http://www.merck.com/product/usa/pi_circulars/a/aldoril/aldoril_pi.pdf 7843554 TABLETS ALDORIL ® (METHYLDOPA- HYDROCHLOROTHIAZIDE) WARNING This fixed combination drug is not indicated for initial therapy of hypertension.
http://www.merck.com/product/usa/pi_circulars/a/aldoril/aldoril_pi.pdf page 8
http://www.fda.gov/cder/orange/appendix_a.txt 3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE #3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE, ACETAMINOPHEN ACETAMINOPHEN, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN AND CAFFEINE, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN, BUTALBITAL AND CAFFEINE, ACETAMINOPHEN ACETAMINOPHEN,...
Aramine #24 9050625 1 INJECTION ARAMINE ® (METARAMINOL BITARTRATE) DESCRIPTION Metaraminol bitartrate is a potent sympathomimetic amine that increases both systolic and diastolic blood pressure
author: Elsie Huber
duplicates:http://www.merck.com/product/usa/pi_circulars/a/aramine/aramine_pi.pdf
Aramine #24 page 4
author: Elsie Huber
duplicates:http://www.merck.com/product/usa/pi_circulars/a/aramine/aramine_pi.pdf
Aramine #24 page 3
author: Elsie Huber
duplicates:http://www.merck.com/product/usa/pi_circulars/a/aramine/aramine_pi.pdf
Aramine #24 page 2
author: Elsie Huber
duplicates:http://www.merck.com/product/usa/pi_circulars/a/aramine/aramine_pi.pdf
Aramine #24 page 1
author: Elsie Huber
duplicates:http://www.merck.com/product/usa/pi_circulars/a/aramine/aramine_pi.pdf
Microsoft Word - 7843554.doc page 8
Microsoft Word - WMA20673.doc 7843431 TABLETS ALDOMET ® (METHYLDOPA) DESCRIPTION ALDOMET * (Methyldopa) is an antihypertensive drug
duplicates:http://www.merck.com/product/usa/pi_circulars/a/aldomet/aldomet_pi.pdf
Microsoft Word - WMA20673.doc page 5
duplicates:http://www.merck.com/product/usa/pi_circulars/a/aldomet/aldomet_pi.pdf
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 Bulk, Group C Meningococcal Polysaccharide Vaccine Group A Meningococcal Polysaccharide Vaccine Group C Meningococcal Polysaccharide Vaccine Group A and C Menotropin Meperidine HCl Injection Mephentermine Sulfate Mepivacaine HCl Mepivacaine HCl and Levonordefrin Meprobamate Injection Meprylcaine HCI and Epinephrine Mercaptomerin Sodium Mersalyl with theophylline Merethoxylline...
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 2
author: FDA / CBER
subject: December 1987 Guideline
http://www.fda.gov/cder/ogd/rld/13400s85.pdf page 4
http://www.fda.gov/cder/foi/label/2001/11795s11lbl.pdf VISTARIL ® (hydroxyzine pamoate) Capsules and Oral Suspension DESCRIPTION Hydroxyzine pamoate is designated chemically as 1-( p- chlorobenzhydryl) 4- [ 2- (2hydroxyethoxy) ethyl] diethylenediamine salt of 1,1'- methylene bis (2 hydroxy- 3- naphthalene carboxylic acid)
http://www.fda.gov/cder/ogd/rld/11795s16.pdf NDA 11- 795/ S- 016 & 11- 459/ S- 035 Pfizer, Inc
Vitamins, Minerals & Supplements Four bi -layer tablets supply: VITAMINS (Top Layer) Pro-Vitamin A (beta-carotene) 15000 IU Vitamin A (as palmitate) 10000 IU Total Vitamin A Activity 25000 IU Vitamin D-3 (cholecalciferol) 400 IU Vitamin E (d-alpha tocopheryl succinate) 200 IU Vitamin K (phytonadione) 50 mcg Vitamin C 1000 mg Vitamin B-1 (thiamine) 75 mg Vitamin B-2 (riboflavin) 75 mg Niacin (as niacinamide) 100...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt 4Q2003 TYPE2ACTIVETEXT DMF # SUBMIT DATE HOLDER SUBJECT 131 01-Jan-40 CENTRAL SOYA SOYBEAN STEROL PRODUCTS 183 29-Feb-52 INTERNATIONAL SPECIALTY PRODUCTS POLYVINYL PYRROLIDONE-IODINE 10 191 24-Jan-56 MALLINCKRODT CHEMICAL INC PARZONE BITARTRATE (DIHYDROCODEINE BITARTRATE) 240 11-Jan-57 PHARMACIA & UPJOHN 19-NOR-ETHINYLTESTOSTERONE 281 21-Nov-57 UNIMED PHARMACEUTICALS INC...
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 ...
http://www.fda.gov/cber/gdlns/anguidlst.txt Preliminary Guidance -------------------------------------------------------------------------------------------------------------------------------------------------------- Implementation Plan USP injection nomenclature October 2, 1995 Do Do -----------------------------------------------------------------------------------------------------------------------------------------------...
http://www.plantsci.cam.ac.uk/plantsci/admin/forms/ChemCategD.pdf page 2 2 CHEMICALS ABSCISIC ACID METHYL ESTER ABSCISIC ACID ACETOSYRINGONE ACETYL COENZYME- A ACETYL D GALACTOSAMINE (N-) ACETYL D GLUCOSAMINE ACETYL IMIDAZOLE (N-) ACETYLCHOLINE CHLORIDE ACETYLPYRIDINE ADENINE DINUCLEOTIDE Acetylsalicylic acid / Aspirin ACID PHOSPHATASE BUFFER pH 4.9 ACONITIC ...
DDPA June 1995 20-238 TAGAMET HB SMITHKLINE BEECHAM CIMETIDINE 12-JUN-95 (TABLET) PARSIPPANY, NJ 100MG 07054 (HISTAMINE H2- RECEPTOR ANTAGONIST) (OTC) 20-398 PROPULSID JANSSEN CISAPRIDE MONOHYDRATE 13-JUN-95 (SUSPENSION) TITUSVILLE, NJ EQ 1MG BASE/ML 08560 EQ 2MG BASE/ML (UPPER GI TRACT MOTILITY STIMULATOR) 20-393 ATROVENT BOEHRINGER INGELHEIM IPRATROPIUM BROMIDE 22-JUN-95 (SPRAY, METERED)...
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 March 1996 20-193 ELMIRON BAKER NORTON PENTOSAN POLYSULFATE SODIUM 01-MAR-96 (CAPSULE) MIAMI, FL 100MG 33178 (ANTICOAGULANT) 20-486 VANCERIL DS SCHERING BECLOMETHASONE DIPROPIONATE 06-MAR-96 (AEROSOL, METERED) KENILWORTH, NJ 0.084MG/INH 07033 (CORTICOSTEROID) 20-397 ZANAFLEX ATHENA NEUROSCIENCES TIZANIDIN E HYDROCHLORIDE 11-MAR-96 (TABLET) S SAN FRANCISCO, CA EQ 4MG BASE 94080 (ALPHA-2...
DDPA January 1996 20-454 ZANTAC 150 GLAXO WELLCOME RANITIDINE HYDROCHLORIDE 02-JAN-96 (TABLET, CHEWABLE) RES TRIANGLE PK, NC EQ 150MG BASE 27709 (HISTAMINE H-2 RECEPTOR ANTAGONIST) 20-497 FARESTON ORION TOREMIFENE CITRATE 03-JAN-96 (TABLET) ESPOO, FINLAND EQ 60MG BASE (NONSTEROIDAL ANTIESTROGEN) 20-552 COVERA-HS SEARLE VERAPAMIL HYDROCHLORIDE 17-JAN-96 (TABLET, SKOKIE, IL 180MG EXTENDED RELEASE) 60077...
