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http://www.barrlabs.com/overview/annual/BRL_AR2001.pdf
Barr Laboratories, Inc.
This case involves raw material patents.
Downey Chairman 6 This year, we will add the challenge of integrating our Company with Duramed to the commitments that I am asking our employees to make.
In January 2001, we received approval for Amiodarone Hydrochloride, the generic equivalent of Wyeth Ayerst Laboratories, Inc.
Florida Consumers...
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Paragraph IV Patent Certifications
- DRUG NAME DOSAGE FORM STRENGTH RLD Acetaminophen Extended-release Tablets 650 mg Tylenol Acetaminophen/ Aspirin/ Caffeine Tablets 250 mg/250 mg/ 65 mg Excedrin (migraine) Acetaminophen and Tramadol Hydrochloride Tablets 325 mg/ 37.5 mg Ultracet Acyclovir Sodium1 Injection 50 mg/mL, 10 mL and 20 mL vials Zovirax Albuterol Sulfate Oral Syrup 2 mg(base)/ 5 mL Ventolin Albuterol...
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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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http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt
CHICAGO, ILL FACIL" 4537 07-Apr-82 DIPHARMA FRANCIS SPA HYDROFLUMETHIAZIDE USP 4538 07-Apr-82 RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA DIPHENYLHYDANTOIN SODIUM SALT 4539 17-May-82 R MASON CHEMICALS LTD SELENIUM DISULFIDE 4555 17-Mar-82 AJINOMOTO USA INC "AMINO ACIDS MANUFACTURED IN RALEIGH, NORTH CAROLINA." 4561 12-May-82 FINE CHEMICALS CORPORATION VINCRISTINE SULPHATE...
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http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls
URSODEOXYCHOLIC ACID MEDIMPEX INC ALPHA METHYLDOPA USP XIX BULK AS MFG BY EGIS PHARMACEUT WORKS BUDAPEST ACRAF TRAZODONE HCL ROCHE COLORADO CORPORATION BUTOCONAZOLE NITRATE GEDEON RICHTER LTD NORETHISTERONE DINAMITE DIPHARMA SPA FUROSEMIDE USP SCHERING AG ESTRADIOL-VALERATE SCHERING AG TESTOSTERONE ENANTHATE PROQUINA SA PIPERAZINE ESTRONE SULFATE MERCK AG METHYL GLUCAMINE ...
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1997 Abbreviated New Drug Applications (Generic Drugs)
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
64136 9/30/96 4/13/99 Clomipramine Hydrochloride [2 MB] Taro Pharmaceuticals 074694 12/13/1996 12/3/1997 Clomipramine Hydrochloride Capsules, 25, 50, & 75 mg
74-648 3/18/97 4/8...
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Quartely List of Guidance Documents at the Food and Drug Administration page 12
author: FDA
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Comprehensive List of Current Guidance Documents at the Food and Drug Administration page 31
author: FDA
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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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http://www.fda.gov/cber/gdlns/guidelst.txt
Drug Advertising and Promotional Labeling DDMAC 2 Dissemination of Reprints of Certain October 8, 1996 Advertising Do Published, Original Data Funded Dissemination of Reference October 8, 1996 Do Do Texts Antifungal (topical) February 24, 1990 Biopharmaceutic Drug Information Branch (Draft) Antifungal (vaginal) February 24, 1990 Do Do Food-Effect Bioavailability and December 30, 1997...
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http://www.fda.gov/cber/gdlns/qrtrgde.txt
Guidance Documents Issued by the Center for Drug Evaluation and Research (CDER) ---------------------------------------------------------------------------------------------------------------- How to Obtain a Hard Grouped by Intended Copy of the Document Name of Document Date of Issuance User or Regulatory (Name and Address, Activity Phone, FAX, E-mail or Internet) ------------------...
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DDPA December 1995
20-545 PROCANBID PARKE DAVIS PROCAINAMIDE HYDROCHLORIDE 14-DEC-95 (TABLET, ANN ARBOR, MI 500MG EXTENDED RELEASE) 48106 1000MG (ANTIARRHYTHMIC) 20-518 RETROVIR GLAXO WELLCOME ZIDOVUDINE 19-DEC-95 (TABLET) RES TRIANGLE PK, NC 300MG 27709 (ANTIVIRAL) 20-535 BROMFENAC SODIUM WYETH AYERST BROMFENAC SODIUM 28-DEC-95 (CAPSULE) RADNOR, PA EQ 25MG BASE 19087 EQ 50MG BASE (NONSTEROIDAL...
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http://www.fda.gov/cder/da/ddpa93.wpd
20 142 CATAFLAM GEIGY DICLOFENAC POTASSIUM 03 30 93 (TABLET) SUMMIT, NJ 25MG 07901 50MG (NONSTEROIDAL ANTI-INFLAMMATORY) 73 535 PIROXICAM MUTUAL PHARM PIROXICAM 03 12 93 (CAPSULE) PHILADELPHIA, PA 10MG 19124 (NONSTEROIDAL ANTI-INFLAMMATORY) 73 536 PIROXICAM MUTUAL PHARM PIROXICAM 03 12 93 (CAPSULE) PHILADELPHIA, PA 20MG 19124 (NONSTEROIDAL ANTI-INFLAMMATORY) 73 136 TRAZODONE...
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http://www.fda.gov/cder/da/ddpa91.wpd
19 531 NUTRILI 10% MCGAW SOYBEAN OIL 02 08 91 (INJECTABLE) IRVINE, CA 10% 92713 (NUTRIENT REPLENISHER) 19 531 NUTRILI 20% MCGAW SOYBEAN OIL 02 08 91 (INJECTABLE) IRVINE, CA 20% 92713 (NUTRIENT REPLENISHER) 20-069 DIANEAL PD-2 BAXTER CALCIUM CHLORIDE 02-19-91 ELECTROLYTE ROUND LAKE, IL 514MG/100ML CONCENTRATE 60073 MAGNESIUM CHLORIDE IN PLASTIC CONTAINER 102MG/100ML (SOLUTION) SODIUM...
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http://www.barrlabs.com/overview/annual/BRL_AR2001.pdf page 28
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http://www.barrlabs.com/overview/annual/BRL_AR2001.pdf page 27
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http://www.barrlabs.com/overview/annual/BRL_AR2002.pdf page 23
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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 T, 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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Insomnia, Sleep, 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 - SECTION 3 Medical Conditions CHAPTER 31 - Sleep TOPICS - Introduction -~ Insomnia-~ Excessive Daytime Sleepiness -~ Limb Movement Disorders -~ Sleep Apnea -~ REM Sleep...
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Depression: Depression and Mania: Merck Manual Home Edition
Section Mental Health Disorders Subject Depression and Mania Depression Depression is a feeling of intense sadness; it may follow a recent loss or other sad event but is out of proportion to that event and persists beyond an appropriate length of time.
Transient depression is when someone becomes temporarily depressed in reaction to certain holidays (holiday blues) or meaningful...
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THE MERCK MANUAL, Sec. 22, Ch. 304, Drug Therapy In The Elderly
This Publication Is Searchable The Merck Manual of Diagnosis and Therapy--- Section 22.
Antihypertensives: Treatment of hypertension is effective in older patients; recent analysis of several studies indicates that only 18 older patients must be treated for 5 yr to prevent one cardiovascular event.
Antiparkinsonian drugs: Levodopa clearance is reduced in older patients, who are...
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THE MERCK MANUAL, Sec. 15, Ch. 189, Mood Disorders
This Publication Is Searchable The Merck Manual of Diagnosis and Therapy--- Section 15.
The diagnosis of clinical depression is usually straightforward, but recognizing low-grade symptoms may be difficult.
Stimulation of 5-HT1 receptors is associated with antidepressant and anxiolytic effects.
Trazodone, an antidepressant related to nefazodone, is a 5-HT2 receptor...
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THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, DALMANE to FURADANTIN
Trade Names of Some Commonly Used Drugs TRADE AND GENERIC NAMES OF COMMONLY USED DRUGS DALMANE to FURADANTIN Trade Name Generic DALMANE *Flurazepam DANOCRINE Danazol DANTRIUM Dantrolene DARAPRIM Pyrimethamine DARBID Isopropamide DARVON *Propoxyphene DAYPRO Oxaprozin DDAVP Desmopressin DECADRON Dexamethasone DECLOMYCIN Demeclocycline DELALUTIN Hydroxyprogesterone DELATESTRYL...
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