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...
Prescription and Over-the-Counter Drug Product List: 4/2003 45 -D- XCEL PHARMS 1MG/ML N05929 001 APR CFTG -A- AP + 1MG/ML N05929 001 APR CFTG -A- DIHYDROEROGTAMINE MESYLATE -A- AP PADDOCK 1MG/ML N40475 001 APR 28, 2003 APR NEWA DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE; ORAL -A- TAZTIA XT -A- AB4 ANDRX PHARMS 120MG N75401 001 APR 10, 2003 APR NEWA -A- AB4 180MG N75401 002 APR 10, 2003 APR NEWA -A- AB4 240MG N75401 003 APR 10,...
author: AUTHOR
Prescription and OTC Drug Product List 10/1998 Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 10: October 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE BENZYL PENICILLOYL-POLYLYSINE CAPSULE; ORAL INJECTABLE; INJECTION BUTALBITAL, ACETAMINOPHEN AND CAFFEINE PRE-PEN - ADD - AB WEST WARD 500MG;50MG;40MG N40261...
FDA Drug Approvals List July 2000 - Drug Approvals for July 2000 Definitions and Notes Original New Drug Applications Original Application #: 050779 Approval Date: 27-JUL-00 Trade Name: CEFAZOLIN AND DEXTROSE Chemical Type: 5 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: B BRAUN MEDICAL INC Active Ingredient(s): CEFAZOLIN SODIUM OTC/RX Status: RX Indication(s): For the treatment of respiratory tract...
Geltex Report Template Sevelamer hydrochloride is poly( allylamine hydrochloride) crosslinked with epichlorohydrin in which forty percent of the amines are protonatedSevelamer hydrochloride is hydrophilic, but insoluble in waterSevelamer Hydrochloride NH 2 °nHCl NH° nHCl OH NH 2 °nHCl NH° nHCl c a...
author: Debra Sojka
Geltex Report Template page 1
author: Debra Sojka
FDA Drug Approvals List- October 1998 Drug Approvals for October 1998 Definitions and Notes October 1998 Original New Drug Applications Original Application #: 020926 Approval Date: 30-OCT-98 Trade Name: RENAGEL Chemical Type: 1 Therapeutic Potential: S Dosage Form: CAPSULE Applicant: GELTEX PHARMACEUTICALS INC Active Ingredient(s): SEVELAMER HYDROCHLORIDE OTC/RX Status: RX Indication(s): For the...
Nabi Biopharmaceuticals - Product Publications PRODUCTS Products Overview PhosLo® Nabi-HB® WinRho SDF® Aloprim™ Plasma Products -----Antibody Plasma -----Products -----Plasma Centers Product Publications Material Safety Data Sheets - Product Publications If you wish to receive a copy of any of the following publications, please contact Nabi Biopharmaceuticals Medical...
PDF cover 0509.qxd This weeks UK PDJ reported the entry into force of the SPC for Chiron's humanised monoclonal antibody treatment for breast cancer, trastuzumab, "as present in the EMEA approved product Herceptin ®", which is based on EP153114.Renagel) is indicated for the control of serum phosphate levels in...
author: LEmson
PDF cover 0509.qxd page 1
author: LEmson
Approved Products_2004.xls Number A pproval Date Trade Name Generic/ Chemical name Indication Company 1 Oct- 82 Humulin Human Insulin Type I Diabetes Lilly / Genentech 2 Oct- 85 Protro pin Human Growth Hormone Hypoptuitary dwarfism Genentech 3 Jun- 86 Intron A Interferon Al pha 2B Hairy Cell Leukemia Schering Plough / Biogen 4 Jun- 86 OKT- 3 Anti CD3 Mab Acute Trans plant Rejection JNJ / OrthoBiotech 5 Jun- 86...
author: Reijer
Approved Products_2004.xls page 3
author: Reijer
http://www.anormed.com/documents/foz_renagel.pdf Presented at the ISN/ ASN World Congress of Nephrology October 2001, San Francisco ][ A3863] Effects of the Phosphate Binder Renagel ® (Sevelamer) on Biochemical Parameters and Bone Histology in a Chronic Renal Failure (CRF) Rat Model
Geltex Report Template page 6
author: Debra Sojka
20926LBL.PDF Page 1 2.1 PACKAGE INSERT (LOGO) Renagel ® Capsules (sevelamer hydrochloride) 403 mg Renagel ® Capsules (sevelamer hydrochloride) [se vel¢ ¢ a mer] DESCRIPTION Renagel * Capsules contain sevelamer hydrochloride, a polymeric phosphate binder intended for oral administrationSevelamer hydrochloride is poly( allylamine hydrochloride)...
author: Unknown
20926LBL.PDF page 4
author: Unknown
20926LBL.PDF page 1
author: Unknown
Information Meeting on New Product Information Meeting on New Product Presentations- The Positioning of Capecitabine for Breast Cancer Masanori Nishida Medical Business & Science DeptSevelamer Hydrochloride Fumio Ishihata Medical Business & Science Dept
EFFICACY SUPPLEMENTS APPROVED IN CY 2000 Also, under GRANULES FOR ORAL SUSPENSION in the DOSAGE AND ADMINISTRATION section, the age range for children in the dosing tables was expanded to -age 5 months through 12 years.- SOTALOL HYDROCHLORIDE BERLEX LABS 21-151 22-Jun-98 22-Feb-00 N 000 N 20.1 Provides for the new indication of prolongation of time to recurrence of symptomatic AFIB/AFL in patients with symptomatic...
What's new at CDER by Date New and Generic Drug Approvals Benazepril Hydrochloride Tablets, Mylan Pharmaceuticals Benazepril Hydrochloride Tablets, Ranbaxy Benazepril Hydrochloride Tablets, Andrx Pharmaceuticals Benazepril Hydrochloride Tablets, Genpharm Benazepril Hydrochloride Tablets, Ivax Pharmaceuticals Benazepril Hydrochloride Tablets, Teva Pharmaceuticals Benazepril ...
author: Paul Stauffer
