Workshops - - - - Collapse All - Home - xMAP Technology - Support - Our Company - Contact Home ->- Planet xMAP ->- Workshops - - - - Planet xMAP 2005 Symposium -- Discover a World of Applications with-xMAP A® Technology - - - - - - Planet xMAP 2005 Symposium Proceedings - 2nd Annual Planet xMAP Symposium April 25-27, 2005 Omni Austin Hotel Downtown Austin, Texas - Poster Display ---------...
author: Robert Cordes
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KHO0401 pr241 revA1 apr204 (c-Kit [pS823]).pub 1 Immunoassay Kit Catalog #KHO0401 Human* c- Kit [pY823] BioSource International, Inc.
author: louises
duplicates:http://www.biosource.com/content/emailNewsletterContent/issue28/KHO0401.PDF
KHO0401 pr241 revA1 apr204 (c-Kit [pS823]).pub page 5
author: louises
duplicates:http://www.biosource.com/content/emailNewsletterContent/issue28/KHO0401.PDF
KHO0391 pr240 revA1 apr204 (c-Kit [Total]).pub 1 Immunoassay Kit Catalog #KHO0391 Human c- Kit (Total) BioSource International, Inc.
author: louises
duplicates:http://www.biosource.com/content/emailNewsletterContent/issue28/KHO0391.PDF
KHO0391 pr240 revA1 apr204 (c-Kit [Total]).pub page 5
author: louises
duplicates:http://www.biosource.com/content/emailNewsletterContent/issue28/KHO0391.PDF
http://www.fda.gov/cder/orange/appendix_a.txt RTU IN PLASTIC CONTAINER, METRONIDAZOLE FLAGYL I.V., METRONIDAZOLE HYDROCHLORIDE FLAGYL, METRONIDAZOLE FLAREX, FLUOROMETHOLONE ACETATE FLAVORED COLESTID, COLESTIPOL HYDROCHLORIDE FLAVOXATE HCL, FLAVOXATE HYDROCHLORIDE FLAXEDIL, GALLAMINE TRIETHIODIDE FLECAINIDE ACETATE, FLECAINIDE ACETATE FLEXERIL, CYCLOBENZAPRINE HYDROCHLORIDE FLEXICORT, HYDROCORTISONE FLOLAN, EPOPROSTENOL SODIUM...
NDA Supplements Approved under Subpart H NDA Supplements Approved under Subpart H NDA # Supp # Trade Name Generic- Name Clock Date Approval Date AP Time Approval Basis Indication 50697 N Biaxin Clarithromycin- 2-Nov-92 23-Dec-93 13.7 S Treatment of disseminated mycobacterial infections due to Mycobacterium avium and Mycobacterium intracellular 20221 SE1 002 Ethyol Amifostine 9-Feb-96 15-Mar-96 1.2 S Provides for...
EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2003 IMATINIB MESYLATE NOVARTIS < td WIDTH="75"> 21-335 SE5 003 28-Jun-02 20-May-03 Y 10.7 Provides for the use of Gleevec (imatinib mesylate) Tablets for the treatment of pediatric patients with Ph+ chronic phase CML whose disease has recurred after stem cell transplant or who are resistant to interferon alpha therapy
NDA Approvals for Calendar Year 2003 NDA APPROVALS FOR CALENDAR YEAR 2003 Updated through December 31, 2003 NDA NUMBER DRUG NAME GENERIC NAME APPLICANT/ SPONSOR CHEMICAL TYPE THERAPEUTIC CLASS APPROVAL DATE - 21434 Xanax XR Alprazolam Pharmacia and Upjohn FR 3 S 17-Jan-03 21305 Sodium Iodide I-131 Sodium Iodide I-131 DraxImage 3,5 S 24-Jan-03 20414 Pyridostigmine Bromide Pyridostigmine Bromide US Army 3 P 05-Feb-03...
author: Susan Daugherty
Gleevec (Imatinib Mesylate) Information Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Gleevec (Imatinib Mesylate) - Gleevec is approved to treat a rare cancer called Chronic Myeloid Leukemia (CML), FDA grants Gleevec regular approval as a second line treatment for refractory Chronic Myeloid Leukemia
author: USERNAME
Drug Approval Package Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Gleevec (Imatinib Mesylate) Capsules Company:--Novartis Application No.:--21-335/S1 Approval Date:-2/1/2002 Approval Letter(s) - Printed Labeling - Medical Review(s)- Part 1 - Part 2 - Chemistry Review(s) - Clinical Pharmacology Biopharmaceutics Review(s)- Part 1 -...
author: USERNAME
Drug Approval Package Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Gleevec (Imatinib Mesylate) Capsules Company:--Novartis Pharmaceuticals Corporation Application No.:--21-335/S4 Approval Date:-12/20/2002 Approval Letter(s) - Printed Labeling - Medical Review(s)- Part 1 - Part 2 - Part 3 - Chemistry Review(s) - Pharmacology Review(s)...
author: USERNAME
21335_Gleevec.htm Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Gleevec (Imatinib Mesylate) Capsules Company:--Novartis Pharmaceuticals Corporation Application No.:--21-335 Approval Date:-5/10/2001 - Approval Letter(s) - Printed Labeling - Medical Review(s) Part 1 - Part 2 - Part 3 - Chemistry Review(s) - Pharmacology Review(s)...
author: Paul Stauffer
Prescription and Over-the-Counter Drug Product List: 6/2003 >D> AP + WYETH AYERST 5,000 UNITS/VIAL N17055 001 JUN DISC >A> @ 5,000 UNITS/VIAL N17055 001 JUN DISC >D> AP + 10,000 UNITS/VIAL N17055 002 JUN DISC >A> @ 10,000 UNITS/VIAL N17055 002 JUN DISC GUANABENZ ACETATE TABLET; ORAL GUANABENZ ACETATE >D> AB WATSON LABS EQ 8MG BASE N74025 002 FEB 28, 1994 JUN CRLD >A> AB + EQ 8MG BASE N74025 002 FEB 28, 1994 JUN CRLD >D> WYTENSIN >D> AB WYETH...
author: AUTHOR
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
Gleevec (Imatinib Mesylate) Questions and Answers Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Gleevec (Imatinib Mesylate) - Questions and Answers What is Gleevec Gleevec used forGleevec workGleevec is that it can be given by mouth instead of by injectionGleevec be taken
author: USERNAME
NDAs Approved under Subpart H NDAs Approved under Subpart H NDA # Trade Name Generic -Name Clock Date Approval Date AP Time Approval Basis Indication - - - - - - - - 20199 Hivid Zalcitabine 31-Oct-91 19-Jun-92 7.6 S Combination therapy with zidovudine in advanced HIV infection - - - - - - - - 50698 Biaxin Clarithromycin- 2-Nov-92 23-Dec-93 13.7 S Treatment of disseminated mycobacterial infections due to...
author: Darlene Norris
Fast Track Designated Products Approved since 1998 FAST TRACK DESIGNATED PRODUCTS APPROVED SINCE 1998 Through September 30, 2003 - NDA# NDA Drug Name Sponsor Applicant Approval Date Indication N020972 Sustiva (Efavirenz) 50/ 100/ 200MG Caps Dupont Pharms 9/17/98 Treatment of HIV N20977 Ziagen (Abacavir Sulfate) Tablets Glaxo Wellcome 12/17/98 Treatment of HIV N20978 Ziagen (Abacavir Sulfate) Oral Solution 12/17/98 N21007 Agenerase ...
author: Michael Lanthier
Research Reporting summer 2003b JANUARY 2003 Christine Chambers – The influence of developmental factors on children's accuracy on self- report scales for pain Anita Dircks – Evaluation of the triple marker maternal serum screen in assisted reproduction pregnancies Allaudin Ali Kamani – The determination of the correct dosage of phenylephrine and the development of an automatic drug delivery system...
author: dszeryk
subject: Research Reporting summer 2003b
NDA Approvals for Calendar Year 2001 Braun 5 S 21-Feb-01 21-235 Prozac Weekly Fluoxetine Hydrochloride Eli Lilly 3 S 26-Feb-01 21-169 Reminyl Galantamine Hydrobromide Janssen Research 1 S 28-Feb-01 21-082 Tavist Allergy/Sinus/Headache Acetaminophen/Clemastine Fumarate/Pseudoephedrine Hydrochloride Novartis 4 S 01-Mar-01 21-257 Travatan Travoprost Alcon 1 P 16-Mar-01 21-262 Alphagan P Brimonidine Tartrate Allergan 3 S 16...
author: Brenda Harmon
FDA Drug Approvals List May 2001 - Drug Approvals for May 2001 Definitions and Notes Original New Drug Applications Original Abbreviated Application # 075312 Approval Date: 31-MAY-01 Trade Name: FAMOTIDINE Dosage Form: TABLET Applicant: TEVA PHARMACEUTICALS USA INC Active Ingredient(s): FAMOTIDINE OTC/RX Status: OTC Original Abbreviated Application # 040419 Approval Date: 31-MAY-01 Trade Name: ACETAMINOPHEN AND...
FDA Drug Approvals List February 2002 - Drug Approvals for February 2002 Definitions and Notes Original New Drug Applications Original Application #: 020982 Approval Date: 12-FEB-02 Trade Name: PAXIL CR Chemical Type: 6 Therapeutic Potential: S Dosage Form: TABLET Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS Active Ingredient(s): PAROXETINE HYDROCHLORIDE OTC/RX Status: RX Indication(s): For the treatment of Panic...
Efficacy Supplements Approved in Calendar Year 2002 (SE1-SE7 AND SE8s EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2002 (SE1 -SE7)* and EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2002 (SE8)* - GENERIC NAME APPLICANT NDA NUMBER SUPP TYPE SUPP NUMBER RECEIPT DATE APPROVAL DATE PRIORITY REVIEW- TOTAL APPROVAL TIME (MONTHS) INDICATION/DESCRIPTION ANASTROZOLE ASTRAZENECA 20-541 SE1 010 5-Mar-02 5-Sep-02 Y 6.0 Provides for the use of ARIMIDEX ...
author: Darlene Norris
