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BioPortfolio Limited
The Gastrointestinal Market 2003: New Blockbusters and Competitive Dynamics 1 Gastrointestinal Conditions 1.1 An Introduction to Gastrointestinal Conditions 1.2 Report Objectives 1.3 Worldwide Impact of Gastrointestinal Conditions 1.3.1 Demographic Prevalence Graph 1.1 Percentage of Hospitalizations Due to Gastrointestinal Causes Graph 1.2 Percentage of Diagnostic and Therapeutic...
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Drug Approvals - A
ANDA 40-419 5/31/01 6/5/01 - - Aciphex (Rabeprazole Sodium) Delayed-Release Tablets, Rx Eisai Inc
NDA 20-973/S16 8/1/03 8/15/03 - Aciphex (Rabeprazole Sodium) Delayed-Release Tablets, Rx Eisai Inc
NDA 20-973/S15 9/30/02 10/2/02 Aciphex (Rabeprazole Sodium) Delayed-Release Tablets, Rx Eisai Inc
- NDA 21-456- NDA 20-973/S-013 11/8/02 11/18...
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Paragraph IV Patent Certifications
- DRUG NAME DOSAGE FORM STRENGTH RLD Acetaminophen Extended-release Tablets 650 mg Tylenol Acetaminophen/ Aspirin/ Caffeine Tablets 250 mg/250 mg/ 65 mg Excedrin (migraine) Acetaminophen and Tramadol Hydrochloride Tablets 325 mg/ 37.5 mg Ultracet Acyclovir Sodium1 Injection 50 mg/mL, 10 mL and 20 mL vials Zovirax Albuterol Sulfate Oral Syrup 2 mg(base)/ 5 mL Ventolin Albuterol...
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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,...
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Aciphex (Rabeprazole Sodium) Tablets
Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Aciphex ( Rabeprazole Sodium) Tablets Company:- Eisai Medical Research Application No.:- 020973/S-13, 021456 Approval Date:-11/8/2002 Approval Letter(s) - Printed Labeling - Part 1 - Part 2 - Medical Review(s) - Part 1 - Part 2 - Chemistry Review(s) - Pharmacology Review(s)...
author: USERNAME
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Report to the Nation: Drug Review
Rabeprazole sodium (Aciphex) is a once-a-day proton pump inhibitor to heal duodenal ulcers and erosive gastroesophageal reflux disease
Priority new drug approvals: Alitretinoin Amprenavir (2 dosage forms) Aspirin/extended release-dipyridamole Bexarotene Busulfan Caffeine citrate Cytarabine liposome Dalfopristin/quinupristin Epirubicin hydrochloride Ganirelix acetate...
author: OLIVERN
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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
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FDA Drug Approvals List August 2001
JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE Active Ingredient(s): COPPER OTC/RX Status: RX Application #:018612 Labeling Supplement#: 026 To Original New Drug Application Approval Date: 24-AUG-01 Trade Name: NICORETTE Dosage Form: GUM, CHEWING Applicant: SMITHKLINE BEECHAM CONSUMER HEALTHCARE LP Active Ingredient(s): NICOTINE POLACRILEX OTC/RX Status: RX Application #: 014879 Labeling...
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20973_Aciphex.htm Aciphex Delayed Release (Rabeprazole Sodium) Tablets
Food and Drug Administration • Center for Drug Evaluation and Research Approval Package [http://internet-dev/cder/templates/2ndrow-component.htm] [http://internet-dev/cder/templates/sidebar-component.htm] Aciphex Delayed Release (Rabeprazole Sodium) Tablets Company:- Eisai Inc
Application No.:- 020973 Approval Date:-8/19/99 - Approval Letter(s) (944 KB) Medical...
author: Paul Stauffer
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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...
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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...
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Prescription and OTC Drug Product List 5/2002
2 -D- + ROBINS AH 325MG;15MG N84444 001 MAY DISC -A- @ 325MG;15MG N84444 001 MAY DISC SOLUTION; ORAL ACETAMINOPHEN AND CODEINE PHOSPHATE -D- AA ALPHARMA 120MG/5ML;12MG/5ML N85861 001 MAY CRLD -A- AA + 120MG/5ML;12MG/5ML N85861 001 MAY CRLD TYLENOL W/ CODEINE -D- AA + JOHNSON RW 120MG/5ML;12MG/5ML N85057 001 MAY DISC -A- @ 120MG/5ML;12MG/5ML N85057 001 MAY DISC TABLET; ORAL...
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Efficacy Supplements Approved in Calendar Year 2002 (SE1-SE7 AND SE8s
RABEPRAZOLE SODIUM EISAI (US) 20-973 SE1 009 12-Apr-01 12-Feb-02 - 10.1 Provides for the use of Aciphex (rabeprazole sodium) Delayed-Release Tablets for the treatment of symptomatic gastroesophageal reflux disease (GERD)
RABEPRAZOLE SODIUM EISAI MEDCL RES 21-456 N 000 10-Jan-02 8-Nov-02 - 9.9 Provides for the use of ACIPHEX (rabeprazole sodium) Delayed...
author: Darlene Norris
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20-973 S-009 ACIPHEX.pdf
Rabeprazole sodium is known chemically as 2-[[[ 4-( 3- methoxypropoxy)- 3- methyl- 2- pyridinyl] methyl] sulfinyl]- 1H– benzimidazole sodium salt
The structural formula is: RABEPRAZOLE SODIUM ACIPHEX® is available for oral administration as delayed- release, enteric- coated tablets containing 20 mg of rabeprazole sodium
Metabolism: Rabeprazole...
author: gracej
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20-973 S-009 ACIPHEX.pdf page 12
author: gracej
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20-973 S-009 ACIPHEX.pdf page 11
author: gracej
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20-973 S-009 ACIPHEX.pdf page 10
author: gracej
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20-973 S-009 ACIPHEX.pdf page 9
author: gracej
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20-973 S-009 ACIPHEX.pdf page 2
author: gracej
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20-973 S-009 ACIPHEX.pdf page 1
author: gracej
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C:\My Documents\N20973.S009.approval.letter.February-2001.DOC.DOC
The structural formula is: RABEPRAZOLE SODIUM ACIPHEX® is available for oral administration as delayed- release, enteric- coated tablets containing 20 mg of rabeprazole sodium
Metabolism: Rabeprazole is extensively metabolized
PHARMACODYNAMICS Mechanism of Action Rabeprazole belongs to a class of antisecretory compounds (substituted benzimidazole...
author: Maria Walsh
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C:\My Documents\N20973.S009.approval.letter.February-2001.DOC.DOC page 12
author: Maria Walsh
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C:\My Documents\N20973.S009.approval.letter.February-2001.DOC.DOC page 11
author: Maria Walsh
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C:\My Documents\N20973.S009.approval.letter.February-2001.DOC.DOC page 10
author: Maria Walsh
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C:\My Documents\N20973.S009.approval.letter.February-2001.DOC.DOC page 9
author: Maria Walsh
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