Drug Approvals - A
ANDA 75-819 9/11/02 Amantadine Hydrochloride Syrup USP, 50 mg and 5 mL Morton Grove Pharmaceuticals ANDA 75-060 12/24/98 12/24/98 - - Amantadine Hydrochloride Tablets, 100 mg, Rx Upsher-Smith Laboratories, Inc ANDA 76-096 11/19/02 Amerge (Naratriptan) Tablets, GlaxoSmithKline NDA 20-763/S5 10/27/03 11/5/03- - - Amerge (Naratriptan hydrochloride)...
http://www.fda.gov/cder/orange/appendix_a.txt
3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE #3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE, ACETAMINOPHEN ACETAMINOPHEN, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN AND CAFFEINE, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN, BUTALBITAL AND CAFFEINE, ACETAMINOPHEN ACETAMINOPHEN,...
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 August 2000
Original Application #: 021197 Approval Date: 11-AUG-00 Trade Name: CETROTIDE Chemical Type: 1 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: ASTA MEDICA INC Active Ingredient(s): CETRORELIX OTC/RX Status: RX Indication(s): For the prevention of premature LH surges in women undergoing controlled ovarian stimulation Original Application #: 021128 Approval Date: 01-AUG-00...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, ABBOKINASE to BUTAZOLIDIN
Trade Names of Some Commonly Used Drugs TRADE AND GENERIC NAMES OF COMMONLY USED DRUGS ABBOKINASE to BUTAZOLIDIN Trade Name Generic ABBOKINASE Urokinase ACCOLATE Zafirlukast ACCUPRIL Quinapril ACCUTANE Isotretinoin ACHROM YCIN V Tetracycline ACTHAR Corticotropin (ACTH) ACTIFED *Triprolidine ADALAT Nifedipine ADENOCARD Adenosine ADRIAMYCIN Doxorubicin ADVIL Ibuprofen AFRIN...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, Nabumetone to Oxytocin
Trade Names of Some Commonly Used Drugs GENERIC AND TRADE NAMES OF COMMONLY USED DRUGS Nabumetone to Oxytocin Generic Trade Name Nabumetone RELAFEN Nadolol CORGARD Nafcillin UNIPEN Na lbuphine NUBAIN Nalidixic acid NegGRAM Naloxone NARCAN Naltrexone REVIA Nandrolone DURABOLIN Naproxen ALEVE, ANAPROX, NAPROSYN Naratriptan AMERGE Nedocromil TILADE Nefazodone SERZONE...
Triptans (serotonin receptor agonists) for migraine headaches - [Medication] - Quest Diagnostics Patient Health Library
Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About - References Triptans (serotonin receptor agonists) for migraine headaches - [Medication] - Quest Diagnostics Patient Health Library Triptans (serotonin receptor agonists) for migraine headaches - [Medication] - Quest Diagnostics Patient Health Library Brain and nerves,...
BioPortfolio Limited
Many companies could benefit from assessing their existing delivery technologies in other therapeutic areas, such as diabetes (needle-free injections, inhaled insulins), HRT (sustained-release patch technology) and others 10 CHAPTER 2 INTRODUCTION AND SCOPE 21 Disease overview 21 Etiology 21 Diagnosis and classification of migraine 22 Migraine diagnosis 22 Patient history and diaries...
http://www.merck.com/product/usa/pi_circulars/m/maxalt/maxalt_ppi.pdf
9601304 1 Patient Information about MAXALT ® (max- awlt) and MAXALT- MLT ® for Migraine Generic name: rizatriptan benzoate Please read this information before you start taking MAXALT *. COPYRIGHT MERCK & CO., Inc., 1998 All rights reserved MAXALT ® (Rizatriptan Benzoate) Tablets MAXALT- MLT ® (Rizatriptan Benzoate) Orally Disintegrating Tablets 9601304 2 If you...
http://www.merck.com/product/usa/pi_circulars/m/maxalt/maxalt_ppi.pdf page 3
http://www.merck.com/product/usa/pi_circulars/m/maxalt/maxalt_ppi.pdf page 2
27993Proforma
1 Fact Sheet Update Promoted Products Frova TM (frovatriptan succinate) 2.5 mg Tablets Product (generic name) FROVA TM (frovatriptan succinate) 2.5 mg Tablets Indication FROVA TM is indicated for the acute treatment of migraine attacks with and without aura in adults Although no systematic monitoring of ophthalmologic function was undertaken in clinical trials and no specific...
author: Macuser
27993Proforma page 6
author: Macuser
duplicates:http://www.elan.com/Images/Frova_PI_200204_tcm3-4345.pdf
ECL EMD M1 068X frova PI
FROVA TM (frovatriptan succinate) Tablets DESCRIPTION FROVA* (frovatriptan succinate) tablets contain frovatriptan succinate, a selective 5- hydroxy- tryptamine1 (5- HT1B/ 1D) receptor subtype agonist, as the active ingredient The AUC in subjects with mild (Child- Pugh 5- 6) to moderate (Child- Pugh 7- 9) hepatic impairment is about twice as high as the AUC in young, healthy...
author: Lisa Babb
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, ABBOKINASE to BUTAZOLIDIN
Trade Names of Some Commonly Used Drugs TRADE AND GENERIC NAMES OF COMMONLY USED DRUGS ABBOKINASE to BUTAZOLIDIN Trade Name Generic ABBOKINASE Urokinase ACCOLATE Zafirlukast ACCUPRIL Quinapril ACCUTANE Isotretinoin ACHROMYCIN V Tetracycline ACTHAR Corticotropin (ACTH) ACTIFED *Triprolidine ADALAT Nifedipine ADENOCARD Adenosine ADRIAMYCIN Doxorubicin ADVIL Ibuprofen AFRIN...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, Nabumetone to Oxytocin
Trade Names of Some Commonly Used Drugs GENERIC AND TRADE NAMES OF COMMONLY USED DRUGS Nabumetone to Oxytocin Generic Trade Name Nabumetone RELAFEN Nadolol CORGARD Nafcillin UNIPEN Nalbuphine NUBAIN Nalidixic acid NegGRAM Naloxone NARCAN Naltrexone REVIA Nandrolone DURABOLIN Naproxen ALEVE, ANAPROX, NAPROSYN Naratriptan AMERGE Nedocromil TILADE Nefazodone SERZONE...
C:\My Documents\AMERGE.NDA\SLR005_AP_Let.doc page 1
author: Lana Chen
20763_Amerge
Food and Drug Administration Center for Drug Evaluation and Research Title Search Amerge (Naratriptan) Tabelts Company:--GlaxoWellcome Inc Application No.:--20-763 Approval Date:-2/10/1998 Approval Letter(s) - Medical Review(s)- Part 1 - Part 2 - Part 3 - Part 4 - Chemistry Review(s) - Environmental Assessment - Pharmacology Review(s) - Statistical Review(s)-...
author: USERNAME
AXERT PI
Prescribing Information DESCRIPTION AXERT Tablets contain almotriptan malate, a selective 5- hydroxytryptamine1B/ 1D (5- HT1B/ 1D ) receptor agonist Patients enrolled in these studies were primarily female (86%) and Caucasian (more than 98%), with a mean age of 41 years (range of 18 to 72) Cardiac Events and Fatalities Associated with 5- HT1 Agonists: Serious adverse cardiac...
author: Donna
Zomig NS AP Ltr Sep 30.doc
Rev 09/ 03 SIC Rx only ZOMIG (zolmitriptan) Nasal Spray For Nasal Use Only DESCRIPTION ZOMIG ® (zolmitriptan) Nasal Spray contains zolmitriptan, which is a selective 5- hydroxytryptamine 1B/ 1D (5- HT 1B/ 1D ) receptor agonist ZOMIG should not be given to patients with cerebrovascular syndromes including (but not limited to) stroke of any type as well as transient ischemic...
author: CHENLA
Zomig NS AP Ltr Sep 30.doc page 25
author: CHENLA
MAXALT Product Monograph page 14
author: Merck Frosst Canada & Co
subject: 729-a,9,01
http://www.merck.com/product/usa/pi_circulars/m/maxalt/maxalt_ppi.pdf
9122203 1 Patient Information about MAXALT ® (max- awlt) and MAXALT- MLT ® for Migraine Generic name: rizatriptan benzoate Please read this information before you start taking MAXALT * If you are receiving propranolol, you should use the 5- mg dose of MAXALT or MAXALT- MLT, up to a maximum of 3 doses (15 mg total) in a 24- hour period MAXALT should not be used within...
http://www.merck.com/product/usa/pi_circulars/m/maxalt/maxalt_ppi.pdf page 3
duplicates:http://www.fda.gov/cder/foi/label/2002/20865slr009lbl.pdf
http://www.merck.com/product/usa/pi_circulars/m/maxalt/maxalt_ppi.pdf page 2