http://www.fda.gov/cder/orange/appendix_a.txt 4, ACETAMINOPHEN TYLENOL W/ CODEINE, ACETAMINOPHEN TYLENOL, ACETAMINOPHEN (OTC) TYLOX, ACETAMINOPHEN TYLOX-325, ACETAMINOPHEN TYMTRAN, CERULETIDE DIETHYLAMINE TYZINE, TETRAHYDROZOLINE HYDROCHLORIDE TZ-3, TIOCONAZOLE (OTC) ** U ** U-CORT, HYDROCORTISONE ACETATE U-GENCIN, GENTAMICIN SULFATE UCEPHAN, SODIUM BENZOATE ULO, CHLOPHEDIANOL HYDROCHLORIDE ULTANE, SEVOFLURANE ULTIVA,...
EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2003 FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - - EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2003 (SE1 -SE7)* and EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2003 (SE8)* - GENERIC NAME APPLICANT NDA NUMBER SUPP TYPE SUPP NUMBER RECEIPT DATE APPROVAL DATE PRIORITY REVIEW TOTAL APPROVAL TIME (MONTHS) INDICATION/DESCRIPTION FLUOXETINE...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt IN APELDOORN, THE NETHERLANDS" 9129 15-May-91 PFANSTIEHL LABORATORIES INC "SUCROSE, N.FSUCROSE OCTASULFATE, AMMONIUM SALT MFG
21135_Venofer.htm Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Venofer (Iron Sucrose) Injection Company:- Luitpold Pharmaceuticals, Inc
author: Paul Stauffer
FDA Drug Approvals List February 2001 Approvable Original New Drug Applications - Original Abbreviated New Drug Applications Original Abbreviated Application # 075402 Approval Date: 28-FEB-01 Trade Name: METAPROTERENOL SULFATE Dosage Form: SOLUTION Applicant: NOVEX PHARMA Active Ingredient(s): METAPROTERENOL SULFATE OTC/RX Status: RX Original Abbreviated Application # 075403 Approval Date: 28-FEB-01 Trade Name:...
Prescription and OTC Drug Product List 11/2000 Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 11: November 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST - ADD - ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE AMOXICILLIN - ADD - TABLET; ORAL TABLET; ORAL - ADD - TRIZIVIR AMOXICILLIN - ADD - + GLAXO WELLCOME EQ 300MG BASE;150MG;300MG N21205 001 - ADD -...
FDA Drug Approvals List November 2000 - Drug Approvals for November 2000 Definitions and Notes Original New Drug Applications Original Application #: 050782 Approval Date: 27-NOV-00 Trade Name: TRADENAME Chemical Type: 3 Therapeutic Potential: S Dosage Form: GEL Applicant: TARGET RESEARCH ASSOCIATES Active Ingredient(s): CLINDAMYCIN PHOSPHATE OTC/RX Status: RX Indication(s): FOR ONCE A DAY TREATMENT OF ACNE VULGARIS...
21136-1-DZ.1-454101-PrepressPdfNoBL.pdf page 11
author: Asura
Advanced Magnetics page 11
author: Merrill Corporation
subject: 10-K text
2000 Warning Letters and Untitled Letters to Pharmaceutical Companies Food and Drug Administration • Center for Drug Evaluation and Research Compliance Activities Search Warning Letters and Untitled Letters to Pharmaceutical Companies 2000 These letters, sorted by month, are supplied by the CDER Freedom of Electronic Information Office
ADVANCED MAGNETICS 2003 10-K page 10
author: Merrill Corporation
subject: ADVANCED MAGNETICS 2003 10-K
Reference Listed Drug Labeling Approved in February 2001 letter label meropenem for injection 50-706 S-007 SUPRAX letter label cefixime oral suspension 50-622 S-014 VANCOCIN HCL letter label vancomycin hydrochloride capsules 50-606 S-014 ZYVOX letter label linezolid tablets linezolid injection linezolid for oral suspension 21-130 21-131 21-132 S-001 S-001 S-001 Feb 8 AVANDIA letter label rosiglitazone maleate tablets 21-071 S-006...
author: USERNAME
M:\Venofer\NDA21135SE2-006\VenoferNDA21135-S-006approvalLetter.doc page 1
author: Melissa Furness
http://www.fda.gov/cder/foi/label/2000/21135lbl.pdf Changes from Baseline in Hemoglobin and Hematocrit End of treatment 2 week follow- up 5 week follow- up Efficacy parameters Venofer® (n= 69) Historical Control (n= 18) Venofer ® (n= 73) Historical Control (n= 18) Venofer ® (n= 71) Historical Control (n= 15) Hemoglobin (g/ dL) 1.0g0.12* * 0.0g0.21 1.3g0.14 ** 1.2g0.17 * Hematocrit (%) 3.1g0.37* * 3.6g0.44 **...
http://www.fda.gov/cder/foi/label/2000/21135lbl.pdf page 8
http://www.fda.gov/cder/foi/label/2000/21135lbl.pdf page 5
http://www.fda.gov/cder/foi/label/2000/21135lbl.pdf page 3
Worthington Deoxyribonucleic Acid and Related Products Multiple Active Sites of Escherichia coli Ribonucleic Acid Polymerases, J Biol Chem 244, 6680, 1969 - Itzhaki, R.: Accessible DNA in Chromatin, Eur J Biochem 47, 27, 1974 - Ivanov, I., Venkov, P., and Markov, G.: Isolation of DNA from Yeast by Chromatography on Hydroxyapatite, Prep Biochem 5, 219, 1975 - Janakidevi, K., Murray, D., Sell, C., and Held, P.: Fluorometric Analysis of DNA...
c and d Compound Molecular Mass / g Volume water / cm 3 formula (a) Glucose C 6 H 12 O 6 8.5 1000 (b) Ribose C 5 H 10 O 5 10.7 500 (c) Glycine C 2 H 5 NO 2 25.7 2000 (d) Sucrose C 12 H 22 O 11 18.5 375 (iv) You are asked to prepare a 100 cm 3 of a solution of ribose (molecular formula, C 5 H 10 O 5 ) at a concentration of 1.0 x 10 mol dm.
author: Cre ICT
Composition of honey. Select item below Question and Answer Archive - Search the SAPS Website - Questions and Answers - Ask SAPS a Question - Links to other sites - - What are the chemical compounds present in sunflower honey?Sucrose 1% Dextrin 0.5% (a polysaccharide formed as an intermediate in the splitting of starch...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE4TEXT.txt CO., INC." "NATURAL & ARTIFICIAL CITRUS FLAVOR # 9185 AS MFG IN PHILADELPHIA, PA." 14975 31-Jul-00 MITSUBISHI CHEMICAL CORP "EXCIPIENTS SUCROSE FATTY ACID ESTERS(SUCROSE STEARIC ACID ESTERS, SUCROSE PALMITIC ACID ESTERS AND SUCROSE LAURIC ACID ESTERS) AS MFG IN YOKKAICHI, MIE PREFECTURE, JAPAN" 14989 24-Aug-00 SHIONOGI QUALICAPS "EDIBLE INKS AS MFG IN NARA, JAPAN"...
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE4EXCEL.xls MITSUBISHI CHEMICAL CORP EXCIPIENTS SUCROSE FATTY ACID ESTERS(SUCROSE STEARIC ACID ESTERS, SUCROSE PALMITIC ACID ESTERS AND SUCROSE LAURIC ACID ESTERS) AS MFG IN YOKKAICHI, MIE PREFECTURE, JAPAN SHIONOGI QUALICAPS EDIBLE INKS AS MFG IN NARA, JAPAN FMC CORP LUSTRECLEAR N MICROCRYSTALLINE CELLULOSE/CARRAGEENAN-BASED COATING AS MFG IN NEWARK, DELAWARE PRONOVA...
http://www.crownsci.com.au/CATORD/clearance/clearance_files/sheet002.htm 0.005% H2O) GR 500mL 2 $52 27275/100G D-Iso-Ascrobic Acid BDH 100g 2 $27 28660.6J Divinylbenzene GPR 500mL 1 $59 55161.3N Dowex 50W-X8 (H) standard grade 50-100mesh 100g 2 $113 55075/500G Duolite resin C225 500g 1 $153 28330.3H Ethyl cellulose 250g 1 $45 7558/100G Extran AP11 Mildly Alkaline (Powder) 100g 2 $8 1.05093.0001 Extrelut refill packs for chromotagraphy 50pk 1 $285 1.04603...
510(k)s Final Decisions Rendered FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH 510(k)s Final Decisions Rendered for January 2000 Some of the documents on this section of the CDRH Website are available only in PDF format and may not be accessible to those with certain disabilities
author: OSM/DID
Geh rt zur Microbiology page 1
