Drug Approvals - A This newly approved or tentatively approved drug listing is an interim page intended to provide timely information on new drug products as a more comprehensive page is developed
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,...
Prescription and Over-the-Counter Drug Product List: 9/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN >A> + MIKART 325MG/15ML;7.5MG/15ML N40482 001 SEP 25, 2003 SEP NEWA ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET; ORAL >A> OXYCODONE AND ACETAMINOPHEN >A> AA WATSON LABS 325MG;7.5MG N40535 001 SEP 05, 2003 SEP NEWA >A> AA 325MG;10MG...
author: AUTHOR
Prescription and Over-the-Counter Drug Product List: 7/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE TABLET; ORAL PROPOXYPHENE HCL AND ACETAMINOPHEN >A> AA VINTAGE PHARMS 650MG;65MG N40507 001 JUL 30, 2003 JUL NEWA ACYCLOVIR TABLET; ORAL ACYCLOVIR >D> AB CLONMEL HLTHCARE 400MG N74834 001 APR 24, 1997 JUL DISC >A> @ 400MG N74834 001 APR 24, 1997 JUL DISC >D> AB 800MG N74834 002 APR 24,...
author: AUTHOR
http://www.fda.gov/cder/ogd/rld/RLD_LABELING_APPROVED_JAN_1999.HTML 20-869 001 Merck Res 4-Jan-1999 LESCOL Fluvastatin Sodium Capsule 20-261 019 Novartis Pharm 4-Jan-1999 CORDARONE Amiodarone Hydrochloride Tablets 200 mg 18-972 017 Wyeth Ayerst Labs 5-Jan-1999 LAMISIL Terbinafine HCl Tablets 20-539 003 Novartis Pharms 5-Jan-1999 LOESTRIN FE 1.5/30 Ethinyl Estradiol/Norethindrone Tablets 17-355 043 Parke Davis 8-Jan-1999 LOESTRIN FE 1/20 Ethinyl...
FDA Drug Approvals List March 2002 - Drug Approvals for March 2002 Definitions and Notes Original New Drug Applications Original Application #: 020855 Approval Date: 21-MAR-02 Trade Name: MESNA Chemical Type: 3 Therapeutic Potential: S Dosage Form: TABLET Applicant: ASTA MEDICA AG Active Ingredient(s): MESNA OTC/RX Status: RX Indication(s): For the use as a prophylactic agent in reducing the incidence of ifosfamide...
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...
FDA Drug Approvals List- January 1999 Drug Approvals for January 1999 Definitions and Notes January 1999 Original New Drug Applications Original Application #: 020781 Approval Date: 27-JAN-99 Trade Name: ZOFRAN ODT Chemical Type: Therapeutic Potential: Dosage Form: TABLET Applicant: GLAXO WELLCOME INC Active Ingredient(s): ONDANSETRON OTC/RX Status: RX Indication(s): For the prevention of chemotherapy and radiation...
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...
Drug Approvals for September 1997 The development of multiple follicles in the ovulatory patient participating in an Assisted Reproductive Technology (ART) program Original Application #: 020857 Approval Date: 26-SEP-97 Trade Name: COMBIVIR Chemical Type: 4 Therapeutic Potential: P Dosage Form: TABLET Applicant: GLAXO WELLCOME INC Active Ingredient(s): LAMIVUDINE; ZIDOVUDINE OTC/RX Status: RX Indication(s): Treatment...
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,...
biovista.com : biotechnology companies Box 9627 Post Code: Kansas City, MO 64134-0627 Tel: 888-242-9321 Fax: Web Site: www.hmri.com People: Products: Allegra® (fexofenadine HCl) Allegra-D™ (fexofenadine), Altace® (ramipril), Amaryl® (glimepiride tablets), Anzemet ® Tablets (dolasetron mesylate), Anzemet ® Injection (dolasetron mesylate injection), Carafate® ...
author: genesis studios, http://www.genesis-studios.cc
Aloxi Consumer Information Aloxi® Brand Name: Aloxi® Active Ingredient: - p alonosetron Strength(s): 0.25 mg in 5 mL Dosage Form(s): - Injection Availability: ------- Prescription only Company Name: -- Helsinn Healthcare *Date Approved by FDA: July 25, 2003 *Approval by FDA does not mean that the drug is available to consumers at this time
Reference Listed Drug Labeling Approved in March 2002 Approval Date Product Name Active Ingredient(s) Dosage Form NDA No Supp No Mar 1 BICILLIN C-R letter - penicillin G benzathine/ procaine injection 50-138 S-219 - BICILLIN L-A letter - penicillin G benzathine/ procaine injection 50-141 S-215 - COLY-MYCIN S letter - colistin & neomycin sulfates/thonzonium Br /hydrocortisone acetate otic suspension 50-356 S-045 - CUROSURF letter label...
author: USERNAME
Abbott to spin-off hospital products business Abbott will retain the following proprietary pharmaceuticals, including related portions of the international hospital business: hospital operating room pharmaceuticals, such as Ultane/Sevorane (sevoflurane), Anzemet (dolasetron mesylate injection) and proprietary neuromuscular blockers; hospital pharmaceuticals such as Calcijex (calcitriol injection), Zemplar ...
C:\Data\My Documents\Supplements\20624603.1.doc page 1
author: Brian Strongin
C:\Data\My Documents\Supplements\20624302.0.doc page 1
author: Brian Strongin
C:\Data\My Documents\Supplements\20624203.0.doc page 1
author: Brian Strongin
Geodon Consumer Information Therefore do not take Geodon if you have the following heart conditions:- long QT syndrome (a specific heart rhythm problem)- a recent heart attack- severe heart failure- certain irregularities of heart rhythm (discuss the specifics with your doctor)- Do not take Geodon if you are currently taking medications that should not be taken while you are taking Geodon, such as:- dofetilide ...
Curbing med errors involving Anzemet, Bentyl Problem: Potential medication errors have been reported involving the total drug content contained in each Anzemet (dolasetron mesylate injection, Aventis) ampule
author: Office of Drug Safety
subject: Reprinted with the permission of Drug Topics, Medical Economics Co., April 1, 2002
duplicates:http://www.fda.gov/cder/drug/MedErrors/anzemet.pdf
http://www.cancercare.on.ca/formulary/pdfmedicationinfo/Dolasetron.pdf For more information on this medication, please call your doctor or nurse, or the Cancer Centre Drug Information pharmacist. MEDICATION INFO SHEET DOLASETRON (doe- LASS- eh- tron) Other Names for this Medication: Anzemet (Brand Name) Appearance: Oral Tablets: Pale pink tablets in 50mg & 100 mg ...
http://www.cancercare.on.ca/formulary/pdfmedicationinfo/Dolasetron.pdf page 1 For more information on this medication, please call your doctor or nurse, or the Cancer Centre Drug Information pharmacist. MEDICATION INFO SHEET DOLASETRON (doe- LASS- eh- tron) Other Names for this Medication: Anzemet (Brand Name) Appearance: Oral Tablets: Pale pink tablets in 50mg & 100 mg ...
1997 New Drug Application (NDA) 20-489/S003 5/2/1997 9/18/1997 Anzemet Tablets/Dolasetron mesylate Approval Letter [791 KB] Medical Review(s) Part 1 [4.1 MB],+ Part 2 [3.4 MB] Part 3 [4 MB] Part 4 [5.2 MB] Part 5 [4.2 MB] Part 6 [3.3 MB] Part 7 [4.6 MB] Part 8 [4.1 MB] Part 9 [3.2 MB] Part 10 [4.5 MB] Part 11 [4.4 MB] Chemistry Review(s) & EA(Fonsi) [4.9 MB] Pharmacology Review(s) Part 1 [5.3 MB], Part 2 [5.3...
