http://www.fda.gov/cder/orange/appendix_a.txt RTU IN PLASTIC CONTAINER, METRONIDAZOLE FLAGYL I.V., METRONIDAZOLE HYDROCHLORIDE FLAGYL, METRONIDAZOLE FLAREX, FLUOROMETHOLONE ACETATE FLAVORED COLESTID, COLESTIPOL HYDROCHLORIDE FLAVOXATE HCL, FLAVOXATE HYDROCHLORIDE FLAXEDIL, GALLAMINE TRIETHIODIDE FLECAINIDE ACETATE, FLECAINIDE ACETATE FLEXERIL, CYCLOBENZAPRINE HYDROCHLORIDE FLEXICORT, HYDROCORTISONE FLOLAN, EPOPROSTENOL SODIUM...
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...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt FACILITIES" 5041 09-Jul-83 TECHNOCHEMIE GMBH LORAZEPAM MFG IN DOSSENHEIM GERMANY 5044 09-Aug-83 SANKYO CHEMICAL INDUSTRIES INC LEVODOPA AS PRODUCED IN THE HIRATSUKA PLANT 5046 30-Jun-83 "SAPEC DIVISION, CERBIOS PHARMA SA" LEUCOVORIN CALCIUM AS MANUFACTURED IN BARBENGO SWITZERLAND 5047 25-Jul-83 PHARMACIA AND UPJOHN INC "ESTRADIOL CYPIONATE USP MANUF-KALAMAZOO, MI FACILITIES ON...
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls JUSTE SAQF MEGLUMINE DIATRIZOATE KLINGE PHARMA GMBH TAMOXIFEN CITRATE YAMANOUCHI PHARMACEUTICAL COMPANY LTD CEFOTETAN AS MANUFACTURED AT TAKAHAGI PLANT MDS NORDION IODINE 125 PRODUCED IN KANATA ISOTOPE PROCESSING FACIL (AECL-KIPE) ACETO CHEMICAL CO INC 5-HYDROXY-L-TRYPTOPHAN-MANUF IN COOPPALLAAN PLANT ZAMBON SPA ACETYLCYSTEINE USP XX (MFG ALMISANO di LONIGO, VICENZA,...
C:\Documents and Settings\TYSONR\My Documents\NDA\N 10-040 Reno-Cys\ tor\ApprovalLtrSPD163.doc DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 NDA 10- 040/ SPD- 163 Bracco Diagnostics, Inc
author: Renee Tyson
C:\Documents and Settings\TYSONR\My Documents\NDA\N 10-040 Reno-Cys\ tor\ApprovalLtrSPD163.doc page 1
author: Renee Tyson
Prescription and OTC Drug Product List 6/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -D- AA PEACHTREE 500MG;10MG N40210 001 AUG 13, 1997 JUN CAHN -A- AA UCB 500MG;10MG N40210 001 AUG 13, 1997 JUN CAHN ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE TABLET; ORAL DARVOCET -A- @ AAIPHARMA LLC 325MG;32.5MG N16844 001 JUN CAHN -D- @...
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 Dexamethasone Acetate Suspension Dexamethasone Sodium Phosphate Dexpanthenol Dextran 40 Dextran 40 in Sodium Chloride Dextran 70 Dextrose < 5% Dextrose- 5%- 70% Dextrose and Sodium Chloride Dezocine 0.03 mg 166.70 + 2.50 mg 2.00 + 0.36 mg 13.89 1.60 units 3.10 + 5.00 mg 1.00 3.57 mcg 1.40 1.86 CSR units 2.69 0.02 ing 0.02 mg 14.30 mcg 1.00 mg 30.00 mg 0.12 mL 7.14 mg 3.00 mg 1.93 mg...
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 10
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 6
author: FDA / CBER
subject: December 1987 Guideline
C:\Documents and Settings\TYSONR\My Documents\Label Reviews\Renog60\ SLR168Approvalltr.doc page 1
author: Renee Tyson
Prescription and OTC Drug Product List 8/1999 Prescription and Over-the-Counter Drug Product List - 19th Edition Cumulative Supplement Number 8: August 1999 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE AZATHIOPRINE SODIUM CAPSULE; ORAL INJECTABLE; INJECTION FEMCET IMURAN - DLT - AB MALLINCKRODT 325MG;50MG;40MG N89102 001 - ADD - AP + FARO PHARMS EQ 100MG BASE...
DDPA June 1995 74-423 CAPTOPRIL MOVA CAPTOPRIL 07-JUN-95 (TABLET) CAGUAS, PR 12.5MG 00725 25MG 50MG 100MG (ANGIOTENSIN CONVERTING ENZYME INHIBITOR) ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 17-911 CLINORIL MERCK SULINDAC 01-JUN-95 (TABLET) WEST POINT, PA 150MG 19486 200MG (LABELING REVISION -- PRECAUTIONS; ADVERSE REACTIONS) 16-744* NORIDAY 1+50-FE SYNTEX FERROUS FUMARATE 02-JUN-95 (TABLET) PALO...
DDPA January 1995 74-124 CIPROFLOXACIN BARR CIPROFLOXACIN 04-JAN-95 (TABLET) POMONA, NY 250MG 10970 500MG 750MG (ANTIBACTERIAL, QUINOLONE) 74-363 CAPTOPRIL GENEVA CAPTOPRIL 30-JAN-95 (TABLET) BROOMFIELD, CO 12.5MG 80038 25MG 50MG 100MG (ANGIOTENSIN CONVERTING ENZYME INHIBITOR) ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 17-521 DEXTROSE 10% BAXTER HLTHCARE DEXTROSE 05-JAN-95 IN PLASTIC CONTAINER ROUND...
