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...
Questcor
Marketed Products: Glofil ® -125 Glofil ®-125 (sodium iothalamate I-125 Injection) is a sterile, nonpyrogenic aqueous injection containing approximately 1 mg sodium iothalamate per mL., and 0.9 percent benzyl alcohol as a preservative - To Order Glofil ®-125 Glofil ®-125 is available from Questcor Pharmaceuticals...
Questcor
Marketed Products: Glofil ® -125 PATIENT PRESENTATION Ms Selected chemistry results include total protein 7.6 g/dL, albumin 4.8 g/dL, BUN 13 mg/dL, creatinine 0.8 mg/dL, K+ 4.1 mmol/L protein -0.16 g/day (normal 0-0.15/day) Her review of systems was essentially negative, and her physical exam was normal The Cockcroft-Gault calculated creatinine clearance...
Questcor
Marketed Products: Glofil ® -125 PATIENT PRESENTATION Ms HISTORY In January 1982, the patient presented with nephrotic syndrome with a 24 hr In 1982, the patient's weight was 70 Kg (154 lb), ht The Cockcroft-Gault creatinine clearance value was 88 mL/min/1.73 m2, the measured 24 hr In June 1986, I-iothalamate GFR was 66 mL/min/1.73 m2, while Cockcroft...
Questcor
Marketed Products: Glofil ® -125 Because the Glofil ®-125 GFR test is a radiologic assay that uses I-125 iothalamate as a marker, clinicians might reasonably ask about patient safety Citing T Rolin reported that the dosimetry for a patient with normal GFR (97 mL/min/1.73 m2) and weighing 70kg is 5.03 millirem (mrem) Bethesda, Md: NCRP ...
Questcor
Marketed Products: Glofil ® -125 Indicated for evaluation of glomerular filtration in the diagnosis or monitoring of patients with renal disease ( Consensus panel ) Cardiovascular or renovascular disease Diabetes patients Kidney donors/recipients Patients undergoing nephrotoxic chemotherapy treatments Pediatric patients with renal disease Glofil ®-125 ...
Prescription and OTC Drug Product List 1/2000
Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 1: January 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST PRESCRIPTION DRUG PRODUCT LIST 1 20TH EDITION ADDITIONS/DELETIONS FOR RX DRUG PRODUCT LIST / CUMULATIVE SUPPLEMENT NUMBER 1 / JAN'2000 - ADD - CALCIUM CHLORIDE CEFTIBUTEN DIHYDRATE - ADD -...
FDA Drug Approvals List
Active Ingredient(s): NEDOCROMIL SODIUM OTC/RX Status: RX Efficacy Claim: Extending the approved use to the pediatric population of 6-11 years of age Approvable Original New Drug Applications Original Application #: 019781 Approvable Date: 31-MAR-97 Trade Name: PROMETRIUM Dosage Form: CAPSULE Applicant: SCHERING PLOUGH CORP Active Ingredient(s): PROGESTERONE OTC/RX Status: RX...
http://www.questcor.com/pdf/glofil.pdf
GLOFIL - 125 Sodium Iothalamate I- 125 Injection, USP NDC 63004- 7729- 2 Canadian License #613 DESCRIPTION General GLOFIL - 125 (Sodium Iothalamate I- 125 Injection) is a sterile, nonpyrogenic aqueous injection containing approximately 1 mg sodium iothalamate per mL, and 0.9 percent benzyl alcohol as a preservative INDICATIONS AND...
http://www.questcor.com/pdf/glofil.pdf page 1
chrmscat.p65 page 1
author: cxm9300
Prescription and OTC Drug Product List 6/2002
-D- + WYETH AYERST 20,000 UNITS/VIAL N17055 003 JUN DISC -A- @ 20,000 UNITS/VIAL N17055 003 JUN DISC CHORIONIC GONADOTROPIN -D- + STERIS 2,000 UNITS/VIAL N17016 011 FEB 16, 1990 JUN DISC -A- @ 2,000 UNITS/VIAL N17016 011 FEB 16, 1990 JUN DISC GRANISETRON HYDROCHLORID E SOLUTION; ORAL KYTRIL -D- + ROCHE EQ 2MG BASE/10ML N21238 001 JUN 27, 2001 JUN DISC -A- @ EQ 2MG BASE/10ML N21238...
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
Conc.( equine) 3.00 mL Dipyridamole 0.14 mg Dobutamine HCI 0.90 mg 5.00 1.10 2.17 3.57 1.80 1.80 1.80 1.80 45.45 5.00 1.25 5.56 11.60 + 0.50 + 35.70 + 71.43 16.70 + 17.20 + 0.70 + 0.70 + 111.00 + 200.00 + 1.00 357.00 0.003 + 0.50 + 166.67 1.00 4.00 0.50 + 1.00 8.77 3.40 + 16.67 1.67 37.70 5.56 40 Dopamine HCI Dopamine HCl in Dextrose Doxapram HCI Injection Doxorubicin HCI for...
author: FDA / CBER
subject: December 1987 Guideline
http://www.freseniushc.com/product/April_1_2001_Update.pdf
April 1 2001 Update Addendum A. Update of Calendar Year 2001 Hospital Outpatient Payment Rates and Coinsurance Amounts Effective April 1, 2001 National Minimum Status Relative Payment Unadjusted Unadjusted APC Group Title Indicator Weight Rate Coinsurance Coinsurance 0001 Photochemotherapy ...
http://www.freseniushc.com/product/April_1_2001_Update.pdf page 11
April 1 2001 Update 7048 Alteplase, 1 mg K 0.38 $18.94 $3.79 $3.79 7049 Filgrastim 480 mcg injection G $273.03 $35.06 $35.06 7315 Sodium hyaluronate, 20 mg G $125.59 $16.83 9000 Na chromate Cr51, per 0.25mCi G $259.36 $34.75 $34.75 9001 Linezolid inj, 200mg J $34.14 $4.57 $4.57 9002 Tenecteplase, 50mg/ ...