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,...
Nitrates for heart attack and unstable angina - [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 Nitrates for heart attack and unstable angina - [Medication] - Quest Diagnostics Patient Health Library Nitrates for heart attack and unstable angina - [Medication] - Quest Diagnostics Patient Health Library Heart and circulation, Heart problems,...
Nitrates for coronary artery disease - [Medication] - Quest Diagnostics Patient Health Library Nitrates for coronary artery disease Examples Brand Name Chemical Name Nitro-Dur, Nitrolingual, Nitrostat, Transderm-Nitro nitroglycerin Dilatrate-SR, Isordil, Sorbitrate isosorbide dinitrate Imdur, ISMO isosorbide mononitrate Nitrates may be given in a pill or spray form that is placed under the tongue (sublingual).
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,...
1997 Warning Letters and Notice of Violation Letters to Pharmaceutical Companies Food and Drug Administration • Center for Drug Evaluation and Research Compliance Activities Search Warning Letters and Untitled Letters to Pharmaceutical Companies 1997 These letters, sorted by month, are supplied by the CDER Freedom of Electronic Information Office
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...
http://www.fda.gov/cder/ogd/rld/RLD_LABELING_APPROVED_FEB_1999.HTML Firm Date BRETHINE Terbutaline Sulfate Tablet 17-849 032 Novartis Pharms 2-Feb-1999 CHLOROMYCETIN Chloramphenicol Opth Ointment 50-156 038 Parkedale 3-Feb-1999 PRILOSEC Omeprazole Delayed-Release Capsule 19-810 057 Astra Merck 3-Feb-1999 TRANSDERM-NITRO Nitroglycerin Transdermal System 20-144 018 Novartis Pharms 3-Feb-1999 PRIMAXIN Cilastatin Sodium/Imipenem Injection 50-587 50-630...
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 3/2000 Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 3: March 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST LIST 20TH EDITION ADDITIONS/DELETIONS FOR RX DRUG PRODUCT LIST / CUMULATIVE SUPPLEMENT NUMBER 3 / JAN'2000 - MAR'2000 ACETAMINOPHEN; BUTALBITAL AMINOPHYLLINE CAPSULE; ORAL TABLET; ORAL PHRENILIN...
FDA Drug Approvals List- February 1999 Applicant: CONNETICS CORP Active Ingredient(s): BETAMETHASONE VALERATE OTC/RX Status: RX Indication(s):For the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp Original Application #: 020969 Approval Date: 25-FEB-99 Trade Name: UVADEX Chemical Type: 3 Therapeutic Potential: S Dosage Form: SOLUTION Applicant: THERAKOS INC...
H: 55.PDF ANDA 75- 155 October 30, 1998 Kremers Urban Attention: Steven RIsosorbide Mononitrate Extended- release Tablets, 60 mg
author: Unknown
H: 55.PDF page 1
author: Unknown
H: 41AP.PDF ANDA 75- 041 September 22, 1998 Elan Pharmaceutical Research Corporation Attention: Roger Wayne Wiley 1300 Gould Drive Gainesville, GA 30504 Dear Sir: This is in reference to your abbreviated new drug application dated December 31, 1996, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act, for Isosorbide Mononitrate Extended- release Tablets,...
author: Unknown
H: 41AP.PDF page 1
author: Unknown
Drug and Device Approvals March 1995 Drug and Device Approvals-March 1995 ***ORIGINAL AND SUPPLEMENTAL NDAs*** FOR NEW DRUG PRODUCTS 20-092 DILACOR XR RHONE POULENC RORER DILTIAZEM HYDROCHLORIDE 02-MAR-95 (CAPSULE, COLLEGEVILLE, PA 120MG (SUPPL-005)EXTENDED RELEASE) 19426 180MG 240MG (NEW INDICATION -- MANAGEMENT OF CHRONIC STABLE ANGINA) 20-281 ULTRAM JOHNSON RW TRAMADOL HYDROCHLORIDE 03-MAR-95 (TABLET) SPRING HOUSE,...
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...
Drug Approvals for December 1997 Also provides for the addition of Haemophilus influenzae to the presently approved indication for secondary bacterial infections of acute bronchitis Application #: 020522 Efficacy Supplement#: 004 Type: SE1 to Original New Drug Application Approval Date: 17-DEC-97 Trade Name: NUTROPIN AQ Dosage Form: INJECTABLE Applicant: GENENTECH INC Active Ingredient(s): SOMATROPIN, BIOSYNTHETIC...
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), NORTH...
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 ...
ANDAs Approvals - June 2000 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Office Of Generic Drugs ANDAs Approvals June 2000 1
author: USERNAME
ANDAs Approvals - October 2000 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Office Of Generic Drugs ANDAs Approvals - October 2000 Page: 1 1ISOSORBIDE MONONITRATE WESTWARD 10/5/00 TABLETS, 20 MG PHARMACEUTICAL CORP
author: USERNAME
75-147_Isosorbide Mononitrate Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Isosorbide Mononitrate Tablets Company:--Teva Pharmaceuticals, USA Application No.:--75-147 Approval Date:-11/27/1998 - Approval Letter(s) - Printed Labeling - Chemistry Review(s) - Bioequivalence Review(s) - Administrative Document(s) - Correspondence - Back to Drug...
author: Paul Stauffer
75041_Isosorbide.htm Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Isosorbide Mononitrate Extended-Release Tablets Company:- Elan Pharmaceutical Research Corp
author: Paul Stauffer
http://www.fda.gov/cder/ogd/rld/RLD_LABELING_APPROVED_JAN_1999.HTML 20-869 001 Merck Res 4-Jan-1999 LESCOL Fluvastatin Sodium Capsule 20-261 019 Novartis Pharm 4-Jan-1999 CORDARONE Amiodarone Hydrochloride Tablets 200 mg 18-972 017 Wyeth Ayerst Labs 5-Jan-1999 LAMISIL Terbinafine HCl Tablets 20-539 003 Novartis Pharms 5-Jan-1999 LOESTRIN FE 1.5/30 Ethinyl Estradiol/Norethindrone Tablets 17-355 043 Parke Davis 8-Jan-1999 LOESTRIN FE 1/20 Ethinyl...
Prescription and OTC Drug Product List 8/2001 ACTHAR GEL -D- BC + AVENTIS 40 UNITS/ML N08372 006 FEB 06, 1956 AUG CAHN -D- BC + 80 UNITS/ML N08372 008 FEB 06, 1956 AUG CAHN -A- BC + QUESTCOR PHARMS 40 UNITS/ML N08372 006 FEB 06, 1956 AUG CAHN -A- BC + 80 UNITS/ML N08372 008 FEB 06, 1956 AUG CAHN DELAVIRDINE MESYLATE TABLET; ORAL RESCRIPTOR -D- + AGOURON 100MG N20705 001 APR 04, 1997 AUG CRLD -A- 100MG N20705 001 APR 04, 1997 AUG...
