Drug Approvals - N
ANDA 76-009 1/24/03 Nafcillin Injection, USP,- in Galaxy Plastic Container,- Baxter Healthcare Corporation NDA 50-665/S-012 8/23/02 8/30/02 Nalbuphine Hydrochloride Injection, 10 mg/mL & 20 mg/mL NDA 20-388/S8 6/8/00 6/19/02 6/19/02 6/19/02 Nebcin (tobramycin sulfate injection, USP)-Vials and Hyporets, Rx Eli Lilly and Company NDA 50-477/S-024 & 50-519/S-024 4/2/03 4...
http://www.fda.gov/cder/orange/appendix_a.txt
IRRIGANT, NEOMYCIN SULFATE NEOSPORIN, BACITRACIN ZINC NEOSPORIN, GRAMICIDIN NEOSPORIN, NEOMYCIN SULFATE (OTC) NEOTHYLLINE, DYPHYLLINE NEOTRIZINE, TRISULFAPYRIMIDINES (SULFADIAZINE;SULFAMERAZINE; SULFAMETHAZINE) NEPHRAMINE 5.4%, AMINO ACIDS NEPHROFLOW, IODOHIPPURATE SODIUM, I-123 NEPTAZANE, METHAZOLAMIDE NESACAINE, CHLOROPROCAINE HYDROCHLORIDE NESACAINE-MPF, CHLOROPROCAINE ...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt
"ACYCLOVIR ACTIVE SUBSTANCE MANUFACTURED IN KOLODVORSKA, SLOVENIA." 11356 20-Feb-95 RESOLUTION CHEMICALS LTD "SELEGILINE HYDROCHLORIDE MANUFACTURED IN HERTFORSHIRE, UNITED KINGDOM." 11359 20-Feb-95 AMSA ANONIMA MEDICINALI SINTETICI AND AFFINI SPA "ETODOLAC MANUFACTURED IN COMO, ITALY." 11365 23-Feb-95 PHARMACIA AND UPJOHN INC "H324/38 EMULSION FOR INFUSION MANUFACTURED IN...
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls
IN BUDAPEST, HUNGARY PLANTEX LTD CHEM AND PHARM WORKS IMIPRAMINE HYDROCHLORIDE LUNDBECK PHARMACEUTICALS ITALY SPA IMIPRAMINE HYDROCHLORIDE AVENTIS PHARMA SA PROMETHAZINE HCL GRUPPO LEPETIT SPA D-PROPOXYPHENE HYDROCHLORIDE BULK SCHERING AG ETHINYL ESTRADIOL ROCHE COLORADO CORPORATION METFORMIN HYDROCHLORIDE (LA 6023) BOEHRINGER INGELHEIM CHEMICALS INC...
Prescription and Over-the-Counter Drug Product List: 5/2003
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, APAP, AND CAFFEINE -A- AB AXIOM PHARM 325MG;50MG;40MG N89536 001 FEB 16, 1988 MAY CAHN -D- AB HALSEY 325MG;50MG;40MG N89536 001 FEB 16, 1988 MAY CAHN ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -A- AA ABLE 500MG;7.5MG...
author: AUTHOR
Prescription and OTC Drug Product List 6/2002
-A- + GD SEARLE LLC EQ 500MG BASE/VIAL N18353 001 JUL CAHN -D- + SCS EQ 500MG BASE/VIAL N18353 001 JUL CAHN MIDAZOLAM HYDROCHLORIDE INJECTABLE; INJECTION MIDAZOLAM HCL -A- AP ABBOTT EQ 1MG BASE/ML N75857 001 JUL 22, 2002 JUL NEWA -A- AP EQ 5MG BASE/ML N75857 002 JUL 22, 2002 JUL NEWA MIDODRINE HYDROCHLORIDE TABLET; ORAL PROAMATINE -A- + SHIRE LABS 5MG N19815 002 SEP 06,...
Guideline on Validation of the Limulus Amebocyte Lysate Test As An End-Product Endotoxin Text for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices
Bulk, Group C Meningococcal Polysaccharide Vaccine Group A Meningococcal Polysaccharide Vaccine Group C Meningococcal Polysaccharide Vaccine Group A and C Menotropin Meperidine HCl Injection Mephentermine Sulfate Mepivacaine HCl Mepivacaine HCl and Levonordefrin Meprobamate Injection Meprylcaine HCI and Epinephrine Mercaptomerin Sodium Mersalyl with theophylline Merethoxylline...
author: FDA / CBER
subject: December 1987 Guideline
FDA Drug Approvals List- March 1998
Drug Approvals for March 1998 Definitions and Notes March 1998 Original New Drug Applications Original Application #: 020827 Approval Date: 30-MAR-98 Trade Name: MONISTAT 3 Chemical Type: 3 Therapeutic Potential: S Dosage Form: CREAM Applicant: ADVANCED CARE PRODUCTS Active Ingredient(s): MICONAZOLE NITRATE OTC/RX Status: OTC Indication(s): For the over-the-counter treatment of...
http://www.fda.gov/cder/da/ddpa93.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 18 936 PROZAC LILLY FLUOXETINE HYDROCHLORIDE 12-23-92 (CAPSULE) INDIANAPOLIS, IN EQ 10MG BASE (SUPPL) 46285 (NEW STRENGTH) 19 627...
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 Methylprednisolone...
TOXICOLOGY PROFILES/COMBINATIONS
TOXICOLOGY PROFILES/COMBINATIONS Any profile component may be ordered individually on the LabCorp request form. Drug Abuse Profile (Routine), Urine (7-Drugs) - GC/MS confirmation included at no charge...794388 - GC/MS confirmation with added charge...725788 Profile Includes - Amphetamines - Barbiturates - Benzodiazepines - Cannabinoids (Marijuana) - Cocaine Metabolite - Opiates -...
George Bikhazi, MD
In order for our site to display correctly you will need a newer version of your web browser. >" onFocus="javascript:this.value='';"/> About St. American Journal of Obstetrics and Gynecology 191:1183-1191, 2004. Bikhazi GB, Bajwa ZH, Davis DJ, Lecomte D, Hubbard RC, Kuss M, Talwalker S:- Analgesic activity of intravenous parecoxib sodium, ketorolac,- and morphine after...
author: St. Jude Children's Research Hospital
George Bikhazi, MD
In order for our site to display correctly you will need a newer version of your web browser. >" onFocus="javascript:this.value='';"/> About St. American Journal of Obstetrics and Gynecology 191:1183-1191, 2004. Bikhazi GB, Bajwa ZH, Davis DJ, Lecomte D, Hubbard RC, Kuss M, Talwalker S:- Analgesic activity of intravenous parecoxib sodium, ketorolac,- and morphine after...
author: St. Jude Children's Research Hospital
George Bikhazi, MD
In order for our site to display correctly you will need a newer version of your web browser. Lauderdale Memphis, TN- 38105-2974- USA Phone: (901) 495-4784 FAX: (901) 495-5072 Education MD - American University of Beruit, Lebanon Research Interests Pharmacology of investigational drugs Neuromuscular blocking agents, narcotics, benzodiazepines, hypnotics and reversal agents in...
author: St. Jude Children's Research Hospital
George Bikhazi, MD
In order for our site to display correctly you will need a newer version of your web browser. >" onFocus="javascript:this.value='';"/> About St. American Journal of Obstetrics and Gynecology 191:1183-1191, 2004. Bikhazi GB, Bajwa ZH, Davis DJ, Lecomte D, Hubbard RC, Kuss M, Talwalker S:- Analgesic activity of intravenous parecoxib sodium, ketorolac,- and morphine after...
author: St. Jude Children's Research Hospital
George Bikhazi, MD
In order for our site to display correctly you will need a newer version of your web browser. >" onFocus="javascript:this.value='';"/> About St. Lauderdale Memphis, TN- 38105-2974- USA Phone: (901) 495-4784 FAX: (901) 495-5072 Education MD - American University of Beruit, Lebanon Research Interests Pharmacology of investigational drugs Neuromuscular blocking agents, narcotics,...
author: St. Jude Children's Research Hospital
Forensic Product Ordering
- - Product # Kit Name 103619 Alfentanil 105219-I Amphetamine 109319 Amphetamine (Ultra) 105519 Anileridine 109119 Apomorphine 100919 Azaperone 100119 Barbiturate Group 100219 Benzodiazepine Group 101019 Boldenone 100319 Bronchodilator Group 103719-I Bumetanide 103819 Buprenorphine 108719 Buspirone 101119 Butorphanol 106419 Caffeine/Pentoxifylline 103919 Carfentanil 101219...
Specificity Table TOX.xls
Tested (ng/ ml) Novacain Procaine Anesthetic 100,000 Novicet Vincamine Vasodilator 100,000 Nubain Nalbuphine Narcotic analgesic 1,000,000 Numorphan Oxymorphone Narcotic analgesic 100,000 OPI 41,000 Numorphan metabolite Oxymorphone metab.( Noroxymorphone) Oxymorphone metabolite 300,000 Nupercaine Dibucaine Anesthetic 1,000,000 THC 100,000 Nutrasweet Aspartame Sweetener 100,000...
author: Biosite Incorporated
Specificity Table TOX.xls page 19
author: Biosite Incorporated
Medicines, Ethics and Practice Number 28, July 2004 page 10
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 Methylprednisolone...
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 Nelfinavir...
Maximum Recommended Therapeutic Dose (MRTD) Database
Maximum Recommended Therapeutic Dose (MRTD) Database (1,235 pharmaceuticals) A -- B- - C -- D -- E -- F-G -- H-K -- L -- M -- N -- O -- P -- Q-R -- S -- T -- U-Z MRTD--- (mg/kg--- bw/day) -- Generic Chemical Name Chemical Structure (SMILES Code) 3.00000-- Acemetacin C1=C(OC)C=C3C(=C1)N(C(=O)C2=CC=C(Cl)C=C2)C(C)=C3CC(=O)OCC(O)=O 0.20000-- Acenocoumarol C1=CC=C3C(=C1)OC(=O)C(C(CC(C)=O...
Research Reporting summer 2003b
BC Children John Forbes A retrospective review of a cohort of HIV infected and HIV exposed children (infants born to HIV positive mothers) to determine response and adverse effects Karim Khan Glucocorticoid osteoporosis, vertebral compression fractures and back pain; a case report Carolyne Montgomery Nalbuphine for the treatment of opiod- induced pruritus...
author: dszeryk
subject: Research Reporting summer 2003b
LIST OF APPROVED DRUGS FOR WHICH ADDITIONAL PEDIATRIC INFORMATION
DOCKET NO Anesthetic, Critical Care And Addiction Drug Products Bupropion Treatment of depression Metabolic And Endocrine Drug Products Dexmedetomidine Sedation of initially intubated and mechanically ventilated patients in an ICU setting Prolonging the time to recurrence of supraventricular tachycardia Anesthetic, Critical Care And Addiction Drug Products Isotretinoin...