http://www.fda.gov/cder/orange/appendix_a.txt SODIUM, AMINOSALICYLATE SODIUM PACERONE, AMIODARONE HYDROCHLORIDE PACLITAXEL, PACLITAXEL PAGITANE, CYCRIMINE HYDROCHLORIDE PAMELOR, NORTRIPTYLINE HYDROCHLORIDE PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM PAMINE FORTE, METHSCOPOLAMINE BROMIDE PAMINE, METHSCOPOLAMINE BROMIDE PANCURONIUM BROMIDE, PANCURONIUM BROMIDE PANCURONIUM, PANCURONIUM BROMIDE PANDEL, HYDROCORTISONE PROBUTATE...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt IN CAPE PROVINCE, SOUTH AFRICA" 6428 18-Jun-86 KATWIJK CHEMIE BV VALPROIC ACID AS MFG IN THE NETHERLANDS 6430 17-Jun-86 "DC CHEMICAL CO., LTD" "HEXACHLOROPHENE MANUFACTURED IN KYUNG BUK, KOREA." 6437 18-Jun-86 HONEYMEAD PRODUCTS CO "EDIBLE LIQUID SOYBEAN OIL MANUFACTURED IN MANKATO, MINNESOTA." 6440 27-Jun-86 NORDION INTERNATIONAL INC "IODINE 123 CP VCR 804-2 MANUFACTURED IN...
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls Arthur Shaw CDER User $ ($) $ ($) $ ($) $ ($) $ $ () $ - () - $ $ () $ - () - -- -- $ ($) $ ($) $ ($) $ ($) / / // -- - - : : :: : () () () () () - $ $ () $ - () - $ $ () $ - : :: : 4Q2003 TYPE2ACTIVEEXCEL DMF # SUBMIT DATE HOLDER SUBJECT CENTRAL SOYA SOYBEAN STEROL PRODUCTS INTERNATIONAL SPECIALTY PRODUCTS POLYVINYL PYRROLIDONE-IODINE 10 MALLINCKRODT CHEMICAL INC PARZONE BITARTRATE ...
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
SSCI Inc.: Selected publications including journal articles, books, and presentations. List of Selected Publications SSCI IncPentamidine Isethionate. -...
author: SSCI Webmaster
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 OO units Pentagastrin 0.006 mg Pentamidine Isethionate 4.00 mg Pentobarbital Sodium Injection 6.00 mg Pentazocine Lactate Injection 0.86 mg Perphenazine 0.14 mg Phenobarbital Sodium Injection 20.00 mg Phenolsulfonphthalein 0.09 mg Phentolamine Mesylate 0.86 mg Pentylenetetrazol 7.14 mg Phenylephrine HCI 0.20 mg Phenytoin Sodium Injection 20.00 mg Physostigmine Salicylate...
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 4
author: FDA / CBER
subject: December 1987 Guideline
February Drug Approvals Drug Approvals for February 1997 Definitions and Notes February 1997 Original New Drug Applications Original Application #: 020723 Approval Date: 27-FEB-97 Trade Name: ALDARA Chemical Type: 1 Therapeutic Potential: S Dosage Form: CREAM Applicant: 3M PHARMACEUTICALS INC Active Ingredient(s): IMIQUIMOD OTC/RX Status: RX Indication(s): Treatment of external genital and perianal warts...
DDPA December 1995 20-545 PROCANBID PARKE DAVIS PROCAINAMIDE HYDROCHLORIDE 14-DEC-95 (TABLET, ANN ARBOR, MI 500MG EXTENDED RELEASE) 48106 1000MG (ANTIARRHYTHMIC) 20-518 RETROVIR GLAXO WELLCOME ZIDOVUDINE 19-DEC-95 (TABLET) RES TRIANGLE PK, NC 300MG 27709 (ANTIVIRAL) 20-535 BROMFENAC SODIUM WYETH AYERST BROMFENAC SODIUM 28-DEC-95 (CAPSULE) RADNOR, PA EQ 25MG BASE 19087 EQ 50MG BASE (NONSTEROIDAL ANTI...
DDPA August 1995 20-401 TIAZAC BIOVAIL DILTIAZEM HYDROCHLORIDE 01-AUG-95 (CAPSULE, SCARBOROUGH, ONTARIO 120MG EXTENDED RELEASE) CANADA 180MG 240MG 300MG 360MG (CALCIUM ION INFLUX INHIBITOR) [HYPERTENSION] 20-465 AZULFIDINE EN-TABS KABI PHARMACIA SULFASALAZINE 02-AUG-95 (TABLET, COLUMBUS, OH 500MG DELAYED RELEASE) 43216 (ANTI-INFLAMMATORY) [TREATMENT OF RHEUMATOID ARTHRITIS] 50-673 CECLOR CD ELI LILLY...
DDPA August 1996 74-635 NAPROXEN SODIUM NOVOPHARM NAPROXEN SODIUM 20-AUG-96 (TABLET) SCARBOROUGH, ONTARIO 220MG CANADA (NONSTEROIDAL ANTI-INFLAMMATORY) 74-570 ACYCLOVIR ROXANE LABS ACYCLOVIR 30-AUG-96 (CAPSULE) COLUMBUS, OH 200MG 43216 (ANTIVIRAL) ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 08-678 ISONIAZID EON MANUFACTURE LABS ISONIAZID 01-AUG-96 (TABLET) LAURELTON, NY 100MG 11413 300MG (LABELING...
DDPA June 1996 74-515 TIMOLOL MALEATE AKRON TIMOLOL MALEATE 17-JUN-96 (SOLUTION) DECATUR, IL EQ 0.25% BASE 62525 (BETA ADRENERGIC BLOCKER) 74-516 TIMOLOL MALEATE AKRON TIMOLOL MALEATE 17-JUN-96 (SOLUTION) DECATUR, IL EQ 0.5% BASE 62525 (BETA ADRENERGIC BLOCKER) 16-096 MINTEZOL MSD THIABENDAZOLE 03-JUN-96 (TABLET, CHEWABLE) WEST POINT, PA 500MG 19486 (LABELING REVISION -- INDICATIONS AND USAGE;...
DDPA March 1996 74-488 RANITIDINE HCL GRANUTEC RANITIDINE HYDROCHLORIDE 05-MAR-96 (TABLET) WILSON, NC EQ 150MG BASE 27896 EQ 300MG BASE (HISTAMINE H-2 RECEPTOR ANTAGONIST) ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 04-570 HEPARIN SODIUM UPJOHN HEPARIN SODIUM 04-MAR-96 (INJECTABLE) KALAMAZOO, MI 1,000 UNITS/ML 49001 5,000 UNITS/ML 10,000 UNITS/ML (LABELING REVISION -- WARNINGS; PRECAUTIONS; ADVERSE...
August Drug Approvals Original Application #: 020508 Approval Date: 29-AUG-96 Trade Name: LAC-HYDRIN Chemical Type: 3 Therapeutic Potential: S Dosage Form: CREAM Applicant: BRISTOL MYERS CO Active Ingredient(s): AMMONIUM LACTATE OTC/RX Status: RX Indication(s): ICHTHYOSIS VULGARIS AND XEROSIS Original Application #: 020532 Approval Date: 26-AUG-96 Trade Name: IVY BLOCK Chemical Type: 1 Therapeutic...
http://www.fda.gov/cder/da/ddpa93.wpd 74 207 NAPROXEN COPLEY NAPROXEN 02 26 93 (TABLET) CANTON, MA 250MG 02021 375MG 500MG (NONSTEROIDAL ANTI INFLAMMATORY) 19 715 DIPENTUM KABI OLSALAZINE SODIUM 01 05 93 (CAPSULE) PISCATAWAY, NJ 250MG 08855 (REVISED LABELING CLINICAL PHARMACOLOGY; PRECAUTIONS; ADVERSE REACTIONS) 09 218 COUMADIN DUPONT WARFARIN SODIUM 02 01 93 (TABLET) WILMINGTON, DE 1MG 19880 2MG 2.5MG 5MG 7.5MG 10MG ...
http://www.medicis.com/products/pi/pi_triaz.pdf Rx Only DESCRIPTION: TRIAZ ® (benzoyl peroxide) 3%, 6%, and 9% Gels, TRIAZ ® (benzoyl peroxide) 3%, 6%, and 9% Cleansers and TRIAZ ® (benzoyl peroxide) 3%, 6%, and 9% Pads are topical, gel- based, benzoyl peroxide containing preparations for use in the treatment of acne vulgaris.
http://www.medicis.com/products/pi/pi_triaz.pdf page 1
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
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
FUTURE ONCOLOGY Volume 3 #10/11 February/March 1998 FUTURE ONCOLOGY Volume 3 #10/11 February/March 1998 State-of the-Art in the Management of Cancer Update of Prostate Cancer-PART I E EMIOLOGY USA Epidemiology Cancer of the Central Nervous System-Part III Novel Therapeutic Approaches Novel Chemotherapeutics 9-aminocamptothecin Alanosine Diaziquone Dibromodulcitol (DBD) Fluorodeoxyuridine (FdUrd) Hypericin Mivobulin Isethionate ...
3 Year Index (Page 1) FUTURE ONCOLOGY VOLUME 3, NUMBER 1- 12 INDEX MAY 1998 p53 651 Introgen Therapeutics 651 Schering- Plough Research Institute 651 p16 651 Suicide Genes 651 Onyx- 015 654 Human Papillomavirus (HPV) 654 GROWTH FACTORS/ CYTOKINES 654 Epidermal Growth Factor (EGF) Receptor Inhibitors 654 Quinazolines 654 MDX- 447 655 MAb ICR62 655 Interferon as Adjuvant Therapy 655 Tumor Necrosis Factor a ...
author: John Himes
3 Year Index (Page 1) page 2
author: John Himes
