Drug Approvals - B Product Name Company Application # Approval Date Letter Posted Label Posted Review Posted Bacitracin Injection, 50,000 units/vial, Rx American Pharmaceutical Partners ANDA 65-116 12/3/02 - - - Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment USP, Rx Altana, IncBlenoxane (bleomycin sulfate) Injection, USP, Rx Bristol...
1996 and Older - New Drug Application (NDA) New Drug Approval Packages These drug approval packages, sorted by product trade name, are supplied by the CDER Freedom of Electronic Information Office
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,...
RLD_LABELING_APPROVED_OCT_1999 Reference Listed Drug Labeling Approved in October 1999 Some of the product names below contain links to the approved labeling or the supplemental approval letter describing the specific changes.- Click on the product name to view the approved labeling changes in Adobe Acrobat format
FDA Drug Approvals List October 1999 Application #: 020156 Efficacy Supplement#: 022 Type: SE2 to Original New Drug Application Approval Date: 28-OCT-99 Trade Name: VIDEX Dosage Form: POWDER, FOR RECONSTITUTION Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE Active Ingredient(s): DIDANOSINE OTC/RX Status: RX Efficacy Claim:Provides for a new strength as well as allowing a change in dosing interval...
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...
DDPA February 1996 IT IS USEFUL IN THE DELINEATION OF REGIONS OF REVERSIBLE MYOCARDIAL ISCHEMIA IN THE PRESENCE OR ABSENCE OF INFARCTED MYOCARDIUM] 11-522 ADDERALL 10 RICHWOOD PHARM AMPHETAMINE ASPARTATE 13-FEB-96 (TABLET) FLORENCE, KY 2.5MG (SUPPL-010) 41042 AMPHETAMINE SULFATE 2.5MG DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINE SULFATE 2.5MG (AMPHETAMINE) 11-522 ADDERALL 20 RICHWOOD...
http://www.fda.gov/cder/da/ddpa93.wpd 74 207 NAPROXEN COPLEY NAPROXEN 02 26 93 (TABLET) CANTON, MA 250MG 02021 375MG 500MG (NONSTEROIDAL ANTI INFLAMMATORY) 19 715 DIPENTUM KABI OLSALAZINE SODIUM 01 05 93 (CAPSULE) PISCATAWAY, NJ 250MG 08855 (REVISED LABELING CLINICAL PHARMACOLOGY; PRECAUTIONS; ADVERSE REACTIONS) 09 218 COUMADIN DUPONT WARFARIN SODIUM 02 01 93 (TABLET) WILMINGTON, DE 1MG 19880 2MG 2.5MG 5MG 7.5MG 10MG ...
Hodgkin's Disease: Lymphomas: 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...
Ovarian Cancer: Cancers of the Female Reproductive System: 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...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, ABBOKINASE to BUTAZOLIDIN Trade Names of Some Commonly Used Drugs TRADE AND GENERIC NAMES OF COMMONLY USED DRUGS ABBOKINASE to BUTAZOLIDIN Trade Name Generic ABBOKINASE Urokinase ACCOLATE Zafirlukast ACCUPRIL Quinapril ACCUTANE Isotretinoin ACHROM YCIN V Tetracycline ACTHAR Corticotropin (ACTH) ACTIFED *Triprolidine ADALAT Nifedipine ADENOCARD Adenosine ADRIAMYCIN Doxorubicin ADVIL Ibuprofen AFRIN...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, Abciximab to Butorphanol Trade Names of Some Commonly Used Drugs GENERIC AND TRADE NAMES OF COMMONLY USED DRUGS Abciximab to Butorphanol Generic Trade Name Abciximab REOPRO Acarbose PRECOSE Acebutolol SECTRAL Acetaminophen TYLENOL Acetazolamide DIAMOX Acetohexamide DYMELOR Acetohydroxamic acid LITHOSTAT Acetophenazine TINDAL Acetylcysteine MUCOMYST ACTH See Corticotropin Acyclovir ZOVIRAX Adenosine ADENOCARD...
Bleomycin injection for warts - [Medication] - Quest Diagnostics Patient Health Library Bleomycin injection for warts Examples Brand Name Chemical Name Blenoxane bleomycin How It Works Bleomycin is an anticancer medication used to stop tumor growth.bleomycin injection is sometimes used to kill skin cells, effectively stopping wart growth.
Cell Cycle/DNA Transaction Compounds - - - Family view Cell Cycle/DNA Transaction Compounds Items 10-20 of 51 Page 2 of 6 Select page: << - 1 -2- 3 - 4 - 5 - 6 - >> - Prod
Bleomycin sulfate - ALX-630-107 - - For Pricing Information click here and submit your country
Toxins - - - Family view Toxins Items 1-10 of 80 Page 1 of 8 Select page: 1- 2 - 3 - 4 - 5 - 6 - 7 - 8 - 9 - >> - Prod
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, ABBOKINASE to BUTAZOLIDIN Trade Names of Some Commonly Used Drugs TRADE AND GENERIC NAMES OF COMMONLY USED DRUGS ABBOKINASE to BUTAZOLIDIN Trade Name Generic ABBOKINASE Urokinase ACCOLATE Zafirlukast ACCUPRIL Quinapril ACCUTANE Isotretinoin ACHROMYCIN V Tetracycline ACTHAR Corticotropin (ACTH) ACTIFED *Triprolidine ADALAT Nifedipine ADENOCARD Adenosine ADRIAMYCIN Doxorubicin ADVIL Ibuprofen AFRIN...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, Abciximab to Butorphanol Trade Names of Some Commonly Used Drugs GENERIC AND TRADE NAMES OF COMMONLY USED DRUGS Abciximab to Butorphanol Generic Trade Name Abciximab REOPRO Acarbose PRECOSE Acebutolol SECTRAL Acetaminophen TYLENOL Acetazolamide DIAMOX Acetohexamide DYMELOR Acetohydroxamic acid LITHOSTAT Acetophenazine TINDAL Acetylcysteine MUCOMYST ACTH See Corticotropin Acyclovir ZOVIRAX Adenosine ADENO...
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:...
RLD_LABELING_ APPROVED_AUG_1999 19-452 S-015 Hill Derm 18-Aug-1999 EULEXIN Flutamide Capsules 18-554 S-015 Schering 19-Aug-1999 MEPERGAN Meperidine HCl/Promethazine HCl 11-730 S-023 Wyeth Ayerst Labs 19-Aug-1999 ALDOCLOR-250 Methyldopa/Chlorthiazide Tablets 16-016 S-070 Merck 22-Aug-1999 INDERAL Propranolol HCl Tablets 16-418 S-071 Wyeth Ayerst Labs 22-Aug-1999 INDERAL Propranolol HCl Injection 16-419 S-022 Wyeth...
Microsoft Word - Approval.doc page 1
author: COTTRELLC
Microsoft Word - Approval.doc 1 BLENOXANE ® (bleomycin sulfate for injection, USP): Formerly known as: sterile bleomycin sulfate, USP DESCRIPTION BLENOXANE ® (bleomycin sulfate for injection, USP) is a mixture of cytotoxic glycopeptide antibiotics isolated from a strain of Streptomyces verticillus
author: COTTRELLC
Microsoft Word - Approval.doc page 11
author: COTTRELLC
Microsoft Word - Approval.doc page 9
author: COTTRELLC
Microsoft Word - Approval.doc page 8
author: COTTRELLC
