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http://www.fda.gov/cder/orange/appendix_a.txt
2, BUTABARBITAL SODIUM SARISOL, BUTABARBITAL SODIUM APPENDIX A PRODUCT NAME INDEX SATRIC, METRONIDAZOLE SCABENE, LINDANE SCANDONEST L, LEVONORDEFRIN SCANDONEST PLAIN, MEPIVACAINE HYDROCHLORIDE SCLEROSOL, TALC SCRUBTEAM SURGICAL SPONGEBRUSH, HEXACHLOROPHENE SEASONALE, ETHINYL ESTRADIOL SECOBARBITAL SODIUM, SECOBARBITAL SODIUM SECONAL SODIUM, SECOBARBITAL SODIUM SECREFLO,...
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BioPortfolio Limited
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
ANDA 76-088 7/17/02 - - - Amiodarone Hydrochloride Injection, 50 mg/mL, Rx Bedford Laboratories ANDA 76-018 10/15/02 - - - Amiodarone Hydrochloride Injection, 50 mg/mL, Rx Tentatively Approved Bedford Laboratories ANDA 76-018 5/7/02 - - - Amiodarone Hydrochloride Injection, 50 mg/mL, Rx Abbott Laboratories ANDA 75-955 10/18/02 Amiodarone Hydrochloride...
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http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt
(TRIHEXYPHENIDYL HCL.) 2698 21-Jun-76 SIEGFRIED LTD
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 "LEVOBETAXOLOL HYDROCHLORIDE, MANUFACTURED IN CHASSE-SUR-RHONE,...
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http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls
IN BUDAPEST, HUNGARY PLANTEX LTD CHEM AND PHARM WORKS IMIPRAMINE HYDROCHLORIDE LUNDBECK PHARMACEUTICALS ITALY SPA IMIPRAMINE HYDROCHLORIDE AVENTIS PHARMA SA PROMETHAZINE HCL GRUPPO LEPETIT SPA D-PROPOXYPHENE HYDROCHLORIDE BULK SCHERING AG ETHINYL ESTRADIOL ROCHE COLORADO CORPORATION
BISACODYL ROCHE DIAGNOSTICS GMBH DIGOXIN PRODUCTS SOLMAG S.P.A DICYCLOMINE ...
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Prescription and Over-the-Counter Drug Product List: 11/2003
ACTHAR GEL >D> BC + QUESTCOR PHARMS 80 UNITS/ML N08372 008 NOV CTEC >A> + 80 UNITS/ML N08372 008 NOV CTEC CYTARABINE INJECTABLE; INJECTION >D> CYTARABINE >D> AP + GENSIA SICOR PHARMS 100MG/VIAL N16793 001 NOV DISC >D> AP + 500MG/VIAL N16793 002 NOV DISC >D> AP + 1GM/VIAL N16793 003 DEC 21, 1987 NOV DISC >D> AP + 2GM/VIAL N16793 004 DEC 21, 1987 NOV DISC >A> @ SICOR PHARMS 100MG/VIAL...
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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
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Prescription and OTC Drug Product List 11/2001
IRRIGANT -D- MONARCH PHARMS EQ 40MG BASE/ML;200,000 UNITS/ML N60707 001 JUN 28, 1966 NOV CRLD -A- + EQ 40MG BASE/ML;200,000 UNITS/ML N60707 001 JUN 28, 1966 NOV CRLD OMEPRAZOLE CAPSULE, DELAYED REL PELLETS; ORAL -A- OMEPRAZOLE -A- AB ANDRX PHARMS 10MG N75347 001 NOV 16, 2001 NOV NEWA -A- AB 20MG N75347 002 NOV 16, 2001 NOV NEWA -A- AB 40MG N75347 003 NOV 16, 2001 NOV NEWA -A-...
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http://www.fda.gov/cder/foi/appletter/2003/06773slr036ltr.pdf page 1
author: DAVID
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FDA Drug Approvals List February 2000
- Drug Approvals for February 2000 Definitions and Notes Original New Drug Applications Original Application #: 021015 Approval Date: 28-FEB-00 Trade Name: ANDROGEL Chemical Type: 3 Therapeutic Potential: S Dosage Form: GEL Applicant: UNIMED PHARMACEUTICALS INC Active Ingredient(s): TESTOSTERONE OTC/RX Status: RX Indication(s): For replacement therapy in males for conditions...
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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 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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Prescription and OTC Drug Product List 9/1999
Prescription and Over-the-Counter Drug Product List - 19th Edition Cumulative Supplement Number 9: September 1999 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE ATENOLOL CAPSULE; ORAL TABLET; ORAL - DLT - BUTALBITAL, ACETAMINOPHEN, CAFFEINE ATENOLOL - DLT - AB GRAHAM DM 325MG;50MG;40MG N88758 001 - ADD - MYLAN 25MG...
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Prescription and OTC Drug Product List 2/2000
Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 2: February 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE CICLOPIROX TABLET; ORAL CREAM; TOPICAL LORTAB LOPROX - DLT - UCB 325MG;5MG N40099 001 - ADD - + AVENTIS PHARMS 0.77% N18748 001 - DLT - JUN 25, 1997 - ADD -...
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Drug Approvals for April 1997
Drug Approvals for April 1997 Definitions and Notes April 1997 Original New Drug Applications Original Application #: 020619 Approval Date: 17-APR-97 Trade Name: BETOPTIC PILO Chemical Type: 4 Therapeutic Potential: S Dosage Form: SUSPENSION/DROPS Applicant: ALCON LABORATORIES INC Active Ingredient(s): BETAXOLOL HYDROCHLORIDE; PILOCARPINE HYDROCHLORIDE OTC/RX Status: RX...
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FDA Drug Approvals List- February 1998
Drug Approvals for February 1998 Definitions and Notes February 1998 Original New Drug Applications Original Application #: 050750 Approval Date: 24-FEB-98 Trade Name: ZOSYN Chemical Type: 3 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: LEDERLE PIPERACILLIN INC DIV AMERICAN CYANAMID CO Active Ingredient(s): PIPERACILLIN SODIUM; TAZOBACTAM SODIUM OTC/RX Status: RX...
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http://www.fda.gov/cder/foi/appletter/2000/40337ltr.pdf
ANDA 40- 337 February 16, 2000 West- ward Pharmaceutical Corp
Vasquez 435/ 465 Industrial Way West Eatontown, NJ 07724 Dear Madam: This is in reference to your abbreviated new drug application dated October 9, 1998, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act (Act), for Trihexyphenidyl Hydrochloride Tablets USP, 2 mg and 5 mg
We...
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http://www.fda.gov/cder/foi/appletter/2000/40337ltr.pdf page 1
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FDA Drug Approvals List August 1999
Application #:020547Efficacy Supplement#:007 Type: SE1 to Original New Drug Application Approval Date: 17-SEP-99 Trade Name: ACCOLATE Dosage Form: TABLET Applicant: ZENECA LTD Active Ingredient(s): ZAFIRLUKAST OTC/RX Status: RX Efficacy Claim: For the prophylaxis and chronic treatment of asthma in pdiatric patients 7-11 years of age Application #: 20711 Efficacy Supplement#: 003 Type...
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http://www.fda.gov/cder/foi/appletter/1999/40251ltr.pdf page 1
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FDA Drug Approvals List- December 1998
Drug Approvals for December 1998 Definitions and Notes December 1998 Original New Drug Applications Original Application #: 020998 Approval Date: 31-DEC-98 Trade Name: CELEBREX Chemical Type: 1 Therapeutic Potential: P Dosage Form: CAPSULE Applicant: GD SEARLE AND CO Active Ingredient(s): CELECOXIB OTC/RX Status: RX Indication(s):For the signs and symptoms of osteoarthritis and...
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H: 54AP.PDF
ANDA 40- 254 December 24, 1998 Vintage Pharmaceuticals, Inc
Charlotte, NC 28206 Dear Madam: This is in reference to your abbreviated new drug application dated April 28, 1997, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act, for Trihexyphenidyl Hydrochloride Tablets USP, 2 mg and 5 mg
We have completed the review of this abbreviated...
author: Unknown
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H: 54AP.PDF page 1
author: Unknown
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