generic GANTANOL Sulfamethoxazole GANTRISIN Sulfisoxazole GARAMYCIN Gentamicin GEOCILLIN Carbenicillin GLUCOPHAGE Metformin GLUCOTROL Glipizide GRIFULVIN V Griseofulvin GRISACTIN Griseofulvin HALCION Triazolam HALDOL Haloperidol HALDRONE Paramethasone HALOTESTIN...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, Factor IX concentrates to Itraconazole Trade Names of Some Commonly Used Drugs GENERIC AND TRADE NAMES OF COMMONLY USED DRUGS Factor IX concentrates to Itraconazole Generic Trade Name Factor IX concentrates KONYNE 80, PROPLEX T Famciclovir FAMVIR Famotidine PEPCID Felodipine PLENDIL Fenfluramine PONDIMIN Fenoprofen NALFON Fentanyl SUBLIMAZE Fexofenadine ALLEGRA Filgrastim NEUPOGEN Finasteride PROSCAR, PROPECIA Flavoxate...
1997 Warning Letters and Notice of Violation Letters to Pharmaceutical Companies Food and Drug Administration • Center for Drug Evaluation and Research Compliance Activities Search Warning Letters and Untitled Letters to Pharmaceutical Companies 1997 These letters, sorted by month, are supplied by the CDER Freedom of Electronic Information OfficeKytril (...
21-238_Kytril Oral Solution Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Kytril (Granisetron) Oral Solution Company:--Hoffmann-La Roche Inc
author: Paul Stauffer
Roche Selected Products Therapeutic Area Product Brand Name / Main Indication Indication Anesthesia and sedation Dormicum/Versed midazolam Cancer Furtulon doxifluridine Cancer of the colon Herceptin trastuzumab Breast cancer Kytril granisetron hydrochloride Cancer Mabthera/Rituxan rituximab Non-Hodgkin's lymphoma Roferon-A interferon alfa-2a Cancer Xeloda capecitabine Breast cancer...
