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 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,...
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...
author: USERNAME
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 ...
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 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...
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...
RLD_LABELING_ APPROVED_AUG_1999 Product Name Drug Name NDA No Supp.No Firm Date LARIAM Mefloquine HCl Tablets 19-591 S-012 Roche 02-Aug-1999 PROSCAR Finasteride Tablets 20-180 S-018 Merck 02-Aug-1999 CEFOTAN Cefatetan Disodium 50-588 S-026 Zeneca 05-Aug-1999 MARINOL Dronabinol Capsules 18-651 S-011 Unimed 05-Aug-1999 ZOCOR Simvastatin Tablets 19-766 S-032 Merck 05-Aug-1999 GLUCOTROL Glipizide Tablets 17...
Dec approvalletter.PDF page 5
author: andersonrob
Dec approvalletter.PDF page 2
author: andersonrob
http://www.fda.gov/cder/foi/label/2003/19591slr014,017_Lariam_lbl.pdf doc 1 LARIAM a a brand of mefloquine hydrochloride TABLETS DESCRIPTION Lariam (mefloquine hydrochloride) is an antimalarial agent available as 250- mg tablets of mefloquine hydrochloride (equivalent to 228.0 mg of the free base) for oral administrationLariam, are at high risk of relapse because Lariam does not eliminate...
http://www.fda.gov/cder/foi/label/2003/19591slr014,017_Lariam_lbl.pdf page 8
http://www.fda.gov/cder/foi/label/2003/19591slr014,017_Lariam_lbl.pdf page 4
http://www.fda.gov/cder/foi/label/2003/19591slr014,017_Lariam_lbl.pdf page 1
http://www.adis.com/files/newsletters/AIT/Aicov47.pdf 9 Antiretrovirals: illegal trading diverts low- cost drugs back to Europe 4 Antiviral therapy worth it in influenza infections 13 Artemether/ lumefantrine interaction with quinine 10 Atovaquone + proguanil: neuropsychiatric AEs 14 Biofilms aid antibacterial resistance in CF 2 Chloroquine resistance conferred by pfcrt mutations 6 Chlorproguanil/ dapsone regimen for malaria 11 Decoding...
http://www.fda.gov/cder/foi/label/2002/19591s20lbl.pdf Lariam should not be prescribed for prophylaxis HLR 07/ 10/ 02 LARIAM O O (mefloquine hydrochloride) 3 in patients with active depression, a recent history of depression, generalized anxiety disorder, psychosis, or schizophrenia or other major psychiatric disorders, or with a history of convulsions
http://www.fda.gov/cder/foi/label/2002/19591s20lbl.pdf page 6
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http://www.fda.gov/cder/foi/label/2002/19591s20lbl.pdf page 1
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...
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...
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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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
author: USERNAME
