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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...

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http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt
CHEM.WORKS OF G.R.,TRADED,MEDIMPEX HUNGARIAN TR.CO." 5605 09-Nov-84 SOCIETA ITALIANA MEDICINALI SCANDICCI (SIMS) METOPROLOL TARTRATE MFG IN THE FILARONE REGELLO (FLORENCE) FACILITY 5612 03-Dec-84 PCAS "TAMOXIFEN CITRATE MFG BY SIFA,LTD A SELOC AFFILIATE IN SHANNON,IRELAND" 5616 17-Oct-84 CIPLA LTD "DANAZOL USP AS MFG IN VIKHRELI,BOMBAY FACTORY" 5617 26-Oct-84 MORTON SALT CO DIV...

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http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls
PROPRANOLOL HCL TIANJIN MEDICINES & HEALTH PRODUCTS IMPORT AND EXPORT CO METHOCARBAMOL MFG BY XIN XIN PHARMACEUTICAL MANUFACTORY SOCIETA ITALIANA CORTICOSTEROIDI SPA BETAMETHASONE VALERATE INDUSTRIA CHIMICA MILANESE SPA THIORIDAZINE HYDROCHLORIDE INDUSTRIA CHIMICA MILANESE SPA FLUPHENAZINE HcL MALLINCKRODT INC THALLOUS CHLORIDE TI 201 INDUSTRIA CHIMICA MILANESE SPA PERPHENAZINE...

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Prescription and Over-the-Counter Drug Product List: 5/2003
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, APAP, AND CAFFEINE -A- AB AXIOM PHARM 325MG;50MG;40MG N89536 001 FEB 16, 1988 MAY CAHN -D- AB HALSEY 325MG;50MG;40MG N89536 001 FEB 16, 1988 MAY CAHN ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -A- AA ABLE 500MG;7.5MG...
author: AUTHOR
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1997 Abbreviated New Drug Applications (Generic Drugs)
Generic Drug Approval Packages These drug approval packages, sorted by product trade name, are supplied by the CDER Freedom of Electronic Information Office
074946 11/19/1997 3/30/1998 Adriamycin PFS (Doxorubicin Hydrochloride) Injection ,- Adria Laboratories 63165/S3, S5, S6 7/9/1993 8/8/2002 Albuterol Inhalation Aerolsol, 90 mcg/Actuation
64155, 64164, 64165, 64166 10/2/1997...
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Prescription and OTC Drug Product List 8/2001
ACTHAR GEL -D- BC + AVENTIS 40 UNITS/ML N08372 006 FEB 06, 1956 AUG CAHN -D- BC + 80 UNITS/ML N08372 008 FEB 06, 1956 AUG CAHN -A- BC + QUESTCOR PHARMS 40 UNITS/ML N08372 006 FEB 06, 1956 AUG CAHN -A- BC + 80 UNITS/ML N08372 008 FEB 06, 1956 AUG CAHN DELAVIRDINE MESYLATE TABLET; ORAL RESCRIPTOR -D- + AGOURON 100MG N20705 001 APR 04, 1997 AUG CRLD -A- 100MG N20705 001 APR 04, 1997 AUG...
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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
As adjunctive therapy in the...

author: Lee S. Ehler
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2003 Export Products List Alphabetical page 15


author: Lee S. Ehler
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Export Products List by System July 2003 page 41


author: Lee S. Ehler
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Export Products List by System July 2003 page 16


author: Lee S. Ehler
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Guideline on Validation of the Limulus Amebocyte Lysate Test As An End-Product Endotoxin Text for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices
Conc.( equine) 3.00 mL Dipyridamole 0.14 mg Dobutamine HCI 0.90 mg 5.00 1.10 2.17 3.57 1.80 1.80 1.80 1.80 45.45 5.00 1.25 5.56 11.60 + 0.50 + 35.70 + 71.43 16.70 + 17.20 + 0.70 + 0.70 + 111.00 + 200.00 + 1.00 357.00 0.003 + 0.50 + 166.67 1.00 4.00 0.50 + 1.00 8.77 3.40 + 16.67 1.67 37.70 5.56 40 Dopamine HCI Dopamine HCl in Dextrose Doxapram HCI Injection Doxorubicin HCI for...

author: FDA / CBER subject: December 1987 Guideline
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Guideline on Validation of the Limulus Amebocyte Lysate Test As An End-Product Endotoxin Text for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices page 8


author: FDA / CBER subject: December 1987 Guideline
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PDPL
- ADD - + ADV MAGNETICS EQ 11.2MG IRON/ML N20416 001 ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE - ADD - AUG 30, 1996 TABLET; ORAL-21 ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL 1/35-21 FLUPHENAZINE DECANOATE - DLT - AB WATSON LABS 0.035MG;1MG N72720 001 - DLT - DEC 30, 1991 INJECTABLE; INJECTION ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL 1/50-21 FLUPHENAZINE ...
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FDA Drug Approvals List- April 1998
Application #: 020555 Efficacy Supplement#: 003 Type: SE1 to Original New Drug Application Approval Date: 01-APR-98 Trade Name: AXID AR Dosage Form: TABLET Applicant: WHITEHALL ROBINS HEALTHCARE Active Ingredient(s): NIZATIDINE OTC/RX Status: OTC Efficacy Claim: Provides for treatment of episodic heartburn, acid indigestion and sour stomach Application #: 020393 Efficacy Supplement#:...
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I:<966APL.PDF
ANDA 74- 966 APR 16 1998 King Pharmaceuticals, Inc
Rogers, III 501 Fifth Street Bristol, TN 37620 Dear Sir: This is in reference to your abbreviated new drug application dated September 27, 1996, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act, for Fluphenazine Decanoate Injection USP, 25 mg/ mL (1 mL ampules and 5 mL multiple- dose...

author: Unknown
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I:<966APL.PDF page 1


author: Unknown
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DDPA August 1996
20-619 BETOPTICPILO ALCON BETAXOLOL HYDROCHLORIDE 01-AUG-96 (SUSPENSION) FORT WORTH, TX 0.25% 76134 PILOCARPINE HYDROCHORIDE 1.75% (ADRENOCEPTOR ANTAGONIST/ CHOLINERGIC AGONIST) 20-587 SCLEROSOL BRYAN TALC 09-AUG-96 (AEROSOL, POWDER) WOBURN, MA 4GM 01801 (MINERAL) 20-592 ZYPREXA LILLY OLANZAPINE 30-AUG-96 (TABLET) INDIANAPOLIS, IN 2.5MG 46285 5MG 7.5MG 10MG (ANTIPSYCHOTIC) **...
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Drug Approvals September 1996
CATARRHALIS TO THE INDICATIONS AND USAGE SECTION Approvable Original New Drug Applications Original Application #: 020535 Approvable Date: 30-SEP-96 Trade Name: DURACT Dosage Form: CAPSULE Applicant: WYETH AYERST LABORATORIES INC Active Ingredient(s): BROMFENAC SODIUM OTC/RX Status: RX Original Application #: 020690 Approvable Date: 19-SEP-96 Trade Name: ARICEPT Dosage Form: TABLET...
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August Drug Approvals
Original Application #: 020508 Approval Date: 29-AUG-96 Trade Name: LAC-HYDRIN Chemical Type: 3 Therapeutic Potential: S Dosage Form: CREAM Applicant: BRISTOL MYERS CO Active Ingredient(s): AMMONIUM LACTATE OTC/RX Status: RX Indication(s): ICHTHYOSIS VULGARIS AND XEROSIS Original Application #: 020532 Approval Date: 26-AUG-96 Trade Name: IVY BLOCK Chemical Type: 1 Therapeutic...
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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...
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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...
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Index F, 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 - INDEX - Index-A -~ Index-B -~ Index-C -~ Index-D -~ Index-E -~ Index-F-~ Index-G -~ Index-H -~ Index-I -~ Index-J -~ Index-K -~ Index-L -~ Index-M -~ Index-N -~ Index-O ...
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Schizophrenia: Schizophrenia and Delusional Disorder: Merck Manual Home Edition
Section Mental Health Disorders Subject Schizophrenia and Delusional Disorder Schizophrenia Schizophrenia is a mental disorder characterized by loss of contact with reality (psychosis), hallucinations (usually, hearing voices), delusions (false beliefs), abnormal thinking, flattened affect (restricted range of emotions), diminished motivation, and disturbed work and social...
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Schizophrenia: Schizophrenia and Delusional Disorder: Merck Manual Home Edition
Search Recent Searches Index Sections 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 Accidents and Injuries Blood Disorders Bone, Joint, and Muscle Disorders Brain, Spinal Cord, and Nerve Disorders Cancer Children's Health Issues Digestive Disorders Disorders of Nutrition and Metabolism Drugs Ear, Nose, and Throat Disorders Eye Disorders Fundamentals Heart and Blood Vessel...
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THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, OCUFEN to PYRIDIUM
Trade Names of Some Commonly Used Drugs TRADE AND GENERIC NAMES OF COMMONLY USED DRUGS OCUFEN to PYRIDIUM Trade Name Generic OCUFEN Flurbiprofen OCUPRESS Carteolol OMNIPEN Ampicillin ONCOVIN Vincristine OPHTHAINE Proparacaine OPHTHETIC Proparacaine ORETIC Hydrochlorothiazide ORETON Methyltestosterone ORINASE Tolbutamide ORUDIS Ketoprofen ORUVAIL Ketoprofen OXANDRIN Oxandrolone...
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