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...
NMEs Approved in CY 2002 NMEs Approved in Calendar Year 2002 - NDA Number Generic Name Trade Name Dosage Form Applicant *Classification Approval Date 21-232 Nitisinone Orfadin Capsule Swedish Orphan -- 1PV 01-18-2002 21-286 Olmesartan Medoxomil Benicar Tablet Sankyo- 1S 04-25-2002 21-344 Fulvestrant Faslodex Injection AstraZeneca 1S 04-25-2002 21-272 Treprostinil Sodium Remodulin Injection United...
author: Susan Daugherty
Prescription and Over-the-Counter Drug Product List: 3/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL FIORICET W/ CODEINE -D- AB + NOVARTIS 325MG;50MG;40MG;30MG N20232 001 JUL 30, 1992 MAR CAHN -A- AB + WATSON PHARMS 325MG;50MG;40MG;30MG N20232 001 JUL 30, 1992 MAR CAHN ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL CODRIX -A- + ANDRX PHARMS 500MG;30MG N40441 001...
author: AUTHOR
Prescription and OTC Drug Product List 12/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACARBOSE TABLET; ORAL PRECOSE -D- BAYER 25MG N20482 004 MAY 29, 1997 DEC CAHN -D- 50MG N20482 001 SEP 06, 1995 DEC CAHN -D- + 100MG N20482 002 SEP 06, 1995 DEC CAHN -A- BAYER PHARMS 25MG N20482 004 MAY 29, 1997 DEC CAHN -A- 50MG N20482 001 SEP 06, 1995 DEC CAHN -A- + 100MG N20482 002 SEP 06, 1995 DEC CAHN ACYCLOVIR -A- CREAM;...
FDA Drug Approvals List October 1999 Application #: 020156 Efficacy Supplement#: 022 Type: SE2 to Original New Drug Application Approval Date: 28-OCT-99 Trade Name: VIDEX Dosage Form: POWDER, FOR RECONSTITUTION Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE Active Ingredient(s): DIDANOSINE OTC/RX Status: RX Efficacy Claim:Provides for a new strength as well as allowing a change in dosing interval...
Triptans (serotonin receptor agonists) for migraine headaches - [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 - References Triptans (serotonin receptor agonists) for migraine headaches - [Medication] - Quest Diagnostics Patient Health Library Triptans (serotonin receptor agonists) for migraine headaches - [Medication] - Quest Diagnostics Patient Health Library Brain and nerves,...
Neurogen Corporation - - - - - - - Thomas A.
BioPortfolio Limited Many companies could benefit from assessing their existing delivery technologies in other therapeutic areas, such as diabetes (needle-free injections, inhaled insulins), HRT (sustained-release patch technology) and others 10 CHAPTER 2 INTRODUCTION AND SCOPE 21 Disease overview 21 Etiology 21 Diagnosis and classification of migraine 22 Migraine diagnosis 22 Patient history and diaries...
Database R R - investigational drugs, therapies and- vaccines # - 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 From this page you may order documents with information covering investigational products To purchase documents on-line click on -link attached to selected document!- The fee is $15 per document Documents are delivered by e-mail...
Database E E - investigational drugs, therapies and vaccines # - 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 From this page you may order documents with information covering investigational products To purchase documents on-line click on- link attached to selected document!- The fee is $15 per document Documents are delivered by e-mail...
Drug Approval Package FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Relpax (Eletriptan) Tablets Company:- Pfizer Inc
CDER 2002 Report to the Nation; Drug Review Food and Drug Administration • Center for Drug Evaluation and Research About CDER - Report Search CDER Report to the Nation: 2002 Table of Contents Adobe Acrobat version of this document 1 Drug Review Index Mission Highlights New Drug Review List of priority new drugs List of new molecular entities List of orphan new drugs New Drug Review Statistics Priority new drug statistics...
author: OLIVERN
FY 2003 NDA Approvals for New Molecular Entities FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -FY 2003 NDA Approvals for New Molecular Entities as of September 30, 2003 NDA # Trade Name (Generic Name) Dosage Form Applicant Date of- Approval Class Indication(s) 21-445 Zetia------ (ezetimibe)-- Tablets MSP Singapore -25-Oct-02 1S Zetia is indicated for (1) Primary hypercholesterolemia ...
Zomig NS AP Ltr Sep 30.doc Rev 09/ 03 SIC Rx only ZOMIG (zolmitriptan) Nasal Spray For Nasal Use Only DESCRIPTION ZOMIG ® (zolmitriptan) Nasal Spray contains zolmitriptan, which is a selective 5- hydroxytryptamine 1B/ 1D (5- HT 1B/ 1D ) receptor agonist
author: CHENLA
Zomig NS AP Ltr Sep 30.doc page 25
author: CHENLA
Eletriptan 1 RELPAX (eletriptan hydrobromide) Tablets DESCRIPTION RELPAX ® (eletriptan) Tablets contain eletriptan hydrobromide, which is a selective 5- hydroxytryptamine 1B/ 1D (5- HT1B/ 1D) receptor agonistRELPAX Tablet for oral administration contains 24.2 or 48.5 mg of eletriptan hydrobromide equivalent to 20 mg or 40 mg of ...
author: CN=Pearl Rawson/O=Pharmaceuticals
Eletriptan page 20
author: CN=Pearl Rawson/O=Pharmaceuticals
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author: CN=Pearl Rawson/O=Pharmaceuticals
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author: CN=Pearl Rawson/O=Pharmaceuticals
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author: CN=Pearl Rawson/O=Pharmaceuticals
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author: CN=Pearl Rawson/O=Pharmaceuticals
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author: CN=Pearl Rawson/O=Pharmaceuticals
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author: CN=Pearl Rawson/O=Pharmaceuticals
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author: CN=Pearl Rawson/O=Pharmaceuticals
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author: CN=Pearl Rawson/O=Pharmaceuticals
