http://www.barrlabs.com/overview/annual/BRL_AR2001.pdf Barr Laboratories, Inc.Hydrochloride, the generic equivalent of Wyeth Ayerst Laboratories, Inc.Fluoxetine is the generic equivalent of...
http://www.barrlabs.com/overview/annual/BRL_AR2001.pdf page 46
http://www.barrlabs.com/overview/annual/BRL_AR2002.pdf Increased product sales were due mainly to new product launc es in fiscal 2002, including Fluoxetine, generic Adderall, new oral contraceptive products and increased sales of our Tamoxifen product.Fluoxetine were $ 367, 539, or 31% of product sales in fiscal 2002.Fluoxetine 20 mg...
Pages Chairman's Letter 3 Sales of Fluoxetine also decreased as expected, reflecting the impact of the introduction of additional generic versions of Fluoxetine by competitors upon expiration of our exclusivity period in January 2002.Fluoxetine and Tamoxifen was a 75% increase in sales of other products, led by higher sales...
author: Lisa
Pages page 23
author: Lisa
Prevention and cessation of cigarette smoking: control of tobacco use: Prevention - Health Professional Information [NCI PDQ] - Prevention and cessation of cigarette smoking: control of tobacco use: Prevention - Health Professional Information [NCI PDQ] This information is produced and provided by the National Cancer Institute (NCI).Hydrochloride Rx = prescription Brand Dose Side Effects Warning/Precaution Rx Zyban 150 mg/day X 3 days then increase to 300 mg/day X 7-12 weeks insomnia, dry...
BioPortfolio Limited Differentiation in Generic Products and Industry Innovators 17.1 Innovators in the New Generics Movement 17.2 Ivax 17.3 Andrx 17.3.1 Andrx and Generic Mevacor 17.3.2 Andrx and Generic Glucophage 17.4 Sicor 17.5 Watson Pharmaceuticals Box 6 Barr laboratories, Generic Fluoxetine and Generic Exclusivity Periods 18.
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...
Prescription and Over-the-Counter Drug Product List: 12/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, ACETAMINOPHEN AND CAFFEINE >A> + MIKART 750MG;50MG;40MG N40496 001 DEC 23, 2003 DEC NEWA ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE TABLET; ORAL DARVOCET A500 >D> + AAIPHARMA 500MG;100MG N76429 001 SEP 10, 2003 DEC CTNA >A> + 500MG;100MG N76429 001 SEP 10, 2003 DEC CTNA...
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,...
EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2003 FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - - EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2003 (SE1 -SE7)* and EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2003 (SE8)* - GENERIC NAME APPLICANT NDA NUMBER SUPP TYPE SUPP NUMBER RECEIPT DATE APPROVAL DATE PRIORITY REVIEW TOTAL APPROVAL TIME (MONTHS) INDICATION/DESCRIPTION ...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt 11956 09-May-96 MITSUBISHI CHEMICAL CORP "MKC-442 DRUG SUBSTANCE MANUFACTURED IN IBARAKI PREFECTURE, JAPAN." 11958 02-May-96 NYCOMED INC "METOLAZONE, USP MANUFACTURED IN RENSSELAER, NEW YORK." 11959 06-May-96 CHEMAGIS LTD "TRAMADOL HYDROCHLORIDE MANUFACTURED IN BEER SHEVA, ISRAEL." 11966 21-Feb-96 QUIMICA SINTETICA SA "CIPROFLOXACIN HYDROCHLORIDE (NEW SYNTHETIC PATHWAY)...
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
Welcome to Lilly UK - Prozac (Fluoxetine Hydrochloride ) Summary of Product Characteristics Click on one of the following links to go to the Electronic Medicine Compendium
Welcome to Lilly UK - Drug Name Generic Name Therapy Area Axid Nizatidine Gastrointestinal Disease Celance Pergolide mesilate Parkinson's disease Cialis Tadalafil Erectile Dysfunction Distaclor MR / Distaclor Cefaclor Infectious Diseases Evista Raloxifene Hydrochloride Osteoporosis Forsteo Teriparatide Osteoporosis Gemzar Gemcitabine Hydrochloride Cancer Humalog Human Insulin Analogue...
OGD Suitability Tracking Reports (Sorted by Petition Number) as of 1/5/2004 CLARK - INJECTION Approved 4/18/2000- THIOTEPA, STERILE 30 MG/VIAL - 00P-0092/CP1 GENSIA SICOR - FOR INJECTION Approved 6/14/2000- ALBUTEROL SULFATE 0.0417% - 00P-0913/CP1 MCDERMOTT, WILL AND EMERY - SOLUTION; INHALATION Approved 6/13/2000- CALCITONIN-SALMON 100 IU/ML-1ML VIALS - 00P-1213/CP1 FERRING PHARMACEUTICALS - INJECTION Approved 6/13/2000- ACETAMINOPHEN; 325 MG & 500MG/15 ML...
OGD Suitability Tracking Reports (Sorted by Drug Name) as of 1/5/2004 - SOLUTION; TOPICAL Approved 1/8/2002- FLUOXETINE 20 MG & 40 MG - 01P-0243/CP1 Cipher Pharmaceuticals LtdFLUOXETINE 40 MG - 00P-1365/CP1 LACHMAN CONSULTANT SERVICES - TABLET; ORAL Approved 1/12/2001- GABAPENTIN 100MG,300MG,400MG - 00P-1419/CP1 LACHMAN CONSULTANT SERVICES - TABLET; ORAL Approved 1/12/2001- GANCICLOVIR SODIUM 500 MG...
Cancer.gov - Smoking Cessation and Continued Risk in Cancer Patients (PDQ®) Date Last Modified:--10/23/2003 - - Smoking Cessation and Continued Risk in Cancer Patients Overview Smoking as a Primary Risk Factor Poorer Treatment Response in Cancer Patients Smoking as a Risk for Second Malignancy Effects of a Cancer Diagnosis on Quitting Smoking and Remaining Abstinent Smoking Intervention With Cancer Patients Pharmacological Treatment Bupropion ...
Cancer.gov - Prevention and Cessation of Cigarette Smoking: Control of Tobacco Use (PDQ®) Prevention and Cessation of Cigarette Smoking: Control of Tobacco Use (PDQ®) Two versions of this document are availableHydrochloride A- BrandA- DoseA- Side EffectsA- Warning/precaution A- Rx = prescription RxA- Zyban A- 150 mg/day X 3 days then increase to 300 mg/day X 7-12 weeksA- insomnia, dry mouth, dizziness, rhinitisA- *do not take with Wellbutrin or...
OGD, Tentative Approvals September 2000 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Office of Generic Drugs ANDAs Tentative Approvals - September 2000 Page: 1 Friday, October 06, 2000 1FLUOXETINE HYDROCHLORIDE NOVEX PHARMA 9/1/00 ORAL SOLUTION 20 MG (BASE)/5 mL 2
author: USERNAME
ANDA Tentative Approvals -May 2001 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Tentative Approvals - May 2001 - ANDA Number Drug Name Applicant Tentative Approval Date 1 75-410 OMEPRAZOLE DELAYED-RELEASE CAPSULES 10 MG, AND 20 MG KREMERS URBAN DEVELOPMENT COMPANY 5/3/01 2 75-521 BUSPIRONE HYDROCHLORIDE TABLETS USP 5 MG, 10 MG, AND 15 MG TORPHARM 5/9/01 3 75...
author: USERNAME
ANDA Tentative Approvals -June 2001 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Tentative Approvals - June 2001 - ANDA Number Drug Name Applicant Tentative Approval Date 1 75-727 ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE TABLETS, USP 5 MG/12.5 MG, AND 10 MG/25 MG TEVA PHARMACEUTICALS USA 6/8/01 2 75-743 LISINOPRIL TABLETS, USP 2.5 MG, 5 MG, 10 MG, 20 MG, 30 MG,...
author: USERNAME
ANDA Tentative Approvals -August 2001 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Tentative Approvals - August 2001 - - ANDA Number Drug Name Applicant Tentative Approval Date 1 75-852 MILRINONE LACTATE INJECTION 1 MG (BASE)/ML BAXTER PHARMACEUTICAL PRODUCTS, INCHYDROCHLORIDE TABLETS, USP 15 MG (NOTE: 5 MG & 10 MG STRENGTHS WERE...
author: USERNAME
First-Time Generics - August 2001 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search First-Time Generics - August 2001 - Approval Date Drug Name ANDA Number 8/2/01 FLUOXETINE ORAL SOLUTION, USP 20 MG/5 ML 75-506 8/2/01 FLUOXETINE CAPSULES, USP 20 MG 74-803 8/2/01 FLUOXETINE CAPSULES, USP 40 MG 75-465 8/2/01 FLUOXETINE HYDROCHLORIDE TABLETS...
author: USERNAME
ANDA Tentative Approvals -September 2001 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Tentative Approvals - September 2001 - - ANDA Number Drug Name Applicant Tentative Approval Date 1 76-071 LISINOPRIL TABLETS, USP 2.5 MG, 5 MG, 10 MG, 20 MG, 30 MG, AND 40 MG MYLAN PHARMACEUTICALS INCFLUOXETINE CAPSULES, USP 10 MG, AND 20 MG EON LABS...
author: USERNAME
