Drug Approvals - M NDA 20-865/S-001 NDA 20-864/S-003 11/23/99 12/30/99 - - Maxaquin (lomefloxacin hydrochloride) Unimed NDA 20-013/S-08 10/24/01 - 4/17/03 - Maxidex (dexamethasone ophthalmic suspension), 0.1%, Rx Alcon Laboratories, IncHydrochloride Injection,1 mg (base)/mL & 5 mg (base)/mL, Rx Bedford Laboratories ANDA 75-247 6/23/00 10/31...
http://www.fda.gov/cder/orange/appendix_a.txt PEDIATRIC, ASCORBIC ACID M.V.I.-12 LYOPHILIZED, ASCORBIC ACID M.V.I.-12, ASCORBIC ACID MACROBID, NITROFURANTOIN MACRODANTIN, NITROFURANTOIN, MACROCRYSTALLINE MACROTEC, TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT MAGNACORT, HYDROCORTAMATE HYDROCHLORIDE MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MAGNESIUM SULFATE MAGNESIUM SULFATE IN PLASTIC CONTAINER, MAGNESIUM SULFATE...
FDA Drug Approvals List October 2001 Active Ingredient(s): OXAPROZIN OTC/RX Status: RX Original Abbreviated Application # 075839 Approval Date: 1-OCT-01 Trade Name: MINOXIDIL Dosage Form: SOLUTION Applicant: NOVEX PHARMA Active Ingredient(s): MINOXIDIL OTC/RX Status: RX Original Abbreviated and 505(b)(2) New Drug Applications with Tentative Approval Original Abbreviated Application #: 075834 Tentative Approval Date: 30...
Prescription and OTC Drug Product List 9/2001 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -D- ENDO PHARMS 400MG;5MG N40288 001 NOV 27, 1998 SEP CTEC -D- 400MG;7.5MG N40288 002 NOV 27, 1998 SEP CTEC -D- 400MG;10MG N40288 003 NOV 27, 1998 SEP CTEC -A- + 400MG;5MG N40288 001 NOV 27, 1998 SEP CTEC -A- + 400MG;10MG N40288 003 NOV 27, 1998 SEP CTEC -A- + 400MG;7.5MG...
Prescription and OTC Drug Product List 6/2002 ACTHAR GEL -D- BC + QUESTCOR PHARMS 40 UNITS/ML N08372 006 JUL DISC -A- @ 40 UNITS/ML N08372 006 JUL DISC DIATRIZOATE SODIUM SOLUTION; ORAL, RECTAL HYPAQUE -D- AMERSHAM HLTH 40% N11386 003 JUL DISC -A- @ 40% N11386 003 JUL DISC DICLOFENAC SODIUM GEL; TOPICAL SOLARAZE -A- + BIOGLAN PHARMA 3% N21005 001 OCT 16, 2000 JUL CAHN -D- + BIOGLAN PHARMA PLC 3% N21005 001 OCT 16, 2000 JUL CAHN...
FDA Drug Approvals List- May 1999 Efficacy Supplemental New Drug Applications Application #: 020584 Efficacy Supplement#: 003 Type: SE2 to Original New Drug Application Approval Date: 27-MAY-99 Trade Name: LODINE XL Dosage Form: TABLET, EXTENDED RELEASE Applicant: WYETH AYERST LABORATORIES INC Active Ingredient(s): ETODOLAC OTC/RX Status: RX Efficacy Claim: For the management of the signs and symptoms of...
Drug Approvals October 1996 Drug Approvals for October 1996 Definitions and Notes October 1996 Original New Drug Applications Original Application #: 019821 Approval Date: 28-OCT-96 Trade Name: SORIATANE Chemical Type: 2 Therapeutic Potential: S Dosage Form: CAPSULE Applicant: HOFFMAN-LAROCHE Active Ingredient(s): ACITRETIN OTC/RX Status: RX Indication(s): Treatment of severe psoriasis Original Application #:...
Drug Approvals September 1996 CATARRHALIS TO THE INDICATIONS AND USAGE SECTION Approvable Original New Drug Applications Original Application #: 020535 Approvable Date: 30-SEP-96 Trade Name: DURACT Dosage Form: CAPSULE Applicant: WYETH AYERST LABORATORIES INC Active Ingredient(s): BROMFENAC SODIUM OTC/RX Status: RX Original Application #: 020690 Approvable Date: 19-SEP-96 Trade Name: ARICEPT Dosage Form: TABLET...
http://www.fda.gov/cder/da/ddpa92.wpd DEPARTMENT OF HEALTH AND HUMAN SERVICES, PUBLIC HEALTH SERVICE NDA NUMBER APPROVAL DATE (CLASSIFICATION)TRADE NAME (DOSAGE FORM)APPLICANTACTIVE INGREDIENT(S) STRENGTH(S) CLASSIFICATION(S) ***ORIGINAL AND SUPPLEMENTAL NDAs*** FOR NEW DRUG PRODUCTS 20 166 SODIUM THIOSULFATE DEPT ARMY SODIUM THIOSULFATE 02 14 92 (INJECTABLE) FORT DETRICK, MD 250MG/ML (7* S**) 21702 (ANTIDOTE) [TREATMENT...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, MACRODANTIN to NYTOL Trade Names of Some Commonly Used Drugs TRADE AND GENERIC NAMES OF COMMONLY USED DRUGS MACRODANTIN to NYTOL Trade Name Generic MACRODANTIN Nitrofurantoin MANDELAMINE Methenamine MANDOL Cefamandole MAREZINE Cyclizine MARINOL Dronabinol MATULANE Procarbazine MAVIK Trandolapril MAXALT Rizatriptan MAXAQUIN Lomefloxacin MAZANOR Mazindol MECLOMEN Meclofenamate MEDROL...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, Kanamycin to Moxalactam Trade Names of Some Commonly Used Drugs GENERIC AND TRADE NAMES OF COMMONLY USED DRUGS Kanamycin to Moxalactam Generic Trade Name Kanamycin KANTREX Ketoconazole NIZORAL Ketoprofen ORUDIS, ORUVAIL Ketorolac TORADOL Labetalol NORMODYNE, TRANDATE Lactulose CEPHULAC, CHRONULAC Lamivudine EPIVIR Lamotrigine LAMICTAL Lansoprazole PREVACID Latanoprost XALATAN Leflunomide ARAVA Levallorphan...
Fluoroquinolones for urinary tract infections (UTIs) - [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 Fluoroquinolones for urinary tract infections (UTIs) - [Medication] - Quest Diagnostics Patient Health Library Fluoroquinolones for urinary tract infections (UTIs) - [Medication] - Quest Diagnostics Patient Health Library Urinary system, Antibiotic,...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, MACRODANTIN to NYTOL Trade Names of Some Commonly Used Drugs TRADE AND GENERIC NAMES OF COMMONLY USED DRUGS MACRODANTIN to NYTOL Trade Name Generic MACRODANTIN Nitrofurantoin MANDELAMINE Methenamine MANDOL Cefamandole MAREZINE Cyclizine MARINOL Dronabinol MATULANE Procarbazine MAVIK Trandolapril MAXALT Rizatriptan MAXAQUIN Lomefloxacin MAZANOR Mazindol MECLOMEN Meclofenamate MEDROL...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, Kanamycin to Moxalactam Trade Names of Some Commonly Used Drugs GENERIC AND TRADE NAMES OF COMMONLY USED DRUGS Kanamycin to Moxalactam Generic Trade Name Kanamycin KANTREX Ketoconazole NIZORAL Ketoprofen ORUDIS, ORUVAIL Ketorolac TORADOL Labetalol NORMODYNE, TRANDATE Lactulose CEPHULAC, CHRONULAC Lamivudine EPIVIR Lamotrigine LAMICTAL Lansoprazole PREVACID Latanoprost XALATAN Leflunomide ARAVA Levallorphan...
Reference Listed Drug Labeling Approved in October 2001 20-388 S-010 Oct 3 COZAAR HYZAAR letter label label losartan potassium tablets losartan potassium/HCTZ tablets 20-386 20-387 S-022 S-018 INFUVITE PEDIATRIC letter label multiple vitamins for infusion 21-265 S-001 Oct 4 FIORICET W/ CODEINE letter - codeine/butalbital/APAP/caffeine capsules 20-232 S-012 FIORINAL W/CODEINE letter - codeine/butalbitall/aspirin/caffeine capsules 19-429 S...
author: USERNAME
http://www.fda.gov/cder/foi/label/2001/20013s8lbl.pdf UNIMED Maxaquin ® (lomefloxacin hydrochloride) Film- coated Tablets DESCRIPTION Maxaquin (lomefloxacin HCl) is a synthetic broad- spectrum antimicrobial agent for oral administrationMaxaquin (lomefloxacin HCl) film- coated tablets are indicated for the treatment of adults with mild to moderate infections...
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Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD):- Part II Trouble navigating this siteLomefloxacin), or SLomefloxacin (Maxaquin): ...
UTI: Part I: Diagnosis, Evaluation, and Principles of Antibiotic Selection Trouble navigating this sitelomefloxacin (Maxaquin ®), and ofloxacin (Floxin®)
