Drug Approvals - N ANDA 75-274 5/26/99 6/1/99 - 7/11/01 Namenda (Memantine Hydrochloride) Tablets, Forest Laboratories NDA 21-487 10/16/03 10/22/03 10/20/03 12/30/03 Naprosyn (naproxen), Suspension and Anaprox (naproxen sodium), Rx Syntex Development Research NDA 17-581/S-098, 18-965/S-007 & 18-164/S-049 4/14/03 Naproxen Delayed-release Tablets, 375 mg & 500 mg
http://www.fda.gov/cder/orange/appendix_a.txt 1/35 28, ETHINYL ESTRADIOL NABUMETONE, NABUMETONE NADOLOL, NADOLOL NAFAZAIR, NAPHAZOLINE HYDROCHLORIDE NAFCILLIN SODIUM, NAFCILLIN SODIUM NAFTIN, NAFTIFINE HYDROCHLORIDE NALBUPHINE HCL, NALBUPHINE HYDROCHLORIDE NALBUPHINE, NALBUPHINE HYDROCHLORIDE NALFON 200, FENOPROFEN CALCIUM NALFON, FENOPROFEN CALCIUM NALIDIXIC ACID, NALIDIXIC ACID APPENDIX A PRODUCT NAME...
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
Prescription and Over-the-Counter Drug Product List: 10/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN >A> AA VINTAGE PHARMS 500MG/15ML;7.5MG/15ML N40520 001 OCT 30, 2003 OCT NEWA TABLET; ORAL ANEXSIA >D> AA MALLINCKRODT 750MG;10MG N40468 001 OCT 31, 2002 OCT CTNA >A> AA 750MG;10MG N40468 001 OCT 31, 2002 OCT CTNA ALBUTEROL SULFATE TABLET...
NTII - Neurobiological Technologies, Inc. About NTI -|- Corporate Directory -|- Legal - XERECEPT® Trial for Peritumoral Brain Edema About NTI Neurobiological Technologies, Inc.
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...
Alzheimer's Disease - Quest Diagnostics Patient Health Library Alzheimer's Disease Medications At this time, there are no medications that can prevent or cure Alzheimer's disease or that will restore normal mental abilities.Namenda) ...
Alzheimer's Disease - Quest Diagnostics Patient Health Library Alzheimer's Disease Treatment Overview While there is not yet a cure for Alzheimer's disease , there is much that can be done to maintain quality of life, and help the person stay active.Namenda), may be used alone or with cholinesterase inhibitors to treat moderate to severe symptoms of confusion and memory loss caused by Alzheimer's disease....
ANNUAL REPORT FOR SMALL BUSINESS ISSUERS SUBJECT page 18
author: Michael R. Espey
duplicates:http://www.axonyx.com/pdf/axonyx_form10k_20040330.pdf
http://www.axonyx.com/pdf/form_10k_20041231.pdf page 15
Database M M - 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.
Database N N - 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.
Drug Approval Package FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Namenda (Memantine HCI) Tablets Company:- Forest Laboratories Inc
Pharmaceutical Research and Manufacturers of America - Forest Laboratories Complete a new search Drug Name (Proprietary name/Generic name) Indications Addressed Click on indication to see all drugs for that indication Company Click a company to see all drugs for that company Development Status Notes acamprosate none / none Alcohol Dependence Forest Laboratories New York, NY application submitted - Aerobid Aerobid / flunisolide...
Pharmaceutical Research and Manufacturers of America Laurent, Quebec Phase III - APAN-1 none / APAN-1 Alzheimer's Disease Praecis Pharmaceutical Waltham, MA Phase I - Aricept none / donepezil HCI Alzheimer's Disease Attention Deficit/Hyperactivity Disorder Migraine Headache Mild Cognitive impairment Eisai Teaneck, NJ Phase IIII/ Phase II/III/ Phase II 7 years-16 years - breaker peptide none / none Alzheimer's Disease Serono Norwell, MA...
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http://www.fda.gov/cder/foi/label/2003/021487lbl.pdf The curves show that both patients assigned to NAMENDA/ donepezil and placebo/ donepezil have a wide range of responses and generally show deterioration, but that the NAMENDA/ donepezil group is more likely to show a smaller decline or an improvement Approval Labeling Text NDA 21- 487 Page 10 0 10 20 30 40 50 60 70 80 90 100 0 5 10 15 ADCS- ADL Change from Baseline...
http://www.fda.gov/cder/foi/label/2003/021487lbl.pdf page 19
http://www.fda.gov/cder/foi/label/2003/021487lbl.pdf page 15
http://www.fda.gov/cder/foi/label/2003/021487lbl.pdf page 14
http://www.fda.gov/cder/foi/label/2003/021487lbl.pdf page 3
http://www.fda.gov/cder/foi/label/2003/021487lbl.pdf page 2
http://www.fda.gov/cder/foi/label/2003/021487lbl.pdf page 1
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...
