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,...
OGD, First Time Approvals - May 2002 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search First-Time Generics - May 2002 Generic Drug Name Generic Manufacturer Brand Name Approval Date 1- IDARUBICIN HYDROCHLORIDE FOR INJECTION, USP 5 MG, 10 MG, AND 20 MG SINGLE-DOSE VIALS GENSIA SICOR PHARMACEUTICALS, INCIDAMYCIN FOR INJECTION 5/1/02 2- AMMONIUM...
author: OGD
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/10ML N21238...
Prescription and OTC Drug Product List 5/2002 2 -D- + ROBINS AH 325MG;15MG N84444 001 MAY DISC -A- @ 325MG;15MG N84444 001 MAY DISC SOLUTION; ORAL ACETAMINOPHEN AND CODEINE PHOSPHATE -D- AA ALPHARMA 120MG/5ML;12MG/5ML N85861 001 MAY CRLD -A- AA + 120MG/5ML;12MG/5ML N85861 001 MAY CRLD TYLENOL W/ CODEINE -D- AA + JOHNSON RW 120MG/5ML;12MG/5ML N85057 001 MAY DISC -A- @ 120MG/5ML;12MG/5ML N85057 001 MAY DISC TABLET; ORAL...
FDA Drug Approvals List- April 1998 Application #: 020555 Efficacy Supplement#: 003 Type: SE1 to Original New Drug Application Approval Date: 01-APR-98 Trade Name: AXID AR Dosage Form: TABLET Applicant: WHITEHALL ROBINS HEALTHCARE Active Ingredient(s): NIZATIDINE OTC/RX Status: OTC Efficacy Claim: Provides for treatment of episodic heartburn, acid indigestion and sour stomach Application #: 020393 Efficacy Supplement#:...
February Drug Approvals Drug Approvals for February 1997 Definitions and Notes February 1997 Original New Drug Applications Original Application #: 020723 Approval Date: 27-FEB-97 Trade Name: ALDARA Chemical Type: 1 Therapeutic Potential: S Dosage Form: CREAM Applicant: 3M PHARMACEUTICALS INC Active Ingredient(s): IMIQUIMOD OTC/RX Status: RX Indication(s): Treatment of external genital and perianal warts...
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...
Acute Myelocytic Leukemia: Leukemias: 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...
Idarubicin - [Medication] - Quest Diagnostics Patient Health Library Idarubicin Examples Brand Name Chemical Name Idamycin Idarubicin Idarubicin is an intravenous (IV) medication.Idarubicin is used to treat acute myelogenous leukemia (AML).Idarubicin is an effective antitumor medication.Idarubicin, when used with cytosar, induced a complete remission in people with...
Cancer.gov - Nausea and Vomiting (PDQ®) The American Society of Clinical Oncology (ASCO) has developed a rating system for chemotherapeutic agents and their respective risk of acute and delayed emesis.[ 1 ] High-risk cisplatin: Emesis that has been documented to occur in more than 99% of patients: cisplatin (Platinol) High-risk noncisplatin: Emesis that has been documented to occur in 30% to greater than 90% of patients:...
ASCO/FDA Lung Cancer Endpoints Workshop: Final Summary FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER American Society of Clinical Oncology/FDA Lung Cancer Endpoints Workshop April 15, 2003 [The following comments reflect the opinions of the workshop participants and do not necessarily represent the views of the FDA] Introductory Remarks Dr
ASCO/FDA Lung Cancer Endpoints Workshop 4/15/03 CDER USER ASCO/FDA Lung Cancer Endpoints Workshop 4/15/03 _ * o * * o * * o * * o * * o * * o * * o * * o * * o * * o * * o * * o * * o * * o * * o * * o * * o * * o * * o * * o * * o * - o * * o * * o * * o * * o * * o * - o * * o * * o * 12/9/2003 ASCO/FDA Lung Cancer Endpoints Workshop DRAFT 10/8/03 ASCO/FDA Lung Cancer Endpoints Workshop April 15, 2003 [The following comments...
RLD_LABELING_ APPROVED_AUG_1999 Product Name Drug Name NDA No Supp.No Firm Date LARIAM Mefloquine HCl Tablets 19-591 S-012 Roche 02-Aug-1999 PROSCAR Finasteride Tablets 20-180 S-018 Merck 02-Aug-1999 CEFOTAN Cefatetan Disodium 50-588 S-026 Zeneca 05-Aug-1999 MARINOL Dronabinol Capsules 18-651 S-011 Unimed 05-Aug-1999 ZOCOR Simvastatin Tablets 19-766 S-032 Merck 05-Aug-1999 GLUCOTROL Glipizide Tablets 17-783 S-015...
http://www.fda.gov/cder/foi/label/2003/50734slr005_idamycin_lbl.pdf It is recommended that IDAMYCIN PFS be administered only under the supervision of a physician who is experienced in leu emia chemotherapy and in facilities with laboratory and supportive resources adequate to monitor drug tolerance and protect and maintain a patient compromised by drug toxicityIDAMYCIN PFS Injection...
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http://www.fda.gov/cder/foi/appletter/2003/50734slr005ltr.pdf DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 NDA 50- 734/ S- 005 Pharmacia and Upjohn Corporation 1425 Route 206 South, Mailstop 024 Bedminster, NJ 07921 Attention: Lynne Fahey McGrath, MPH, Ph
author: SPILLMAND
http://www.fda.gov/cder/foi/appletter/2003/50734slr005ltr.pdf page 1
author: SPILLMAND
C:\data\My Documents\PENDING\Nimby\BAtkins\N50-661-slr007-ap-ltr.d\ oc DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville MD 20857 NDA 50- 661/ S- 007 Pharmacia & Upjohn Company Unit 0633- 298- 113 7000 Portage Road Kalamazoo, MI 49001 Attention: Gregory A
author: Dianne Spillman
C:\data\My Documents\PENDING\Nimby\BAtkins\N50-661-slr007-ap-ltr.d\ oc page 1
author: Dianne Spillman
C:\data\My Documents\PENDING\Nimby\BAtkins\N50-661-slr008-ap-ltr.d\ oc DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 NDA 50- 661/ S- 008 Pharmacia & Upjohn Company Unit 0633- 298- 113 7000 Portage Road Kalamazoo, MI 49001 Attention: Gregory A
author: Dianne Spillman
C:\data\My Documents\PENDING\Nimby\BAtkins\N50-661-slr008-ap-ltr.d\ oc page 1
author: Dianne Spillman
Cancer Care Ontario Formulary Information for patients, health professionals and public on cancer prevention, screening, treatment (radiation, chemotherapy, surgery), supportive care, research, education, and standards and guidelines ...
http://www.cancercare.on.ca/formulary/pdfmedicationinfo/Idarubicin.pdf For more information on this medication, please call your doctor or nurse, or the Cancer Centre Drug Information pharmacist. MEDICATION INFO SHEET IDARUBICIN (eye- da- RUE- bi- sin) Other Names for this Medication: Idamycin (Brand Name) Appearance: Injection: Red- orange coloured solution for ...
