BioPortfolio Limited
8.5 Diagnosis of Neuropathy 8.6 The Classifications of Neuropathy 8.6.1 Diabetic Neuropathy 8.6.2 Auto-Immune Disease Related and its Relationship with Neuropathic Pain 8.6.3 Chemotherapy-Induced Neuropathy 8.6.4 Drug-Related Neuropathy 8.7 The Societal Impact of Neuropathy 8.8 The Cost of Neuropathic Pain Table 8.1 The Annual Cost of Pain 8.9 Current Treatment of Neuropathy 8.10 Non...
BioPortfolio Limited
Prescription Generics Report 2003 - 2011 1. 7.2 What are the Grounds for the Provision of a Compulsory License? Pharmaceutical Manufacturers and the Policy Makers 15.1 Lobbying by Brand-Name and GenericPharmaceutical Companies 15.2 The Importance of Lobbying in the U.S.Pharmaceutical Industry 15.3 Successful Lobbying and Continued Exclusivity with Paediatric Safety Testing 15.4...
Teva Pharmaceutical Industries - News and PR
- - Search Tevapharm: - - Press Release Teva Announces Approvable Status of ANDA for Tramadol HCl Tablets Jerusalem, Israel, January 17, 2002 - Teva Pharmaceutical Industries Ltd. Food and Drug Administration has granted approvable status for Tramadol Hydrochloride Tablets, 50 mg.Tramadol Hydrochloride Tablets are the AB-rated generic...
Teva Pharmaceutical Industries - News and PR
- - Search Tevapharm: - - Press Release Teva Announces Approval of Tramadol HCl Tablets Jerusalem, Israel, June 20, 2002 - Teva Pharmaceutical Industries Ltd. Food and Drug Administration has granted final approval of the companys ANDA for Tramadol Hydrochloride Tablets, 50 mg.Tramadol Hydrochloride Tablets are the AB-rated generic version...
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...
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,...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt
LISINOPRIL CRUDE AS MFG IN COURBEVOIE AND HAM FRANCE 14537 19-Nov-99 FUJISAWA PHARMACEUTICAL CO LTD FK8453 DRUG SUBSTANCE AS MFG IN HYOGO AND OSAKA JAPAN 14538 09-Nov-99 SICOR DE MEXICO SA DE CV AMCINONIDE AS MFG IN LERMA MEXICO 14539 18-Nov-99 "UQUIFA ITALIA, S.P.A." CLINDAMYCIN HYDROCHLORIDE USP AS MFG IN MILAN ITALY 14540 18-Nov-99 DIOSYNTH BV TESTOSTERONE UNDECANOATE AS MFG...
21123_Ultracet.htm
Food and Drug Administration Center for Drug Evaluation and Research Approval Package Search Ultracet (325 mg Acetaminophen/37.5 mg Tramadol Hydrochloride) Tablets Company:--R Johnson Pharmaceutical Research Institute Application No.:--21-123 Approval Date:-8/15/2001 - Approval Letter(s) - Printed Labeling - Medical Review(s) - Part 1 - Part 2 - Part 3 -...
author: Paul Stauffer
CDER Template - Replace Title Here
Food and Drug Administration Center for Drug Evaluation and Research Drug Information Search First-Time Generics - June 2002 - Generic Drug Name Generic Manufacturer Brand Name Approval Date- 1- AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION, U 200 MG/28.5 MG (BASE)/5 ML, AND 400 MG/57 MG (BASE)/5 ML GENEVA PHARMACEUTICALS, INC AUGMENTIN 200 MG/5 ML AND AUGMENTIN...
author: USERNAME
ANDA Approvals June 2002
6/11/02 8 75-856 MIDAZOLAM HYDROCHLORIDE INJECTION (PRESERVATIVE-FREE) 1 MG (BASE)/ML AND 5 MG (BASE)/ML PACKAGED IN CARPUJECT SYRINGE ABBOTT LABORATORIES 6/13/02 9 40-439 AMPHETAMINE AND DEXTROAMPHETAMINE (MIXED SALTS) 10 MG (TOTAL), 20 MG (TOTAL), AND 30 MG (TOTAL) EON LABS, INC 6/14/02 10 40-444 AMPHETAMINE AND DEXTROAMPHETAMINE (MIXED SALTS) 5 MG (TOTAL), 10 MG (TOTAL),...
author: OGD
CDER Template - Replace Title Here
7/1/02 9 75-982 TRAMADOL HYDROCHLORIDE TABLETS 50 MG SIDMAK LABORATORIES, INC 7/1/02 22 75-895 SEVOFLURANE LIQUID FOR INHALATION 100 % BAXTER HEALTHCARE CORPORATION 7/2/02 23 75-849 OXAPROZIN TABLETS 600 MG TEVA PHARMACEUTICALS USA 7/3/02 24 75-963 TRAMADOL HYDROCHLORIDE TABLETS 50 MG ABLE LABORATORIES, INC 7/3/02 25 76-284 TIZANIDINE HYDROCHLORIDE ...
author: USERNAME
ANDA Drug Approvals - November 2002
-U.S 11/4/02 3 65-109 AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS, USP 500 MG/125 MG (BASE) RANBAXY LABORATORIES LIMITED 11/4/02 4 40-473 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 10 MG/500 MG ABLE LABORATORIES, INC 11/6/02 6 76-201 DICLOFENAC SODIUM EXTENDED-RELEASE TABLETS 100 MG DEXCEL LTD 11/8/02 9 75-785 OMEPRAZOLE DELAYED-RELEASE CAPSULES 10 MG, AND 20 MG...
author: OGD
Efficacy Supplements Approved in Calendar Year 1998
DILTIAZEM HYDROCHLORIDE BIOVAIL LABS 20-401 30-Jan-97 30-Jan-98 SE1 12.0 Treatment of chronic stable angina GEMCITABINE HYDROCHLORIDE LILLY 20-509 29-Aug-97 25-Aug-98 SE1 11.9 In combination with cisplatin for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB) or metastatic (Stage IV) non-small cell lung cancer IRINOTECAN ...
author: Brenda Harmon
Prescription and Over-the-Counter Drug Product List: 3/2003
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL FIORICET W/ CODEINE -D- AB + NOVARTIS 325MG;50MG;40MG;30MG N20232 001 JUL 30, 1992 MAR CAHN -A- AB + WATSON PHARMS 325MG;50MG;40MG;30MG N20232 001 JUL 30, 1992 MAR CAHN ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL CODRIX -A- + ANDRX PHARMS 500MG;30MG N40441 001...
author: AUTHOR
http://www.csl.com.au/pageManager.asp?pageID=2&countryid=0&departmentID=9&categoryid=18&productID=32
CSL Limited ABN 99 051 588 348, 45 Poplar Road Parkville 3052 VIC Australia Home / Pharmaceutical / Analgesia / Tramal - Analgesia Tramal Antibiotics Austrapen Benpen Flopen Fucidin LPV Moxacin Dermatology Advantan Daivonex Emergency Care EpiPen Adrenaline EpiPen Jr Adrenaline Minijet Adrenaline Minijet Atropine Sulfate Minijet Calcium Chloride Minijet Frusemide Minijet Glucose...
http://www.csl.com.au/pageManager.asp?pageID=2&countryid=0&departmentID=9&categoryid=18&ProductID=32
CSL Limited ABN 99 051 588 348, 45 Poplar Road Parkville 3052 VIC Australia Home / Pharmaceutical / Analgesia / Tramal - Analgesia Tramal Antibiotics Austrapen Benpen Flopen Fucidin LPV Moxacin Dermatology Advantan Daivonex Emergency Care EpiPen Adrenaline EpiPen Jr Adrenaline Minijet Adrenaline Minijet Atropine Sulfate Minijet Calcium Chloride Minijet Frusemide Minijet Glucose...
FDA Drug Approvals List August 2001
JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE Active Ingredient(s): COPPER OTC/RX Status: RX Application #:018612 Labeling Supplement#: 026 To Original New Drug Application Approval Date: 24-AUG-01 Trade Name: NICORETTE Dosage Form: GUM, CHEWING Applicant: SMITHKLINE BEECHAM CONSUMER HEALTHCARE LP Active Ingredient(s): NICOTINE POLACRILEX OTC/RX Status: RX Application #: 014879 Labeling...
FDA Drug Approvals List July 2002
- Drug Approvals for July 2002 Definitions and Notes Original New Drug Applications Original New Drug Application # 021409 Approval Date: 26-JUL-02 Trade Name: SINGULAIR Chemical Type: 3 Therapeutic Potential: S Dosage Form: GRANULE Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC Active Ingredient(s): MONTELUKAST SODIUM OTC/RX Status: RX Indication of Use: PROPHYLAXIS/CHRONIC...
FDA Drug Approvals List June 2002
- Drug Approvals for June 2002 Definitions and Notes Original New Drug Applications Original Application # 021316 Approval Date: 26-JUN-02 Trade Name: ALTOCOR Chemical Type: 3 Therapeutic Potential: S Dosage Form: TABLET Applicant: AURA LABORATORIES INC Active Ingredient(s): LOVASTATIN OTC/RX Status: RX INDICATION OF USE: For lowering total cholesterol and LDL-C to target levels as...
FDA Drug Approvals List January 2002
Active Ingredient(s):LISINOPRIL OTC/RX Status: RX Original Abbreviated Application #: 076119 Tentative Approval Date: 15-JAN-02 Trade Name: MIRTAZAPINE Dosage Form: TABLET Applicant: TEVA PHARMACEUTICALS USA INC Active Ingredient(s): MIRTAZAPINE OTC/RX Status: RX Original Abbreviated Application #: 075977 Tentative Approval Date: 15-JAN-02 Trade Name: TRAMADOL HYDROCHLORIDE ...
Prescription and OTC Drug Product List 8/2001
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST PRESCRIPTION DRUG PRODUCT LIST - 21ST EDITION ADDITIONS/DELETIONS FOR RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 8 - AUG 2001 ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL PHRENILIN WITH CAFFEINE AND CODEINE -A- AB AMARIN PHARMS 325MG;50MG;40MG;30MG N74911 001 AUG 22, 2001 AUG NEWA ACETAMINOPHEN;...
Prescription and OTC Drug Product List 11/2002
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -A- AA ABLE 325MG;5MG N40478 001 NOV 08, 2002 NOV NEWA -A- AA 500MG;10MG N40473 001 NOV 06, 2002 NOV NEWA -A- AA 500MG;5MG N40477 001 NOV 06, 2002 NOV NEWA AMCINONIDE LOTION; TOPICAL -A- AMCINONIDE -A- AB ALTANA 0.1% N76329 001 NOV 06, 2002 NOV NEWA CYCLOCORT -D- + FUJISAWA...
Prescription and OTC Drug Product List 6/2002
-A- + GD SEARLE LLC EQ 500MG BASE/VIAL N18353 001 JUL CAHN -D- + SCS EQ 500MG BASE/VIAL N18353 001 JUL CAHN MIDAZOLAM HYDROCHLORIDE INJECTABLE; INJECTION MIDAZOLAM HCL -A- AP ABBOTT EQ 1MG BASE/ML N75857 001 JUL 22, 2002 JUL NEWA -A- AP EQ 5MG BASE/ML N75857 002 JUL 22, 2002 JUL NEWA MIDODRINE HYDROCHLORIDE TABLET; ORAL PROAMATINE -A- + SHIRE LABS 5MG N19815 002 SEP 06,...
Prescription and OTC Drug Product List 6/2002
-D- + WYETH AYERST 20,000 UNITS/VIAL N17055 003 JUN DISC -A- @ 20,000 UNITS/VIAL N17055 003 JUN DISC CHORIONIC GONADOTROPIN -D- + STERIS 2,000 UNITS/VIAL N17016 011 FEB 16, 1990 JUN DISC -A- @ 2,000 UNITS/VIAL N17016 011 FEB 16, 1990 JUN DISC GRANISETRON HYDROCHLORID E SOLUTION; ORAL KYTRIL -D- + ROCHE EQ 2MG BASE/10ML N21238 001 JUN 27, 2001 JUN DISC -A- @ EQ 2MG BASE/10ML N21238...
Prescription and OTC Drug Product List 2/2002
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST AMOXICILLIN; CLAVULANATE POTASSIUM FOR SUSPENSION; ORAL AUGMENTIN '400' -D- + GLAXOSMITHKLINE 400MG/5ML;EQ 57MG BASE/5ML N50725 002 MAY 31, 1996 FEB CRLD -A- 400MG/5ML;EQ 57MG BASE/5ML N50725 002 MAY 31, 1996 FEB CRLD AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET; ORAL ...