http://www.fda.gov/cder/orange/appendix_a.txt ACTHAR GEL, CORTICOTROPIN H.R.-50, HYDROCHLOROTHIAZIDE HABITROL, NICOTINE (OTC) HALCION, TRIAZOLAM HALDOL SOLUTAB, HALOPERIDOL HALDOL, HALOPERIDOL HALDOL, HALOPERIDOL DECANOATE HALDOL, HALOPERIDOL LACTATE HALDRONE, PARAMETHASONE ACETATE HALFAN, HALOFANTRINE HYDROCHLORIDE HALOG, HALCINONIDE HALOG-E, HALCINONIDE HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE HALOPERIDOL INTENSOL,...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt SOTALOL HCL AS MFG & SOLD UNDER THE SIEGFRIED LABEL 3724 21-Feb-80 AVENTIS PHARMA SA "1,A,24-DIHYDROXYCHOLECALCIFEROL" 3725 07-Feb-80 DINAMITE DIPHARMA SPA ISOSORBIDE DINITRATE (ISDN) 3743 10-Mar-80 MEDI PHYSICS INC "CYCLOTRON OPERATION, INDIUM CL (IN 111)MANUFACTURED IN EMERYVILLE, CALIFORNIA." 3746 10-Mar-80 MEDI PHYSICS INC "CYCLOTRON OPERATION, THALLOUS CL (TL-201),...
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls BISACODYL ROCHE DIAGNOSTICS GMBH DIGOXIN PRODUCTS SOLMAG S.P.A DICYCLOMINE HYDROCHLORIDE CHATTEM CHEMICALS INC AMPHETAMINE BULK AND DEXTRO DESOXYEPHEDRINE TAKEDA CHEMICAL INDUSTRIES LTD FOLIC ACID AVENTIS PHARMA SA NORGESTERAL ACETATE OXIME INDUSTRIA CHIMICA MILANESE SPA PROCHLORPERAZINE BASE,PROCHLORPERAZINE MALEATE ANTIBIOTICOS SPA GLIPIZIDE, BULK STARKS ASSOCIATES INC...
Report 501: Congestive Heart Failure · review of current approaches used in the management of the various stages of CHF and practice trends · discussion of diagnostic methodologies · detailed information on novel drugs in development, including diuretics, inotropic agents, vasodilators, neurohumoral antagonists, calcium channel blockers, anticoagulants, antiarrhythmics, endothelin antagonists, gene...
Vasodilators for heart failure - [Medication] - Quest Diagnostics Patient Health Library Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About - References Vasodilators for heart failure - [Medication] - Quest Diagnostics Patient Health Library Vasodilators for heart failure - [Medication] - Quest Diagnostics Patient Health Library Apresazide, Apresoline, cardiac failure, CHF, Congestive heart failure,...
http://www.MTRA.com/home/bioanalytical_listing.pdf Bioanalytical Assay List AAI International, Inc. 2320 Scientific Park Drive, Wilmington, NC 28405 USA Phone: 1.800.575.4AAI (4224) Fax: 1.910.815.2300 Bioanalytical Laboratories 12400 Shawnee Mission Parkway, Shawnee Kansas 66216 (P: 913.248.3000 / F: 913.248.3106) Wegenerstrasse 13, ...
http://www.MTRA.com/home/bioanalytical_listing.pdf page 4 Analyte LLOQ Units Matrix AAI International, Inc. 2320 Scientific Park Drive, Wilmington, NC 28405 USA Phone: 1.800.575.4AAI (4224) Fax: 1.910.815.2300 Bioanalytical Laboratories 12400 Shawnee Mission Parkway, Shawnee Kansas 66216 (P: 913.248.3000 / F: 913.248.3106) Wegenerstrasse 13, ...
duplicates:http://www.aaiintl.com/home/bioanalytical_listing.pdf
Prescription and Over-the-Counter Drug Product List: 10/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN >A> AA VINTAGE PHARMS 500MG/15ML;7.5MG/15ML N40520 001 OCT 30, 2003 OCT NEWA TABLET; ORAL ANEXSIA >D> AA MALLINCKRODT 750MG;10MG N40468 001 OCT 31, 2002 OCT CTNA >A> AA 750MG;10MG N40468 001 OCT 31, 2002 OCT CTNA ALBUTEROL SULFATE TABLET...
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
Prescription and Over-the-Counter Drug Product List: 7/2003 >A> @ FERRING 5,000 UNITS/VIAL N17055 001 JUL CAHN >A> @ 10,000 UNITS/VIAL N17055 002 JUL CAHN >A> @ 20,000 UNITS/VIAL N17055 003 JUL CAHN >D> @ WYETH AYERST 5,000 UNITS/VIAL N17055 001 JUL CAHN >D> @ 10,000 UNITS/VIAL N17055 002 JUL CAHN >D> @ 20,000 UNITS/VIAL N17055 003 JUL CAHN GRANISETRON HYDROCHLORIDE SOLUTION; ORAL KYTRIL >D> @ ROCHE EQ 2MG BASE/10ML N21238 001 JUN 27,...
author: AUTHOR
Prescription and Over-the-Counter Drug Product List: 3/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL FIORICET W/ CODEINE -D- AB + NOVARTIS 325MG;50MG;40MG;30MG N20232 001 JUL 30, 1992 MAR CAHN -A- AB + WATSON PHARMS 325MG;50MG;40MG;30MG N20232 001 JUL 30, 1992 MAR CAHN ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL CODRIX -A- + ANDRX PHARMS 500MG;30MG N40441 001...
author: AUTHOR
FDA Drug Approvals List September 2001 - Drug Approvals for September 2001 Definitions and Notes Original New Drug Applications Original Application #: 021279 Approval Date: 25-SEP-01 Trade Name: FORADIL Chemical Type: 3 Therapeutic Potential: S Dosage Form: POWDER, FOR INHALATION Applicant: NOVARTIS PHARMACEUTICALS CORP Active Ingredient(s): FORMOTEROL FUMARATE OTC/RX Status: RX Indication(s): For the long-term, twice...
Prescription and OTC Drug Product List 9/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST -A- ADEFOVIR DIPIVOXIL -A- TABLET; ORAL -A- HEPSERA -A- + GILEAD 10MG N21449 001 SEP 20, 2002 SEP NEWA ALBUTEROL SULFATE TABLET, EXTENDED RELEASE; ORAL -A- ALBUTEROL SULFATE -A- AB SIDMAK LABS EQ 4MG BASE N76130 002 SEP 26, 2002 SEP NEWA -A- AB EQ 8MG BASE N76130 003 SEP 26, 2002 SEP NEWA VOLMAX -D- BC + MURO EQ 4MG BASE N19604...
Comprehensive List of Current Guidance Documents at the Food and Drug Administration page 29
author: FDA
Prescription and OTC Drug Product List 12/1998 Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 12: December 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST - ADD - ABACAVIR SULFATE ALBUTEROL SULFATE - ADD - SOLUTION; ORAL SOLUTION; INHALATION - ADD - ZIAGEN ALBUTEROL SULFATE - ADD - + GLAXO WELLCOME EQ 20MG BASE/ML N20978 001 - ADD - @ COPLEY PHARM...
Prescription and OTC Drug Product List 7/1998 Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 7: July 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE - ADD - CALFACTANT TABLET; ORAL - ADD - INJECTABLE; INJECTION BUTALBITAL,ACETAMINOPHEN AND CAFFEINE - ADD - INFASURF PRESERVATIVE FREE - ADD - AB + MIKART 500MG...
Prescription and OTC Drug Product List 3/1999 Prescription and Over-the-Counter Drug Product List - 19th Edition Cumulative Supplement Number 3: March 1999 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE CALCIUM CHLORIDE; DEXTROSE; GLUTATHIONE DISULFIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CAPSULE; ORAL CHLORIDE; SODIUM...
FDA Drug Approvals List- January 1999 Drug Approvals for January 1999 Definitions and Notes January 1999 Original New Drug Applications Original Application #: 020781 Approval Date: 27-JAN-99 Trade Name: ZOFRAN ODT Chemical Type: Therapeutic Potential: Dosage Form: TABLET Applicant: GLAXO WELLCOME INC Active Ingredient(s): ONDANSETRON OTC/RX Status: RX Indication(s): For the prevention of chemotherapy and radiation...
http://www.fda.gov/cber/gdlns/guidelst.txt Drug Advertising and Promotional Labeling DDMAC 2 Dissemination of Reprints of Certain October 8, 1996 Advertising Do Published, Original Data Funded Dissemination of Reference October 8, 1996 Do Do Texts Antifungal (topical) February 24, 1990 Biopharmaceutic Drug Information Branch (Draft) Antifungal (vaginal) February 24, 1990 Do Do Food-Effect Bioavailability and December 30, 1997...
FDA Drug Approvals List- June 1999 ROBINS COMPANY Active Ingredient(s): ISOSORBIDE MONONITRATE OTC/RX Status: RX Application #: 018074 Labeling Supplement#: 029 To Original New Drug Application Approval Date: 16-JUN-99 Trade Name: PHENDIMETRAZINE TARTRATE Dosage Form: CAPSULE, EXTENDED RELEASE Applicant: EON LABORATORIES Active Ingredient(s): PHENDIMETRAZINE TARTRATE OTC/RX Status: RX Application #: 012940...
FDA Drug Approvals List- December 1998 Drug Approvals for December 1998 Definitions and Notes December 1998 Original New Drug Applications Original Application #: 020998 Approval Date: 31-DEC-98 Trade Name: CELEBREX Chemical Type: 1 Therapeutic Potential: P Dosage Form: CAPSULE Applicant: GD SEARLE AND CO Active Ingredient(s): CELECOXIB OTC/RX Status: RX Indication(s):For the signs and symptoms of osteoarthritis and...
DDPA May 1995 ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 19-915 MONOPRIL BRISTOL MYERS SQUIBB FOSINOPRIL SODIUM 02-MAY-95 (TABLET) PRINCETON, NJ 10MG 08543 20MG 40MG (LABELING REVISION -- CLINICAL PHARMACOLOGY; INDICATIONS AND USAGE; ADVERSE REACTIONS; DOSAGE AND ADMINISTRATION) 18-206* LO/OVRAL-28 WYETH AYERST LABS ETHINYL ESTRADIOL 03-MAY-95 AND FERROUS FUMARATE PHILADELPHIA, PA 0.03MG (TABLET)...
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...
DDPA May 1996 Drug and Device Product Approvals for May 1996 ***ORIGINAL AND SUPPLEMENTAL NDAs*** FOR NEW DRUG PRODUCTS 16-191 SORBITRATE ZENECA ISOSORBIDE DINITRATE 01-APR-96 (TABLET, SUBLINGUAL) WILMINGTON, DE 2.5MG (SUPPL-033) 19850 5MG (VASODILATOR) [MET CONDITIONS FOR APPROVAL PER FEDERAL REGISTER NOTICE OF AUGUST 3, 1984 (49 FR 31151)] 16-192 SORBITRATE ZENECA ISOSORBIDE ...
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;...
