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...
http://www.fda.gov/cder/orange/appendix_a.txt 4, ACETAMINOPHEN PHENAPHEN-650 W/ CODEINE, ACETAMINOPHEN PHENAZINE, PHENDIMETRAZINE TARTRATE PHENAZINE-35, PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE PHENERGAN FORTIS, PROMETHAZINE HYDROCHLORIDE PHENERGAN PLAIN, PROMETHAZINE HYDROCHLORIDE PHENERGAN VC W/ CODEINE, CODEINE PHOSPHATE PHENERGAN VC, PHENYLEPHRINE HYDROCHLORIDE PHENERGAN W...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt LOUIS, MISSOURI" 12443 28-Mar-97 SCHERING PLOUGH PRODUCTS INC "STERILE WATER FOR INJECTION, MANUFACTURED IN MANATI, PUERTO RICO" 12444 26-Mar-97 ORION CORP FERMION "ENTACAPONE, MANUFACTURED IN HANKO AND ESPOO, FINLAND" 12445 18-Mar-97 NAPP TECHNOLOGIES INC "NABUMETONE, MANUFACTURED IN COVENTRY, RHODE ISLAND" 12449 03-Apr-97 PHARM ECO LABORATORIES INC "2-AMINO-5-PHENYL-4(5H)-OXAZOLONE...
FDA Drug Approvals List June 2001 PERRIGO COMPANY Active Ingredient(s): MONOXIDIL OTC/RX Status: RX Original Abbreviated Application # 075750 Approval Date: 8-JUN-01 Trade Name: DOXAZOSIN MESYLATE Dosage Form: TABLET Applicant: SIDMAK LABORATORIES, INC Active Ingredient(s): DOXAZOSIN MESYLATE OTC/RX Status: RX Original Abbreviated Application # 075502 Approval Date: 05-JUN-01 Trade Name: CLOTRIMAZOLE AND...
FDA Drug Approvals List April 2001 - Drug Approvals for April 2001 Definitions and Notes Original New Drug Applications Original Application #: 020949 Approval Date: 30-APR-01 Trade Name: ACCUNEB Chemical Type: 5 Therapeutic Potential: S Dosage Form: SOLUTION Applicant: DEY LABORATORIES INC Active Ingredient(s): ALBUTEROL SULFATE OTC/RX Status: RX Indication(s): For the treatment of asthma-related bronchospasm in...
FDA Drug Approvals List July 2002 45 Dosage Form: INJECTABLE Applicant: XCEL PHARMACEUTICALS Active Ingredient(s): DIHYDROERGOTAMINE MESYLATE OTC/RX Status: RX Application #: 020449 Labeling Supplement #: 019 To Original New Drug Application Approval Date: 30-JUL-02 Trade Name: TAXOTERE Dosage Form: INJECTABLE Applicant: AVENTIS PHARMACEUTICALS INC Active Ingredient(s): DOCETAXEL OTC/RX Status: RX Application #:...
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...
FDA Drug Approvals List November 1999 Approvable Original New Drug Applications Original Application #: 020125 Approvable Date: 30-NOV-99 Trade Name: ACCURETIC Dosage Form: TABLET Applicant: PARKE DAVIS PHARMACEUTICAL RESEARCH DIV WARNER LAMBERT CO Active Ingredient(s): QUINAPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE OTC/RX Status: RX Original Abbreviated Application #: 075366 Tentative Approval Date: 02...
FDA DRUG AND DEVICE PRODUCT APPROVALS 74-776 TIMOLOL MALEATE BAUSCH AND LOMB TIMOLOL MALEATE 26-JUL-96 (SOLUTION/DROPS) TAMPA, FL 0.5% 33637 (BETA ADRENERGIC BLOCKER) 74-778 TIMOLOL MALEATE BAUSCH AND LOMB TIMOLOL MALEATE 26-JUL-96 (SOLUTION/DROPS) TAMPA, FL 0.25% 33637 (BETA ADRENERGIC BLOCKER) 74-465 TIMOLOL MALEATE ADV REMEDIES TIMOLOL MALEATE 30-JUL-96 (SOLUTION/DROPS) SOMERSET, NJ 0.25% 08873 (BETA ADRENERGIC...
DDPA April 1996 ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 20-262 TAXOL BRISTOL MYERS SQUIBB PACLITAXEL 01-APR-96 (INJECTABLE) WALLINGFORD, CT 6MG/ML 06492 (LABELING REVISION -- BOXED WARNING; DESCRIPTION; WARNINGS; PRECAUTIONS; ADVERSE REACTIONS; DOSAGE AND ADMINISTRATION; HOW SUPPLIED) 18-602 CARDIZEM HOECHST MARION RSSL DILTIAZEM HYDROCHLORIDE 02-APR-96 (TABLET) KANSAS CITY, MO 30MG 64134...
July Drug Approvals Drug Approvals for July 1996 Definitions and Notes Original New Drug Application Original Application #: 020538 Approval Date: 31-JUL-96 Trade Name: ESTRADIOL Chemical Type: Already marketed drug product but a new manufacturer Therapeutic Potential: Standard review drug Dosage Form: FILM, EXTENDED RELEASE Applicant: MENOREST MANFACTURING INC Active Ingredient(s): ESTRADIOL OTC/RX...
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...
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...
Heart Failure: Merck Manual Home Edition Section Heart and Blood Vessel Disorders Subject Heart Failure Heart Failure Heart failure is a disorder in which the heart pumps blood inadequately, leading to reduced blood flow, back-up (congestion) of blood in the veins and lungs, and other changes that may further weaken the heart.
High Blood Pressure: Merck Manual Home Edition With reserpine, depression, nasal congestion, lethargy, and bleeding of a peptic ulcer Centrally acting alpha-agonists - Clonidine Guanabenz Guanfacine Methyldopa Drowsiness, dry mouth, fatigue, an abnormally slow heart rate, rebound high blood pressure when the drug is withdrawn (except with methyldopa ), and sexual dysfunction With methyldopa , depression, low blood pressure when...
Heart Failure: 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...
High Blood Pressure: Merck Manual Home Edition With reserpine, depression, nasal congestion, lethargy, and bleeding of a peptic ulcer Centrally acting alpha-agonists - Clonidine Guanabenz Guanfacine Methyldopa Drowsiness, dry mouth, fatigue, an abnormally slow heart rate, rebound high blood pressure when the drug is withdrawn (except with methyldopa Some Trade Names ALDOMET ), and sexual dysfunction With methyldopa Some Trade...
Maximum Recommended Therapeutic Dose (MRTD) Database Maximum Recommended Therapeutic Dose (MRTD) Database (1,235 pharmaceuticals) A -- B- - C -- D -- E -- F-G -- H-K -- L -- M -- N -- O -- P -- Q-R -- S -- T -- U-Z MRTD--- (mg/kg--- bw/day) -- Generic Chemical Name Chemical Structure (SMILES Code) 3.00000-- Acemetacin C1=C(OC)C=C3C(=C1)N(C(=O)C2=CC=C(Cl)C=C2)C(C)=C3CC(=O)OCC(O)=O 0.20000-- Acenocoumarol C1=CC=C3C(=C1)OC(=O)C(C(CC(C)=O...
LIST OF APPROVED DRUGS FOR WHICH ADDITIONAL PEDIATRIC INFORMATION DOCKET NOHydrochlorothiazide Treatment of...
http://www.MTRA.com/home/bioanalytical_listing.pdf Bioanalytical Assay List AAI International, Inc. 2320 Scientific Park Drive, Wilmington, NC 28405 USA Phone: 1.800.575.4AAI (4224) Fax: 1.910.815.2300 Bioanalytical Laboratories 12400 Shawnee Mission Parkway, Shawnee Kansas 66216 (P: 913.248.3000 / F: 913.248.3106) Wegenerstrasse 13, ...
may20lst.PDF 98N- 0056 May 20, 1998 Page 6 Drug Name Potential pediatric use limited to approved indications Age Group In Which More Information Needed birth to 1 mos 1 mos to 2 yrs 2 to 12 years 12 to 16 years Milrinone Treatment of heart failure Yes Yes Yes Yes Minoxidil Hypertension Yes Yes Yes Yes Moexipril Hypertension Yes Yes Yes Yes Moexipril/ Hydrochlorothiazide Hypertension Yes Yes...
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Teva Pharmaceutical Industries - News and PR - - Search Tevapharm: - - Press Releases 2004 - 2005: Teva Announces Approval Of Methylprednisolone Acetate Injectable Suspension Jerusalem, Israel, February 24, 2005 Teva and Lundbeck Announce European Approval for AZILECT® (rasagiline) 1mg for Parkinson's Disease Jerusalem, Israel and Copenhagen, Denmark, February 22, 2005 Teva Announces Settlement Of Lamictal® Litigation...
Teva Pharmaceutical Industries - News and PR - - Search Tevapharm: - - Press Release Teva Announces Final Approval for Quinapril Hydrochloride Tablets Jerusalem, Israel, June 2, 2003 - Teva Pharmaceutical Industries Ltd.Quinapril HCl Tablets, 5 mg, 10 mg, 20 mg and 40 mg.
Teva Pharmaceutical Industries - News and PR Jerusalem, Israel, and Hawthorne, NY, September 23, 2003, September 23, 2003 Teva Announces Approval of Nefazodone HCl Tablets 50 mg, 100 mg, 150 mg, 200 mg and 250 mg Jerusalem, Israel, September 16, 2003 Teva Announces NDA Submission of Rasagiline as a Treatment for Parkinson's Disease Jerusalem, Israel, September 8, 2003 Teva Announces Approval of Ofloxacin Tablets 200 mg, 300 mg,...
