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,...
DDPA September 1995
50-685 CEDAX SCHERING PLOUGH CEFTIBUTEN DIHYDRATE 07-SEP-95 (CAPSULE) KENILWORTH, NJ EQ 400MG BASE 07033 (CEPHALOSPORIN) 50-686 CEDAX SCHERING PLOUGH CEFTIBUTEN DIHYDRATE 07-SEP-95 (POWDER, KENILWORTH, NJ EQ 90MG BASE/5ML FOR ORAL 07033 EQ 180MG BASE/5ML SUSPENSION) (CEPHALOSPORIN) 20-498 CASODEX ZENECA BICALUTAMIDE 14-SEP-95 (TABLET) WILMINGTON, DE 50MG 19850 (ANTIANDROGEN) [USE IN...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt
DIPIVEFRINE HCL IN MILAN, ITALY" 9277 06-Aug-91 PHARMECO LABS INC "DIPIVEFRIN MFG IN ARLESHEIM, SWITZERLAND" 9552 20-Feb-92 SUMIKA FINE CHEMICALS CO LTD "DIPIVEFRIN HYDROCHLORIDE MANUFACTURED IN GIGU-PREFECTURE AND OSAKA, JAPAN." 9564 06-Mar-92 "GILEAD SCIENCES, INC." "AMBISOME, LIPOSOMAL AMPHOTERICIN B MANUFACTURED IN SAN DIMAS, CALIFORNIA." 9572 03-Mar...
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls
IN BUDAPEST, HUNGARY PLANTEX LTD CHEM AND PHARM WORKS IMIPRAMINE HYDROCHLORIDE LUNDBECK PHARMACEUTICALS ITALY SPA IMIPRAMINE HYDROCHLORIDE AVENTIS PHARMA SA PROMETHAZINE HCL GRUPPO LEPETIT SPA D-PROPOXYPHENE HYDROCHLORIDE BULK SCHERING AG ETHINYL ESTRADIOL ROCHE COLORADO CORPORATION BISACODYL ROCHE DIAGNOSTICS GMBH DIGOXIN PRODUCTS SOLMAG S.P.A DICYCLOMINE ...
Comprehensive List of Current Guidance Documents at the Food and Drug Administration page 36
author: FDA
Annual Comprehensive List of Guidance Documents at the Food and Drug Administration page 32
author: FDA
subject: 7/21/2000
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...
http://www.fda.gov/cber/gdlns/guidelst.txt
Preliminary Guidance Implementation Plan USP injection October 2, 1995 Do Do nomenclature In Vivo Bioequivalence Studies of April 22, 1996 Do Do Clozapine Instructions for Filing Supplements April 11, 1996 Do Do Under the Provisions of SUPAC-IR Seventh of a series of letters about July 29, 1988 Do Do the Act providing guidance on the ``180-day exclusivity'' provision of section 505(j...
http://www.fda.gov/cber/gdlns/anguidlst.txt
Preliminary Guidance -------------------------------------------------------------------------------------------------------------------------------------------------------- Implementation Plan USP injection nomenclature October 2, 1995 Do Do -----------------------------------------------------------------------------------------------------------------------------------------------...
DDPA May 1995
20-147 TRAVASOL 2.75% - BAXTER AMINO ACIDS 09-MAY-95 SULFITE FREE - ROUND LAKE, IL 2.75% W/ELECTROLYTES 60073 DEXTROSE IN DEXTROSE 5% 5GM/100ML IN PLASTIC CONTAINER MAGNESIUM CHLORIDE (INJECTABLE) 51MG/100ML POTASSIUM PHOSPHATE, DIBASIC 261MG/100ML SODIUM ACETATE 216MG/100ML SODIUM CHLORIDE 112MG/100ML (FLUID, NUTRIENT AND ELECTROLYTE REPLENISHER) 20-147 TRAVASOL 2.75% - BAXTER AMINO...