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3.3.1 Age 3.3.2 A possible genetic basis to PD 3.3.3 Men are more likely to develop PD 3.3.4 Pesticides and Herbicides influence PD Development 3.3.5 Reduced Oestrogen Levels Increase the Risk of PD 3.3.6 Reduced Folate Levels Associated with PD 3.4 Demographics of PD Table 3.1 Demographic Facts of PD Worldwide 3.5 Financial Burden of PD 3.6 Pathophysiology of PD 3.7 The Market...
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Drug Approvals - A
NDA 18-761/S16 1/23/02 2/5/02 - - Amantadine Hydrochloride Syrup USP, 50 mg/5 mL, Rx Carolina Medical Products Co
ANDA 75-819 9/11/02 Amantadine Hydrochloride Syrup USP, 50 mg and 5 mL Morton Grove Pharmaceuticals ANDA 75-060 12/24/98 12/24/98 - - Amantadine Hydrochloride Tablets, 100 mg, Rx Upsher-Smith Laboratories, Inc
NDA 5-619/S-016 3/30...
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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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http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt
IN LUBECK, GERMANY" 9665 28-Apr-92 NORTHEAST GENERAL PHARMACEUTICAL FACTORY "AMANTADINE HYDROCHLORIDE MFG
OF IRELAND" 13266 05-Oct-98 FABBRICA ITALIANA SINTETICI SPA "NITROFURANTOIN MONHYDRATE, MANUFACTURED IN VICENZA, ITALY" 13277 22-Oct-98 MATRIX LABORATORIES LIMITED "ACYCLOVIR USP, MANUFACTURED IN ANDHRA PRADESH, INDIA" 13279 19-Oct-98 SYLACHIM DIV FINORGA ...

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Flu Drugs
Food and Drug Administration • Center for Drug Evaluation and Research Influenza Information Search Influenza Antiviral Drugs and Related Information Introduction Influenza Vaccine Information -- Drug Information - Influenza Information from Other Web Sites Contacts For More Information Introduction -- The term -influenza- refers to illness caused by influenza virus
The...
author: Winthrop
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Prescription and Over-the-Counter Drug Product List: 4/2003
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL FIORICET -D- AB + NOVARTIS 325MG;50MG;40MG N88616 001 NOV 09, 1984 APR CAHN -A- AB + WATSON PHARMS 325MG;50MG;40MG N88616 001 NOV 09, 1984 APR CAHN ACYCLOVIR CAPSULE; ORAL ACYCLOVIR -A- AB AAIPHARMA 200MG N74833 001 APR 22, 1997 APR CAHN -D- AB AESGEN 200MG N74833 001 APR 22, 1997...
author: AUTHOR
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Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - September 2002 - ANDA Number Generic Drug Name Applicant Approval Date 1 65-058 CEFACLOR EXTENDED-RELEASE TABLETS, USP 375 MG 500 MG TEVA PHARMACEUTICALS USA 9/4/02 2 75-163 TIMOLOL MALEATE OPHTHALMIC SOLUTION, USP 0.5% (BASE) HI-TECH PHARMACAL CO., INC
9/10/02 3 75-893...
author: USERNAME
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First-Time Generics - December 2002
Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search First-Time Generics - December 2002 - Generic Drug Name Generic Manufacturer Brand Name Approval Date 1 AMANTADINE HYDROCHLORIDE TABLETS 100 MG UPSHER-SMITH LABORATORIES, INC
SYMMETREL TABLETS 12/16/02 2 DILTIAZEM HYDROCHLORIDE FOR INJECTION 100 MG ADD-VANTAGE...
author: OGD
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ANDA Approvals December 2002
Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - December 2002 - ANDA- Number Generic Drug Name Applicant Approval Date 1 65-116 BACITRACIN FOR INJECTION, USP 50,000 UNITS/VIAL AMERICAN PHARMACEUTICAL PARTNERS, INC
12/16/02 6 76-186 AMANTADINE HYDROCHLORIDE TABLETS 100 MG UPSHER-SMITH LABORATORIES, INC author: OGD
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6444-04 Amantadine PI.qxd page 2


author: ian oldham
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6444-04 Amantadine PI.qxd page 1


author: ian oldham
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Symmetrel PI 6475-05 .qxd page 2


author: ian oldham
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Symmetrel PI 6475-05 .qxd page 1


author: ian oldham
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C:\Wheelous\NDA\17118 Symmetrel\S017 APPROVAL LETTER.doc
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 NDA 17- 118/ S- 017 Endo Pharmaceuticals Attention: Robert A
Barto: Please refer to your supplemental new drug application dated February 11, 2003 received February 13, 2003, submitted under section 505( b) of the Federal Food, Drug, and Cosmetic Act for Symmetrel (...

author: Teresa Wheelous
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C:\Wheelous\NDA\17118 Symmetrel\S017 APPROVAL LETTER.doc page 1


author: Teresa Wheelous
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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;...
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Prescription and OTC Drug Product List 9/2002
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST -A- ADEFOVIR DIPIVOXIL -A- TABLET; ORAL -A- HEPSERA -A- + GILEAD 10MG N21449 001 SEP 20, 2002 SEP NEWA ALBUTEROL SULFATE TABLET, EXTENDED RELEASE; ORAL -A- ALBUTEROL SULFATE -A- AB SIDMAK LABS EQ 4MG BASE N76130 002 SEP 26, 2002 SEP NEWA -A- AB EQ 8MG BASE N76130 003 SEP 26, 2002 SEP NEWA VOLMAX -D- BC + MURO EQ 4MG BASE N19604...
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2003 Export Products List Alphabetical
Page: 1 5760627132 pms- Acetaminophen 80mg/ 5mL Oral Solution 100mL Atasol / Tylenol / Tempra Analgesic / Antipyretic: As a non- salicylate analgesic- antipyretic for temporary relief of mild to moderate pain in a wide variety of conditions, including headache, earache, muscle strain, bursitis, sprains, menstrual cramps and musculoskeletal pain
ADULTS 5760604034 pms- Amantadine...

author: Lee S. Ehler
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2003 Export Products List Alphabetical page 2


author: Lee S. Ehler
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Export Products List by System July 2003 page 40


author: Lee S. Ehler
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Export Products List by System July 2003 page 28


author: Lee S. Ehler
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http://www.fda.gov/cder/foi/label/2001/17938s22lbl.PDF
ENDO LABORATORIES MOBAN ® (Molindone Hydrochloride) Rx only DESCRIPTION MOBAN (molindone hydrochloride) is a dihydroindolone compound which is not structurally related to the phenothiazines, the butyrophenones or the thioxanthenes
MOLINDONE HYDROCHLORIDE CLINICAL PHARMACOLOGY MOBAN has a pharmacological profile in laboratory animals which predominantly resembles...

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SSCI Inc.: X-ray Powder Diffraction, Raman and Infrared Spectroscopy, Differential Scanning Calorimetry, and Thermogravimetric
Phone: 800 375-2179 / 765 463-0112 Fax: 765 497-2649 / 765 463-4722 E-mail: info@ssci-inc.com SSCI Inc., 3065 Kent Avenue, West Lafayette, IN 47906 - 1076 USA Acetaminophen Acetazolamide Acetohexamide Acetylcysteine Acyclovir Adenine L-Alanine Albuterol Albuterol Sulfate Allopurinol Alprazolam Amantadine HCl Amiloride HCl Aminobenzoic Acid Aminoglutethimide Aminosalicylic Acid...
author: SSCI Webmaster
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Prescription and OTC Drug Product List 11/1997
Prescription and Over-the-Counter Drug Product List - 17th Edition Cumulative Supplement Number 11: Jan '97 - Nov '97 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACARBOSE AMANTADINE HYDROCHLORIDE TABLET; ORAL CAPSULE; ORAL PRECOSE - DLT - SYMADINE - DLT - BAYER 25MG N20482 004 - DLT - AB SOLVAY 100MG N71000 001 - DLT - MAY 29, 1997 - DLT ...
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Prescription and OTC Drug Product List 12/1998
Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 12: December 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST - ADD - ABACAVIR SULFATE ALBUTEROL SULFATE - ADD - SOLUTION; ORAL SOLUTION; INHALATION - ADD - ZIAGEN ALBUTEROL SULFATE - ADD - + GLAXO WELLCOME EQ 20MG BASE/ML N20978 001 - ADD - @ COPLEY PHARM...
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