Drug Approvals - M ANDA 40-311 12/1/99 12/28/99 - - Mefloquine Hydrochloride Tablets, 250 mg, Rx Barr Laboratories ANDA 76-392 12/29/03 Mefloquine Hydrochloride Tablets, 250 mg, Rx, Tentatively Approved Roxane ANDA 76-523 9/12/03 Mefloquine Hydrochloride Tablets, 250 mg, Rx Geneva Pharamaceuticals- ANDA 76-175 2/20/02 4/11/03 - 8/6/03 Megace (megestrol acetate) Oral...
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 ACTHAR GEL, CORTICOTROPIN H.R.-50, HYDROCHLOROTHIAZIDE HABITROL, NICOTINE (OTC) HALCION, TRIAZOLAM HALDOL SOLUTAB, HALOPERIDOL HALDOL, HALOPERIDOL HALDOL, HALOPERIDOL DECANOATE HALDOL, HALOPERIDOL LACTATE HALDRONE, PARAMETHASONE ACETATE HALFAN, HALOFANTRINE HYDROCHLORIDE HALOG, HALCINONIDE HALOG-E, HALCINONIDE HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE HALOPERIDOL INTENSOL,...
ANDA Approvals - December 2003 - FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Approvals - December 2003 - ANDA Number Generic Drug Name Applicant Approval Date 1 65-161 AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS USP (CHEWABLE) 200 MG/28.5 MG (BASE) AND 400 MG/57 MG (BASE) - RANBAXY LABORATORIES LIMITED 12/3/2003- 2 76-656 FENOLDOPAM MESYLATE INJECTION, USP 10 MG...
Prescription and Over-the-Counter Drug Product List: 4/2003 45 -D- XCEL PHARMS 1MG/ML N05929 001 APR CFTG -A- AP + 1MG/ML N05929 001 APR CFTG -A- DIHYDROEROGTAMINE MESYLATE -A- AP PADDOCK 1MG/ML N40475 001 APR 28, 2003 APR NEWA DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE; ORAL -A- TAZTIA XT -A- AB4 ANDRX PHARMS 120MG N75401 001 APR 10, 2003 APR NEWA -A- AB4 180MG N75401 002 APR 10, 2003 APR NEWA -A- AB4 240MG N75401 003 APR 10,...
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First-Time Generics - February 2001 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search First-Time Generics - February 2002 - Generic Name Brand Name Approval Date 1 KETOPROFEN TABLETS 12.5 MG TABLETS AND CAPLETS ORUDIS KT TABLETS 2/7/02 2 AMPHETAMINE AND DEXTROAMPHETAMINE (MIXED SALTS) 5 MG (TOTAL), 10 MG (TOTAL), 20 MG (TOTAL) AND 30 MG (TOTAL) ADDERAL TABLETS 2/11/02 3...
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ANDA Approvals February 2002 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - February 2002 - ANDA Number Drug Name Applicant Approval Date 1 75-810 FLUOXETINE HYDROCHLORIDE TABLETS 10 MG (BASE) BARR LABORATORIES, INC
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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 ...
http://www.fda.gov/cder/foi/label/2002/20250s7s8lbl.pdf 1 HL: L4 PRESCRIBING INFORMATION HALFAN a a brand of halofantrine hydrochloride Tablets WARNING: HALFAN HAS BEEN SHOWN TO PROLONG QTc INTERVAL AT THE RECOMMENDED THERAPEUTIC DOSEMEFLOQUINE, OR IN PATIENTS...
FDA Drug Approvals List August 1999 Approvable Original New Drug Applications Original Application #: 021037 Approvable Date: 26-AUG-99 Trade Name: MAGNEVIST Dosage Form: INJECTABLE Applicant: BERLEX LABORATORIES INC Active Ingredient(s): GADOPENTETATE DIMEGLUMINE OTC/RX Status: RX Original Application #: 020989 Approvable Date: 27-AUG-99 Trade Name: EVOXAC Dosage Form: CAPSULE Applicant: SNOWBRAND PHARMACEUTICALS INC...
Drug Approvals for August 1997 Drug Approvals for August 1997 Definitions and Notes August 1997 Original New Drug Applications Original Application #: 020808 Approval Date: 29-AUG-97 Trade Name: VISIPAQUE Chemical Type: 3 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: NYCOMED INC Active Ingredient(s): IODIXANOL OTC/RX Status: RX Indication(s): Intra-arterial - for visceral intra-arterial digital...
Malaria: Parasitic Infections: Merck Manual Home Edition Section Infections Subject Parasitic Infections Malaria Malaria is infection of red blood cells with the single-celled parasite Plasmodium, which causes fever, an enlarged spleen, and anemia.
Malaria: Parasitic Infections: 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...
THE MERCK MANUAL, Sec. 13, Ch. 161, Parasitic Infections This Publication Is Searchable The Merck Manual of Diagnosis and Therapy--- Section 13.Mefloquine is recommended for travel to areas where chloroquine-resistant P.Mefloquine causes self-limited dizziness and GI disturbances.
Index: ME: Merck Manual Home Edition in ovulation problems Problems With Ovulation: Treatment in undernutrition Undernutrition: Feeding Methods Medulloblastoma Tumors That Originate in or Near the Brain Mefloquine Malaria: Prevention and Treatment Megacolon toxic Ulcerative Colitis: Complications Ulcerative Colitis: Surgery Megestrol Human Immunodeficiency Virus Infection: Treatment Meglitinides Oral...
Medications - Quest Diagnostics Patient Health Library 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 - (0-9) - MA - ME - MI - MO - MU - MA - Macrolides for pneumonia - Magnesium sulfate for preterm labor - Magnesium sulfate for seizure prevention during pregnancy - Malarone for malaria - Malathion for lice - Mast cell stabilizers for long-term control of asthma - ME - Mebendazole for...
Mefloquine for malaria - [Medication] - Quest Diagnostics Patient Health Library Mefloquine for malaria Examples Brand Name Chemical Name Lariam mefloquine hydrochloride How It Works Mefloquine slows down or kills the parasites in blood that cause malaria.Mefloquine does not destroy the Plasmodium (P.) vivax or P.Mefloquine is usually effective against all four species of Plasmodium and in regions where the chloroquine-resistant P....
All Topics - Quest Diagnostics Patient Health Library - Clearinghouse - New York - [Support Group] - Meckel Syndrome - Meckel-Gruber Syndrome - MED - Median Cleft Face Syndrome - Mediastinoscopy - [Medical Test] - Medical Consumer Helpline - [Support Group] - Medical Decision-making - Medical Errors Prevention - Medical Escrow Society - Life-Threatening Ill Helpline - [Support Group] - Medical history and physical exam for a fast heart...
Cedra Corp. Methods List April 2004.xls CEDRA's List of GLP Validated, Pharmaceutical Bioanalytical Methods Drug Species AntiCoagulant Matrix Extraction Volume Range Abacavir* Human Plasma 0.05 mL 25 – 5000 ng/ mL Acetaminophen* Human Heparin Plasma 0.2 mL 0.25 – 25 µg/ mL Acetaminophen* Human Heparin Plasma 0.25 mL 0.15 – 15 µg/ mL Acetaminophen* 0.15 – 15 µg/ mL Propoxyphene* 1 –...
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Cedra Corp. Methods List April 2004.xls page 5
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http://www.adis.com/files/newsletters/REA/Rxcov989.pdf 5 Hyaluronan/ diclofenac: allergic contact dermatitis 9 Antidepressants: impact of side effects on adolescent QOL 3 Hydroxycarbamide: acute myeloid leukaemia [S] 11 Antineoplastics: spermatogenesis recovery may occur but is 4 Immunotherapy/ influenza virus vaccine: multiple 11 unpredictable sclerosis [ S] Citalopram exposure via breast milk: no increase in adverse 4 Influenza virus...
http://www.adis.com/files/newsletters/INP/Icov1425.pdf faecium endocarditis in infant 18 Mitoxantrone/ chlorambucil/ prednisone in MALT lymphoma 18 Lopinavir/ ritonavir: pharmacokinetics in HIV 19 Octreotide ± prednisone in advanced thymoma 17 Mefloquine not associated with increased risk of depression 21 PCK 3145 in metastatic hormone- refractory prostate cancer 6 Nevirapine reduces indinavir/ ritonavir trough concentrations...
THE MERCK MANUAL, Sec. 13, Ch. 161, Parasitic Infections This Publication Is Searchable The Merck Manual of Diagnosis and Therapy--- Section 13Mefloquine is recommended for travel to areas where chloroquine-resistant PMefloquine causes self-limited dizziness and GI disturbances
Cedra Corp. Methods List January 2004.xls page 5
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