http://www.fda.gov/cder/orange/appendix_a.txt 400, ERYTHROMYCIN ETHYLSUCCINATE E.E.S., ERYTHROMYCIN ETHYLSUCCINATE EC-NAPROSYN, NAPROXEN ECONAZOLE NITRATE, ECONAZOLE NITRATE ECONOCHLOR, CHLORAMPHENICOL ECONOPRED PLUS, PREDNISOLONE ACETATE ECONOPRED, PREDNISOLONE ACETATE EDECRIN, ETHACRYNATE SODIUM EDECRIN, ETHACRYNIC ACID EDETATE DISODIUM, EDETATE DISODIUM EDEX, ALPROSTADIL EDROPHONIUM CHLORIDE PRESERVATIVE FREE, EDROPHONIUM...
Pentosan Polysulfate Pentosan Polysulfate 4).beta.-D-xylan; 2,3-bis(hydrogen sulfate), sodium saltPentosan polysulfate; Xylan polysulfate; Pentosan polysulfate Sodium; Pentosan sulfate; SP54; SP-54; Elmiron; PZ68."> Pentosan polysulfate is one of several sulfated polysaccharides that inhibits T-cell tropic strains of HIV-1
Prescription and OTC Drug Product List 6/2002 -A- + GD SEARLE LLC EQ 500MG BASE/VIAL N18353 001 JUL CAHN -D- + SCS EQ 500MG BASE/VIAL N18353 001 JUL CAHN MIDAZOLAM HYDROCHLORIDE INJECTABLE; INJECTION MIDAZOLAM HCL -A- AP ABBOTT EQ 1MG BASE/ML N75857 001 JUL 22, 2002 JUL NEWA -A- AP EQ 5MG BASE/ML N75857 002 JUL 22, 2002 JUL NEWA MIDODRINE HYDROCHLORIDE TABLET; ORAL PROAMATINE -A- + SHIRE LABS 5MG N19815 002 SEP 06, 1996 JUL CRLD...
DDPA March 1996 20-193 ELMIRON BAKER NORTON PENTOSAN POLYSULFATE SODIUM 01-MAR-96 (CAPSULE) MIAMI, FL 100MG 33178 (ANTICOAGULANT) 20-486 VANCERIL DS SCHERING BECLOMETHASONE DIPROPIONATE 06-MAR-96 (AEROSOL, METERED) KENILWORTH, NJ 0.084MG/INH 07033 (CORTICOSTEROID) 20-397 ZANAFLEX ATHENA NEUROSCIENCES TIZANIDIN E HYDROCHLORIDE 11-MAR-96 (TABLET) S SAN FRANCISCO, CA EQ 4MG BASE 94080...
Drug Approvals September 1996 Drug Approvals for September 1996 Definitions and Notes Original New Drug Applications Original Application #: 020592 Approval Date: 30-SEP-96 Trade Name: ZYPREXA Chemical Type: 1 Therapeutic Potential: S Dosage Form: TABLET Applicant: ELI LILLY AND CO Active Ingredient(s): OLANZAPINE OTC/RX Status: RX Indication(s): MANAGEMENT OF THE MANIFESTATIONS OF PSYCHOTIC DISORDERS Original...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt 4Q2003 TYPE2ACTIVETEXT DMF # SUBMIT DATE HOLDER SUBJECT 131 01-Jan-40 CENTRAL SOYA SOYBEAN STEROL PRODUCTS 183 29-Feb-52 INTERNATIONAL SPECIALTY PRODUCTS POLYVINYL PYRROLIDONE-IODINE 10 191 24-Jan-56 MALLINCKRODT CHEMICAL INC PARZONE BITARTRATE (DIHYDROCODEINE BITARTRATE) 240 11-Jan-57 PHARMACIA & UPJOHN 19-NOR-ETHINYLTESTOSTERONE 281 21-Nov-57 UNIMED PHARMACEUTICALS INC 2 HYDROXY...
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls Arthur Shaw CDER User $ ($) $ ($) $ ($) $ ($) $ $ () $ - () - $ $ () $ - () - -- -- $ ($) $ ($) $ ($) $ ($) / / // -- - - : : :: : () () () () () - $ $ () $ - () - $ $ () $ - : :: : 4Q2003 TYPE2ACTIVEEXCEL DMF # SUBMIT DATE HOLDER SUBJECT CENTRAL SOYA SOYBEAN STEROL PRODUCTS INTERNATIONAL SPECIALTY PRODUCTS POLYVINYL PYRROLIDONE-IODINE 10 MALLINCKRODT CHEMICAL INC PARZONE BITARTRATE ...
Generic Names of Some Trade Name Drugs, THE MERCK MANUAL OF HEALTH & AGING Committed to Providing Medical Information Table of Contents Index Enlarge Text Reset Text Shrink Text -- Buy the Book Learn about participating in clinical trials at this government website: www.clinicaltrials.gov - APPENDIX I - Drug Names: Generic and Trade TOPICS - Introduction -~ Some Trade Names of Generic Drugs -~ Generic Names of Some Trade Name Drugs - Generic Names of Some...
Some Trade Names of Generic Drugs, THE MERCK MANUAL OF HEALTH & AGING Committed to Providing Medical Information Table of Contents Index Enlarge Text Reset Text Shrink Text -- Buy the Book Learn about participating in clinical trials at this government website: www.clinicaltrials.gov - APPENDIX I - Drug Names: Generic and Trade TOPICS - Introduction -~ Some Trade Names of Generic Drugs-~ Generic Names of Some Trade Name Drugs - Some Trade Names of...
Bladder Infection (Cystitis): Urinary Tract Infections: 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...
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 OfficeElmiron (...
Ortho-McNeil: Our Products - - -- PRODUCT THERAPY DESCRIPTION - DITROPAN ® (oxybutynin chloride) Urology Multi-dose antispasmodic anticholinergic agent to relax bladder smooth muscle DITROPAN XL ® Extended- release Tablet (oxybutynin chloride) Urology Antispasmodic, anticholinergic agent to relax bladder smooth muscle; available in 5mg, 10mg and 15mg tablets ELMIRON ® Capsules (pentosan ...
Ortho-McNeil: Bladder Health - - Ortho-McNeil Pharmaceutical offers a range of solutions for some of the most common urological health conditions facing men and women today, including overactive bladder, interstitial cystitis, and urinary tract infections
Ortho-McNeil: Our Products Also available as 15mg and 25mg sprinkle capsules for oral administration as whole capsules or opened and sprinkled onto soft food AXERT ® Tablets (almotriptan malate) Migraine Oral medication for acute treatment of migraine with or without aura in adults; available in 6.25mg and 12.5mg, 6-tablet blister - PARAFON FORTE ® DSC Caplets (chlorzoxazone) Pain Management Centrally...
Ortho-McNeil: Our Products Prescribing Information - ALL-FLEX ® Arcing Spring Diaphragm Contraceptive Molded, dry natural rubber vaginal diaphragm containing a distortion-free, dual spring-within-a-spring AXERT ® Tablets (almotriptan malate) Migraine Oral medication for acute treatment of migraine with or without aura in adults; available in 6.25mg and 12.5mg, 6-tablet blister - DITROPAN ® ...
Drug Index Penicillin, 2Isoquin-OHPrNH2 analog Penicillin, 2Isoquin-OHPrNH2 analog Pentafuside target="frame2" ; DP-178; T-20; GP41 127-162 AA; Enfuvirtide; Fuzeon Pentosan Sulfate ; Elmiron; SP54; Xylan Sulfate; PETT ; N-(2-Phenethyl)-N'-(2-thiazolyl)thiourea; LY-73497 PETT Cl, F deriv
Drug Index Penicillin, 2Isoquin-OHPrNH2 analog Penicillin, 2Isoquin-OHPrNH2 analog Pentafuside target="frame2" ; DP-178; T-20; GP41 127-162 AA; Enfuvirtide; Fuzeon; Pentosan Sulfate ; Elmiron; SP54; Xylan Sulfate; PETT ; N-(2-Phenethyl)-N'-(2-thiazolyl)thiourea; LY-73497 PETT Cl, F deriv
Elmiron PI ELMIRON ® mg (pentosan polysulfate sodium) Capsules Prescribing Information DESCRIPTION Pentosan polysulfate sodium is a semi- synthetically produced heparin- like macromolecular carbohydrate derivative which chemically and structurally resembles glycosaminoglycans
author: Donna
Elmiron PI page 3
author: Donna
Elmiron PI page 2
author: Donna
Elmiron PI page 1
author: Donna
http://www.fda.gov/cder/reports/cderfact.pdf page 24
author: Carolyn Spencer
http://www.fda.gov/cder/reports/cderfact.pdf Center for Drug Evaluation and Research fact book 1997 Note: This publication is no longer current
author: Carolyn Spencer
