http://www.fda.gov/cder/orange/appendix_a.txt 4, ACETAMINOPHEN PHENAPHEN-650 W/ CODEINE, ACETAMINOPHEN PHENAZINE, PHENDIMETRAZINE TARTRATE PHENAZINE-35, PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE PHENERGAN FORTIS, PROMETHAZINE HYDROCHLORIDE PHENERGAN PLAIN, PROMETHAZINE HYDROCHLORIDE PHENERGAN VC W/ CODEINE, CODEINE PHOSPHATE PHENERGAN VC, PHENYLEPHRINE HYDROCHLORIDE PHENERGAN W/ CODEINE, CODEINE...
20984_Raplon.htm Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Raplon (Rapacuronium Bromide) Injection Company:- Organon, Inc
author: Paul Stauffer
NMEs Approved in CY 1999 NMEs Approved in Calendar Year 1999 NDA Number Generic Name- Trade Name Dosage Form Applicant - --- Classification- Approval Date - - - - - - - 20-863 Cilostazol Pletal Tablet Otsuka Pharm 1S 01-15-1999 20-886 Alitretinoin Panretin Topical Gel Ligand Pharm 1-PV 02-02-1999 20-955 Sodium Ferric Gluconate Complex Ferrlicit Injectable R&D Labs 1P 02-18-1999 21-007 Amprenavir Agenerase...
author: Elaine Abraham
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 8/1999 RTU IN PLASTIC CONTAINER - DLT - MAR 19, 1999 - ADD - AP + BAXTER HLTHCARE 500MG/100ML N18657 001 - DLT - AP + SCS 500MG/100ML N18657 001 LORACARBEF MINOCYCLINE HYDROCHLORIDE CAPSULE; ORAL LORABID CAPSULE; ORAL - ADD - KING PHARMS 200MG N50668 001 - DLT - MINOCYCLINE HCL - ADD - DEC 31, 1991 - DLT - AB WARNER CHILCOTT EQ 50MG BASE N63066 001 - ADD - + 400MG N50668 002 - DLT - AUG 14,...
FDA Drug Approvals List August 1999 Drug Approvals for August 1999 Definitions and Notes Original New Drug Applications Original Application #: 020984 Approval Date: 18-AUG-99 Trade Name: RAPLON Chemical Type: 1 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: ORGANON INC SUB AKZO NOBEL INC Active Ingredient(s): RAPACURONIUM BROMIDE OTC/RX Status: RX Indication(s): For outpatients and...
Report to the Nation: Drug Review Rapacuronium bromide (Raplon) is an adjunct to general anesthesia to facilitate tracheal intubation and provide skeletal muscle relaxation
author: OLIVERN
CDER Report to the Nation: 2001 Rapacuronium (Raplon), an injectable anesthesia drug, was voluntarily withdrawn from the market after its manufacturer received reports indicating that the drug might have been associated with bronchospasm, a mild to severe inability to breathe normally that can lead to permanent injury or death
author: OLIVERN
News Along the Pike, March 2001 Temple in Florida Rawls-Palmer Award Photo CDER's Support Staff Workshop Scheduled for April 27 Ombudsman's Corner: Minutes Save Months Parklawn Classic 5-Mile Run, 2.5-Mile Walk Set for April 27 Information Technology Corner: PCs at Work, Home Upgraded; National Drug Code Directory April IT Training Web InSights: CDER Internet Site Grows to 30,000 Pages, 600,000 Users a Month...
author: Oliver
00-173 PhRMA MedChild2000 Re5/3 2000 Children N E W M E D I C I N E S I N D E V E L O P M E N T F O R Survey P R E S E N T E D B Y A M E R I C A' S P H A R M A C E U T I C A L C O M P A N I E S A new survey by the Pharmaceutical Research and Manufacturers of America (PhRMA) found 217 medicines and vaccines in development to help and heal children
author: RL
00-173 PhRMA MedChild2000 Re5/3 page 13
author: RL
News Along the Pike March 2001 News Along the Pike, April 5, 2001 1 CDER's Support Staff Workshop Scheduled for April 27 Comment Period Extended for Rx Labeling Proposal April 26 'CDER Live' Talk Show to Feature Proposed Rule VOLUME 7, ISSUE 3 CENTER FOR DRUG EVALUATION AND RESEARCH MARCH 2001 Clinical Pharmacologists Honor DrRapacuronium Withdrawn; 2 Eye...
author: Food and Drug Administration
subject: Center for Drug Evaluation and Research
News Along the Pike March 2001 page 6
author: Food and Drug Administration
subject: Center for Drug Evaluation and Research
CDER 1999 Report to the Nation 1999 new molecular entities: Alitretinoin (Panretin) Aminolevulinic acid hydrochloride (Levulan Kerastick) Amprenavir (Agenerase) Bexarotene (Targretin) Cilostazol (Pletal) Dalfopristin/ quinupristin (Synercid) Dexmedetomidine hydrochloride (Precedex) Dofetilide (Tikosyn) Doxercalciferol (Hectorol) Entacapone (Comtan) Epirubicin hydrochloride (Ellence) Exemestane (Aromasin)...
author: Center for Drug Evaluation and Research
subject: Improving Public Health Through Human Drugs
CDER 1999 Report to the Nation page 13
author: Center for Drug Evaluation and Research
subject: Improving Public Health Through Human Drugs
CDER 1999 Report to the Nation page 11
author: Center for Drug Evaluation and Research
subject: Improving Public Health Through Human Drugs
Contents Vol. 41, No. 13, 2002 1005- 1019 D Smith, E Schmid, B Jones Review Articles Clinical Pharmacokinetics of Tegaserod, a Serotonin 5- HT4 Receptor Partial Agonist with Promotile Activity Drug Disposition 1021- 1042 S Appel- Dingemanse Clinical Pharmacokinetics and Pharmacodynamics of Insulin Lispro Mixtures Drug Disposition 1043- 1057 P Roach, JR Woodworth Pharmacokinetics and Pharmacodynamics of ...
author: Adis International Limited
subject: Clinical Pharmacokinetics
