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http://www.fda.gov/cder/orange/appendix_a.txt
APPENDIX A PRODUCT NAME INDEX ** 0 ** 0, AMOXICILLIN ** 8 ** 8-HOUR BAYER, ASPIRIN (OTC) 8-MOP, METHOXSALEN ** A ** A-HYDROCORT, HYDROCORTISONE SODIUM SUCCINATE A-METHAPRED, METHYLPREDNISOLONE SODIUM SUCCINATE A-N STANNOUS AGGREGATED ALBUMIN, TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT A-POXIDE, CHLORDIAZEPOXIDE HYDROCHLORIDE A.P.L., GONADOTROPIN, CHORIONIC A/T/S...

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http://www.fda.gov/cder/da/ddpa91.wpd
19 531 NUTRILI 10% MCGAW SOYBEAN OIL 02 08 91 (INJECTABLE) IRVINE, CA 10% 92713 (NUTRIENT REPLENISHER) 19 531 NUTRILI 20% MCGAW SOYBEAN OIL 02 08 91 (INJECTABLE) IRVINE, CA 20% 92713 (NUTRIENT REPLENISHER) 20-069 DIANEAL PD-2 BAXTER CALCIUM CHLORIDE 02-19-91 ELECTROLYTE ROUND LAKE, IL 514MG/100ML CONCENTRATE 60073 MAGNESIUM CHLORIDE IN PLASTIC CONTAINER 102MG/100ML (SOLUTION) SODIUM...

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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...

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http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls
AVENTIS PHARMA SA HYDROCORTISONE HEMISUCCINATE ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV ERTHROMYCIN PHOSPHATE ORGAMOL SA BUPIVACAINE HCL AVENTIS PHARMA SA 6-ALPHA-METHYLPREDNISOLONE HEMISUCCINATE PROCOS SPA PHENYLTOLOXAMINE CITRATE PROCOS SPA ORPHENADRINE HYROCHLORIDE & ORPHENADRINE CITRATE BASF CORP POVIDONE-IODINE LEK PHARMACEUTICALS D.D
URSODEOXYCHOLIC ACID...

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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, 2001...
author: AUTHOR
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1997 Abbreviated New Drug Applications (Generic Drugs)
Generic Drug Approval Packages These drug approval packages, sorted by product trade name, are supplied by the CDER Freedom of Electronic Information Office
074946 11/19/1997 3/30/1998 Adriamycin PFS (Doxorubicin Hydrochloride) Injection ,- Adria Laboratories 63165/S3, S5, S6 7/9/1993 8/8/2002 Albuterol Inhalation Aerolsol, 90 mcg/Actuation
64155, 64164, 64165, 64166 10/2/1997...
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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
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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
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Comprehensive List of Current Guidance Documents at the Food and Drug Administration page 29


author: FDA
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Prescription and OTC Drug Product List 5/2001
Prescription and Over-the-Counter Drug Product List - 21st Edition Cumulative Supplement Number 5: January-May 2001 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATE - ADD - ALMOTRIPTAN MALATE CAPSULE; ORAL - ADD - TABLET; ORAL ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE - ADD - AXERT - DLT - + MIKART 150MG;180MG...
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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...

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