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 400, ERYTHROMYCIN ETHYLSUCCINATE E.E.S., ERYTHROMYCIN ETHYLSUCCINATE EC-NAPROSYN, NAPROXEN ECONAZOLE NITRATE, ECONAZOLE NITRATE ECONOCHLOR, CHLORAMPHENICOL ECONOPRED PLUS, PREDNISOLONE ACETATE ECONOPRED, PREDNISOLONE ACETATE EDECRIN, ETHACRYNATE SODIUM EDECRIN, ETHACRYNIC ACID EDETATE DISODIUM, EDETATE DISODIUM EDEX, ALPROSTADIL EDROPHONIUM CHLORIDE PRESERVATIVE FREE, EDROPHONIUM...
EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2003 VENLAFAXINE HYDROCHLORIDE WYETH AYERST 20-699 SE1 022 12-Sep-01 11-Feb-03 17.0 Provides for the use of Effexor XR (venlafaxine hydrochloride) Extended-release Capsules for the treatment of social anxiety disorder as a new indication
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.fda.gov/cder/ogd/rld/RLD_LABELING_APPROVED_DEC_1998.HTML 9-Dec-1998 TRIDIL INJECTION Nitroglycerine Injection 18-537 S-015 Faulding 9-Dec-1998 EFFEXOR Venlafaxine Hydrochloride 20-151 S-009 Wyeth Ayerst 9-Dec-1998 NITROGLYCERIN IN DEXTROSE Nitroglycerin 19-970 S-009 Baxter Hlthcare 9-Dec-1998 REBETOL Interferon Alfa-2b, Recombinant Capsules 20-903 S-002 Schering Plough Res 9-Dec-1998 BRETHINE INJECTION Terbutaline Sulfate...
FDA Drug Approvals List May 2001 Pylori eradication to reduce the risk of duodenal ulcer recurrence, maintenance of healed duodenal ulcers, short-term treatment of active benign gastric ulcer, short-term treatment of symptomatic gastroesophageal reflux disease (GERD), short-term treatment of erosive esophagitis, maintenance of healing of erosive esophagitis, and pathological hypersecretory conditions including...
Prescription and OTC Drug Product List 5/2002 2 -D- + ROBINS AH 325MG;15MG N84444 001 MAY DISC -A- @ 325MG;15MG N84444 001 MAY DISC SOLUTION; ORAL ACETAMINOPHEN AND CODEINE PHOSPHATE -D- AA ALPHARMA 120MG/5ML;12MG/5ML N85861 001 MAY CRLD -A- AA + 120MG/5ML;12MG/5ML N85861 001 MAY CRLD TYLENOL W/ CODEINE -D- AA + JOHNSON RW 120MG/5ML;12MG/5ML N85057 001 MAY DISC -A- @ 120MG/5ML;12MG/5ML N85057 001 MAY DISC TABLET; ORAL...
Efficacy Supplements Approved in Calendar Year 2001 (SE1-SE7 AND SE8S) VENLAFAXINE HCL WYETH AYERST LABS 20-151 19-May-00 2-May-01 SE1 017 N 11.4 Provides for the use of Effexor Tablets for the prevention of recurrence of depression and for the prevention of relapse of depressionVENLAFAXINE HCL WYETH AYERST LABS 20-151 22-May-00 2-May-01 SE1 018 N 11.3 Provides for the use of Effexor Tablets for the prevention of recurrence...
author: Darlene Norris
Prescription and OTC Drug Product List October 1997 Prescription and Over-the-Counter Drug Product List - 17th Edition Cumulative Supplement Number 10: Jan '97 - Oct '97 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE CAPSULE; ORAL OXYCODONE AND ACETAMINOPHEN...
Drug Approvals for May 1997 orbiculare) Application #:020297Efficacy Supplement#:001 Type: SE1 to Original New Drug Application Approval Date: 29-MAY-97 Trade Name: COREG Dosage Form: TABLET Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS Active Ingredient(s): CARVEDILOL OTC/RX Status: RX Efficacy Claim: For the new indication of congestive heart failure and a new dosage strength of 3.125 mg Application #...
FDA Drug Approvals List- March 1999 Drug Approvals for March 1999 Definitions and Notes March 1999 Original New Drug Applications Original Application #: 020966 Approval Date: 30-MAR-99 Trade Name: SPORANOX Chemical Type: 3 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: JANSSEN RESEARCH FDN DIV JOHNSON AND JOHNSON Active Ingredient(s): ITRACONAZOLE OTC/RX Status: RX Indication(s): For the treatment of...
FDA Drug Approvals List June 2000 Active Ingredient(s): MIDAZOLAM HYDROCHLORIDE OTC/RX Status: RX Original Abbreviated Application # 075448 Approval Date: 19-JUN-00 Trade Name: ISOSORBIDE MONONITRATE Dosage Form: TABLET, EXTENDED RELEASE Applicant: ZENITH GOLDLINE PHARMACEUTICALS Active Ingredient(s): ISOSORBIDE MONONITRATE OTC/RX Status: RX Original Abbreviated Application # 075549 Approval Date: 13-JUN-00...
FDA Drug Approvals List- December 1998 Drug Approvals for December 1998 Definitions and Notes December 1998 Original New Drug Applications Original Application #: 020998 Approval Date: 31-DEC-98 Trade Name: CELEBREX Chemical Type: 1 Therapeutic Potential: P Dosage Form: CAPSULE Applicant: GD SEARLE AND CO Active Ingredient(s): CELECOXIB OTC/RX Status: RX Indication(s):For the signs and symptoms of osteoarthritis and...
DDPA June 1996 74-515 TIMOLOL MALEATE AKRON TIMOLOL MALEATE 17-JUN-96 (SOLUTION) DECATUR, IL EQ 0.25% BASE 62525 (BETA ADRENERGIC BLOCKER) 74-516 TIMOLOL MALEATE AKRON TIMOLOL MALEATE 17-JUN-96 (SOLUTION) DECATUR, IL EQ 0.5% BASE 62525 (BETA ADRENERGIC BLOCKER) 16-096 MINTEZOL MSD THIABENDAZOLE 03-JUN-96 (TABLET, CHEWABLE) WEST POINT, PA 500MG 19486 (LABELING REVISION -- INDICATIONS AND USAGE;...
Drug Approvals for October 1997 Drug Approvals for October 1997 Definitions and Notes October 1997 Original New Drug Applications Original Application #: 020755 Approval Date: 31-OCT-97 Trade Name: CAVERJECT Chemical Type: 5 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: PHARMACIA AND UPJOHN CO Active Ingredient(s): ALPROSTADIL OTC/RX Status: RX Indication(s): Provides for an aqueous formulation for...
IFPMA Adapting Innovation int 2 3 INDEX ADAPTIVE INNOVATION, INTELLECTUAL PROPERTY AND THE PUBLIC INTEREST: HOW PATENT EXTENSION LEADS TO MORE, BETTER AND SAFER MEDICINES INNOVATION: IT'S IN THE EYE OF THE BEHOLDER 10 PUTTING THEORY INTO PRACTICE: FIVE CASE STUDIES 11 Case Study 1: Zithromax SR [azithromycin] 12 Case Study 2: Neurontin [gabapentin] 14 Case Study 3: Procardia XL 16 Case Study 4: Agenerase 17 Case...
author: Jupiter
IFPMA Adapting Innovation int 2 page 19
author: Jupiter
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...
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...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs. Salmeterol to Zolpidem Trade Names of Some Commonly Used Drugs GENERIC AND TRADE NAMES OF COMMONLY USED DRUGS Salmeterol to Zolpidem Generic Trade Name Salmeterol SEREVENT Salsalate DISALCID, SALFLEX Saquinavir FORTOVASE Sargramostim LEUKINE Secobarbital SECONAL Selegiline ELDEPRYL Selenium SELSUN Sertraline ZOLOFT Sibutramine MERIDIA Sildenafil VIAGRA Silver sulfadiazine SILVADENE Simethicone MYLICON...
Depression: Depression and Mania: 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...
Wyeth: News & Announcements Discontinuation of Treatment A-Discontinuation of EFEXOR may cause withdrawal symptoms in some patients.A- It has always been recommended that discontinuation of therapy be gradual, as appropriately tapering the dose minimizes the risk of patients developing symptoms.A- Patients should not discontinue therapy without consulting with their prescribing physician.A- About Venlafaxine ...
Wyeth: News & Announcements Food and Drug Administration (FDA) has approved new labeling for the prevention of major depressive disorder relapse for two versions of the company's antidepressant, venlafaxine HCl, marketed as Effexor ® tablets and Effexor ® XR extended-release capsules by Wyeth-Ayerst Laboratories, the pharmaceutical division of AHP.Venlafaxine Venlafaxine ...
