Eli Lilly Japan Receives Additional Approval for Vancomycin Hydrochloride for Injection CANTAB BIOPHARMA FREE Trade Mags Eli Lilly Japan Receives Additional Approval for Vancomycin Hydrochloride for Injection Tokyo (JCNN) - Eli Lilly Japan has announced that it has received additional approval for Vancomycin Hydrochloride Injection 0.5g, its injectable glycopeptide antibiotic for Gram-positive infections?
BioPortfolio BioNews (News & Press Releases) November 2004 Secures License From Medical College Of Georgia To Intellectual Property And Technology For The Treatment Of Human Cognitive Disorders CAMBRIDGE ANTIBODY TECHNOLOGY (CAT)ANNOUNCES PRELIMINARY RESULTS FOR THE YEAR ENDED 30 SEPTEMBER 2004 ABLYNX APPOINTS EDWIN MOSES AS CHAIRMAN OF THE BOARD OF DIRECTORS Dow Pharmaceutical Sciences Appoints Sandra Calman, MD as Director of Clinical...
BioPortfolio Client Press Releases Site Map Secures License From Medical College Of Georgia To Intellectual Property And Technology For The Treatment Of Human Cognitive Disorders CAMBRIDGE ANTIBODY TECHNOLOGY (CAT)ANNOUNCES PRELIMINARY RESULTS FOR THE YEAR ENDED 30 SEPTEMBER 2004 ABLYNX APPOINTS EDWIN MOSES AS CHAIRMAN OF THE BOARD OF DIRECTORS Dow Pharmaceutical Sciences Appoints Sandra Calman, MD as Director of Clinical...
Drug Approvals - Z NDA 19-090/S-0037 10/29/99 - 4/16/03 Zantac (ranitidine hydrochloride) Injection & Premixed Injection GlaxoSmithKline NDA 19-090/S-045 & 19-593/S-033 1/7/02 2/8/02 Zantac (ranitidine hydrochloride) Tablets, Syrup, USP, GELdose Capsules & EFFERdose Tablets and Granules GlaxoSmithKline NDA 18-703/S-061, 19-675/S-025, 20-095/S-013 & 20-251/S-011 1/7/02 2/8/02 Zantac (Ranitidine ...
FACT SHEET TABLE 3 Average Concentrations of Cefepime in Specific Body Fluids (µg/ mL) or Tissues (µg/ g) Rx only HCI ° H2N H2O OCH3 CH3 N N N H H H N N S S O O COOH Cl MAXIPIME Parameter 500 mg IV 1 g IV 2 g IV 0.5 h 38.2 78.7 163.1 1.0 h 21.6 44.5 85.8 2.0 h 11.6 24.3 44.8 4.0 h 5.0 10.5 19.2 8.0 h 1.4 2.4 3.9 12.0 h 0.2 0.6 1.1 Cmax' µg/ mL 39.1 (3.5) 81.7 (5.1) 163.9 (25...
author: K. Notarianni
FACT SHEET page 6
author: K. Notarianni
duplicates:http://www.elan.com/Images/Maxipime_PI_200204_tcm3-4348.pdf
MAX0173 Full PI-4 pager TABLE 3 Average Concentrations of Cefepime in Specific Body Fluids (µg/ mL) or Tissues (µg/ g) Rx only HCI ° H2N H2O OCH3 CH3 N N N H H H N N S S O O COOH Cl MAXIPIME Parameter 500 mg IV 1 g IV 2 g IV 0.5 h 38.2 78.7 163.1 1.0 h 21.6 44.5 85.8 2.0 h 11.6 24.3 44.8 4.0 h 5.0 10.5 19.2 8.0 h 1.4 2.4 3.9 12.0 h 0.2 0.6 1.1 Cmax' µg/ mL 39.1 (3.5) 81.7 (5.1) 163.9 (25...
author: Freelance
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...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt AMOXICILLIN TRIHYDRATE 13779 01-Sep-98 BRISTOL-MYERS AMPICILLIN 13780 01-Sep-98 ACS DOBFAR SPA CEFACLOR 13781 01-Sep-98 TAIWAN BIOTECH CEPHALEXIN 13782 01-Sep-98 GIST BROCADES PENICILLIN G POTASSIUM 13783 01-Sep-98 "ZHEJIAN HISUN PHARMACEUTICAL CO., LTD." "MITOMYCIN AS MANUFACTURED IN JIAOJIANG, ZHEJIANG PROVINE, CHINA" 13784 01-Sep-98 SICOR SPA BLEOMYCIN SULFATE 13785 01-Sep-98...
Prescription and Over-the-Counter Drug Product List: 8/2003 4MG/HR N74607 001 AUG 30, 1996 AUG CRLD >A> AB2 + 0.4MG/HR N74607 001 AUG 30, 1996 AUG CRLD >D> AB2 0.6MG/HR N74559 001 AUG 30, 1996 AUG CRLD >A> AB2 + 0.6MG/HR N74559 001 AUG 30, 1996 AUG CRLD >D> TRANSDERM-NITRO >D> AB2 + NOVARTIS 0.1MG/HR N20144 001 FEB 27, 1996 AUG DISC >A> @ 0.1MG/HR N20144 001 FEB 27, 1996 AUG DISC >D> AB2 + 0.2MG/HR N20144 002 FEB 27, 1996 AUG DISC >A> @ 0.2MG...
author: AUTHOR
Prescription and Over-the-Counter Drug Product List: 6/2003 >D> AP + WYETH AYERST 5,000 UNITS/VIAL N17055 001 JUN DISC >A> @ 5,000 UNITS/VIAL N17055 001 JUN DISC >D> AP + 10,000 UNITS/VIAL N17055 002 JUN DISC >A> @ 10,000 UNITS/VIAL N17055 002 JUN DISC GUANABENZ ACETATE TABLET; ORAL GUANABENZ ACETATE >D> AB WATSON LABS EQ 8MG BASE N74025 002 FEB 28, 1994 JUN CRLD >A> AB + EQ 8MG BASE N74025 002 FEB 28, 1994 JUN CRLD >D> WYTENSIN >D> AB WYETH...
author: AUTHOR
Efficacy Supplements Approved in Calendar Year 1998 DILTIAZEM HYDROCHLORIDE BIOVAIL LABS 20-401 30-Jan-97 30-Jan-98 SE1 12.0 Treatment of chronic stable anginaHYDROCHLORIDE LILLY 20-509 29-Aug-97 25-Aug-98 SE1 11.9 In combination with cisplatin for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB) or metastatic (Stage IV) non-small cell lung cancer
author: Brenda Harmon
NDAs Approved under Subpart H NDAs Approved under Subpart H NDA # Trade Name Generic -Name Clock Date Approval Date AP Time Approval Basis Indication - - - - - - - - 20199 Hivid Zalcitabine 31-Oct-91 19-Jun-92 7.6 S Combination therapy with zidovudine in advanced HIV infection - - - - - - - - 50698 Biaxin Clarithromycin- 2-Nov-92 23-Dec-93 13.7 S Treatment of disseminated mycobacterial infections due to...
author: Darlene Norris
FDA Drug Approvals List February 2001 Dosage Form: INJECTABLE Applicant: ASTRAZENECA UK LTD Active Ingredient(s): MEROPENEM OTC/RX Status: RX Application #: 050622 Labeling Supplement #: 014 To Original New Drug Application Approval Date: 06-FEB-01 Trade Name: SUPRAX Dosage Form: SUSPENSION Applicant: LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO Active Ingredient(s): CEFIXIME OTC/RX Status: RX Application #: 050606...
FDA Drug Approvals List May 2002 - Drug Approvals for May 2002 Definitions and Notes Original New Drug Applications Original Abbreviated Antibiotic Application # 065082 Approval Date: 31-MAY-02 Trade Name: CEFPODOXIME PROXETIL Dosage Form: GRANULE, FOR RECONSTITUTION Applicant: RANBAXY LABORATORIES LTD Active Ingredient(s): CEFPODOXIME PROXETIL OTC/RX Status: RX Original Application #: 021292 Approval Date: 31-MAY...
http://www.fda.gov/cder/foi/label/2001/50606s14lbl.pdf 2.4 PV 1982- A AMP VANCOCIN ® HCl Vancomycin Hydrochloride Capsules, USP Pulvules ® This preparation for the treatment of colitis is for oral use only and is not systemically absorbedvancomycin therapy is desired, use Vancocin ® HCl (Sterile Vancomycin Hydrochloride, USP), IntraVenous, and consult package insert...
http://www.fda.gov/cder/foi/label/2001/50606s14lbl.pdf page 5
http://www.fda.gov/cder/foi/label/2001/50606s14lbl.pdf page 1
V:\DAIDP\PEAT\Approval Letter\N50679SE2.doc NDA 50- 679/ S- 021 Page 3 Rx only 03/ 13/ 03 MAXIPIME ® (Cefepime Hydrochloride) for Injection For Intravenous or Intramuscular Use DESCRIPTION Cefepime hydrochloride is a semi- synthetic, broad spectrum, cephalosporin antibiotic for parenteral administration
author: Raquel Peat
Efficacy Supplements Approved in Calendar Year 2002 (SE1-SE7 AND SE8s ----------- This list is updated quarterly.- Updated through 12/31/02 -------------------- Top of Page ---------- EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2002 (SE8)* Top of Page GENERIC NAME APPLICANT NDA NUMBER SUPP TYPE SUPP NUMBER RECEIPT DATE APPROVAL DATE PRIORITY REVIEW TOTAL APPROVAL TIME (MONTHS) ABACAVIR SULFATE, LAMIVUDINE, AND ZIDOVUDINE GLAXOSMITHKLINE 21-205 SE8...
author: Darlene Norris
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 25 Iu Somatropin Pituitary & Recombinant 0.20 ru Soybean Oil Emulsion 3.13 mL Spectinomycin HCl 57.00 mg Streptokinase 21428.00 IU Streptokinase- Streptodornase (Local) Streptokinase- Streptodornase 0 Streptomycin Sulfate Streptozocin Succinylcholine Chloride Sufentanil citrate Invert Sugar Invert Sugar in Sodium Chloride Sulbactam Sodium Sulfadiazine Sodium Sulfamethoxazole &...
author: FDA / CBER
subject: December 1987 Guideline
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 page 9
author: FDA / CBER
subject: December 1987 Guideline
Corporate Component Name Executive Director US Medical Division Lilly Research Laboratories Eli Lilly and Company 1 PA 1858 AMP VIALS VANCOCIN ® HCl STERILE VANCOMYCIN HYDROCHLORIDE, USP INTRAVENOUS DESCRIPTION Vancocin ® HCl (Sterile Vancomycin Hydrochloride, USP), IntraVenous, is a chromatographically purified, tricyclic glycopeptide antibiotic derived from Amycolatopsis...
author: Bright Bryn A.
Corporate Component Name page 11
author: Bright Bryn A.
Corporate Component Name page 2
author: Bright Bryn A.
