http://www.fda.gov/cder/orange/appendix_a.txt 2, BUTABARBITAL SODIUM SARISOL, BUTABARBITAL SODIUM APPENDIX A PRODUCT NAME INDEX SATRIC, METRONIDAZOLE SCABENE, LINDANE SCANDONEST L, LEVONORDEFRIN SCANDONEST PLAIN, MEPIVACAINE HYDROCHLORIDE SCLEROSOL, TALC SCRUBTEAM SURGICAL SPONGEBRUSH, HEXACHLOROPHENE SEASONALE, ETHINYL ESTRADIOL SECOBARBITAL SODIUM, SECOBARBITAL SODIUM SECONAL SODIUM, SECOBARBITAL SODIUM SECREFLO, SECRETIN...
FDA Drug Approvals List March 2002 - Drug Approvals for March 2002 Definitions and Notes Original New Drug Applications Original Application #: 020855 Approval Date: 21-MAR-02 Trade Name: MESNA Chemical Type: 3 Therapeutic Potential: S Dosage Form: TABLET Applicant: ASTA MEDICA AG Active Ingredient(s): MESNA OTC/RX Status: RX Indication(s): For the use as a prophylactic agent in reducing the incidence of ifosfamide...
DDPA February 1996 THERE ARE NO ORIGINAL ABBREVIATED AND 505(b)(2) NDAs WITH TENTATIVE APPROVALS FOR FEBRUARY 1996 ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 20-123 OMNIS CAN NYCOMED GADODIAMIDE 05-FEB-96 (INJECTABLE) WAYNE, PA 287MG/ML 19087 (LABELING REVISION -- INDICATIONS AND USAGE; DOSAGE AND ADMINISTRATION) 19-099 DOPAMINE HCL AND MCGAW DOPAMINE HYDROCHLORIDE 07-FEB-96 DEXTROSE 5% IRVINE, CA...
DDPA January 1996 74-467 RANITIDINE GENEVA PHARM RANITIDINE 31-JAN-96 (TABLET) BRO OMFIELD, CO 150MG 80038 300MG (HISTAMINE H-2 RECEPTOR ANTAGONIST) 74-475 TERFENADINE BAKER NORTON TERFENADINE 31-JAN-96 (TABLET) MIAMI, FL 60MG 33178 (ANTIHISTAMINE) ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 20-280 GENOTROPIN PHARMACIA SOMATROPIN, BIOSYNTHETIC 20-DEC-95 (INJECTABLE) COLUMBUS, OH 5.8MG/VIAL 43216 ...
Drug Approvals for December 1997 Also provides for the addition of Haemophilus influenzae to the presently approved indication for secondary bacterial infections of acute bronchitis Application #: 020522 Efficacy Supplement#: 004 Type: SE1 to Original New Drug Application Approval Date: 17-DEC-97 Trade Name: NUTROPIN AQ Dosage Form: INJECTABLE Applicant: GENENTECH INC Active Ingredient(s): SOMATROPIN, BIOSYNTHETIC...
http://www.fda.gov/cder/da/ddpa93.wpd 03 158 ORETON METHYL SCHERING METHYLTESTOSTERONE 01 07 93 (TABLET) KENILWORTH, NJ 10MG 07033 (REVISED LABELING PRECAUTIONS) 50 590 TIMENTIN SMITHKLINE BEECHAM CLAVULANATE POTASSIUM 01 07 93 (INJECTABLE) PHILADELPHIA, PA EQ 100MG ACID/VIAL 19101 TICARCILLIN DISODIUM EQ 3GM BASE/VIAL (REVISED LABELING PRECAUTIONS) 50 590 TIMENTIN SMITHKLINE BEECHAM ...
Rosco A/S - Neo-Sensitabs - Neo-Sensitabs REF - Products in alphabetical order Diffusible amount µg Code -A - - - - 70012 -Amikacin - 40 AMIKA 70112 -Amoxycillin - 30 AMOXY 70212 -Amoxycillin+Clavulanate - 30+15 AM+CL 70312 -Ampicillin - 2.5 AMP.L 70412 -Ampicillin - 33 AMP33 70512 -Apramycin (VET) - 40 APRAM 70612 -Azithromycin - 30 AZITR 70712 -Aztreonam - 30 AZTRM -B - - - - 70812 -Bacitracin - 40...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt LISINOPRIL CRUDE AS MFG IN COURBEVOIE AND HAM FRANCE 14537 19-Nov-99 FUJISAWA PHARMACEUTICAL CO LTD FK8453 DRUG SUBSTANCE AS MFG IN HYOGO AND OSAKA JAPAN 14538 09-Nov-99 SICOR DE MEXICO SA DE CV AMCINONIDE AS MFG IN LERMA MEXICO 14539 18-Nov-99 "UQUIFA ITALIA, S.P.A." CLINDAMYCIN HYDROCHLORIDE USP AS MFG IN MILAN ITALY 14540 18-Nov-99 DIOSYNTH BV TESTOSTERONE UNDECANOATE AS MFG IN...
Genzyme Tissue Repair 2 65009 Revision C 10/ 2002 Table 1 Patient Demographics and Characteristics Final Status Total Treated Patients n Survived n (%) Died Before Initial Takedown n (%) Died After Initial Takedown and Before Final Takedown n (%) Died After Final Takedown and Prior to Discharge n (%) Died After Discharge n (%) Number of Patients 552 478 (86.6) 24 (4.3) 25 (4.5) 24 ...
author: MIS
Penicillins for pneumonia - [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 Penicillins for pneumonia - [Medication] - Quest Diagnostics Patient Health Library Penicillins for pneumonia - [Medication] - Quest Diagnostics Patient Health Library Lungs and airways, Amoxicillin, amoxicillin with clavulanate, amoxicillin with clavulanate...
1998 Warning Letters and Untitled Letters to Pharmaceutical Companies DDMAC 3/13 3/18 Selegiline Tablets Lederle Laboratories DDMAC 3/18 4/3 Skin-Cap Cheminova International DLNDC 3/4 6/5 Timentin (ticarcillin disodium/clavulanate postassium) SmithKline Beecham DDMAC 3/18 4/3 Various Unapproved Prescription Drugs Longevity Products DLND 3/3 6/5 Zyrtec (certirizine HCl) Tablets Pfizer DDMAC 3/4 4/3 April Accolate (zafirkulast) Tablets Zeneca...
C:\Data\My Documents\50658.S9.Ap.DOC DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville MD 20857 NDA 50- 590/ S- 040 NDA 50- 658/ S- 009 GlaxoSmithKline Attention: Deneen Stewart, Ph
author: Susmita Samanta
C:\Data\My Documents\50658.S9.Ap.DOC page 1
author: Susmita Samanta
C:\Data\My Documents\50590.ap.51302.DOC page 1
author: Susmita Samanta
http://www.demegen.com/articles/CF_P113D.pdf ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, 0066- 4804/ 01/$ 04.00 0 DOI: 10.1128/ AACpotassium phosphate buffer (adjusted to pH 7.4) to a concentration of 1 10 5 to 8 10 5 CFU/ ml
http://www.demegen.com/articles/CF_P113D.pdf page 2
Genzyme Tissue Repair page 5
author: MIS
Microsoft Word - DSD0001A Neo-Sensitabs, generel med liste.doc 70012 Amikacin 40 µg 70112 Amoxycillin 30 µg 70212 Amoxycillin+ Clavulanate 30+ 15 µg 81012 Amphotericin B 10 µg 70312 Ampicillin 2.5 µg 70412 Ampicillin 33 µg 83112 Ampicillin + Sulbactam 30+ 30 µg 70512 Apramycin 40 µg 70612 Azithromycin 30 µg 70712 Aztreonam 30 µg 70812 Bacitracin 40 U 70912 Cefaclor 30 µg 71012...
author: md
#541 poster Bozdogan (Page 1) Activities of Cell Wall Inhibitors Towards Vancomycin- resistant Staphylococcus aureus( VRSA) Isolated at the Hershey Medical Center Buelent Bozdogan, & Peter C
Reference Listed Drug Labeling Approved in March 2002 Approval Date Product Name Active Ingredient(s) Dosage Form NDA No Supp No Mar 1 BICILLIN C-R letter - penicillin G benzathine/ procaine injection 50-138 S-219 - BICILLIN L-A letter - penicillin G benzathine/ procaine injection 50-141 S-215 - COLY-MYCIN S letter - colistin & neomycin sulfates/thonzonium Br /hydrocortisone acetate otic suspension 50-356 S-045 - CUROSURF letter label...
author: USERNAME
Reference Listed Drug Labeling Approved in May 2002 -- COUMADIN letter -- warfarin Na tablet 09-218 SLR 098 - COUMADIN letter - warfarin Na tablet 09-218 SLR 099 May 3 DURICEF letter label cefadroxil monohydrate capsule 50-528 SLR 018 DURICEF letter label cefadroxil monohydrate suspension 50-527 SLR 020 DURICEF letter label cefadroxil monohydrate tablet 50-512 SLR 044 PREVACID letter label lansoprazole tablet 21-281 SLR 002 --...
author: USERNAME
PENICILLINS Clinical Pharmacology School of Clinical Medicine - - - Clinical Pharmacology - - - Clinical teaching - - - Therapeutic Topics -Antibacterial Agents Classification Inhibition of Cell Wall Synthesis - - Penicillins - - Cephalosporins/Cephamycins - - Monobactams - - Carbapenems - - Vancomycin Inhibtion of Protein Synthesis - - Macrolides - -...
ANTIMICROBIAL THERAPY ANTIBACTERIAL AGENTS - Click here for antimicrobial use in meningitis and pneumonia - CLASSIFICATION - l------- Bacteriocidal agents act primarily by killing bacteria l------- Bacteriostatic agents act primarily by arresting bacterial growth - MECHANISMS OF ACTION - l Inhibition of cell wall synthesis Penicillins------ -------- ALL based on beta- lactam ring Cephalosporins...
ANTIMICROBIAL THERAPY page 4
