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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,...
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http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt
LISINOPRIL CRUDE AS MFG IN COURBEVOIE AND HAM FRANCE 14537 19-Nov-99 FUJISAWA PHARMACEUTICAL CO LTD FK8453 DRUG SUBSTANCE AS MFG IN HYOGO AND OSAKA JAPAN 14538 09-Nov-99 SICOR DE MEXICO SA DE CV AMCINONIDE AS MFG IN LERMA MEXICO 14539 18-Nov-99 "UQUIFA ITALIA, S.P.A." CLINDAMYCIN HYDROCHLORIDE USP AS MFG IN MILAN ITALY 14540 18-Nov-99 DIOSYNTH BV TESTOSTERONE UNDECANOATE AS MFG IN...
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http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls
DIHYDROERGOTOXINE METHANESULFONATE (ERGOLOID MESYLATES) IVAX-CR A.S
PHYTONADIONE, USP (VITAMIN K1) MANUFACTURED IN TOKYO, JAPAN AVENTIS PHARMA SA PREDNISOLONE USP MANUFACTURED IN PUTEAUX, FRANCE MAKOR CHEMICALS LTD DACTINOMYCIN CHUGAI PHARMACEUTICAL CO LTD SUCRALFATE CARAFATE TM GANES CHEMICALS INC PROPOXYPHENE NAPSYLATE, BULK FORM-MANUF CARLSTADT, NJ FACILITY...
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http://www.fda.gov/cder/ogd/rld/RLD_LABELING_APPROVED_NOV_1998.HTML
Firm Date PHENDIMETRAZINE TARTRATE CAPSULE Phendimetrazine Tartrate Capsule 18-074 S-028 Eon 3-Nov-1998 BUTISOL SODIUM Butabarbital Sodium Tablet 00-793 S-015 Wallace 4-Nov-1998 HYDRODIURIL Hydrochlorothiazide Tablet 11-835 S-060 Merck 5-Nov-1998 ATROVENT MDI Ipratropium Bromide 20-394 S-001 Boehringer-Ingelheim 9-Nov-1998 PEPCID AC Famotidine Tablet 20-325 ...
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Prescription and OTC Drug Product List 6/2002
45 -D- + NOVARTIS 1MG/ML N05929 001 JUN CAHN -A- XCEL PHARMS 1MG/ML N05929 001 JUN CAHN DILTIAZEM HYDROCHLORIDE INJECTABLE; INJECTION CARDIZEM -D- AP + AVENTIS PHARMS 5MG/ML N20027 001 OCT 24, 1991 JUN CAHN -D- + 25MG/VIAL N20027 003 AUG 18, 1995 JUN CAHN -A- AP + BIOVAIL 5MG/ML N20027 001 OCT 24, 1991 JUN CAHN -A- + 25MG/VIAL N20027 003 AUG 18, 1995 JUN CAHN DILTIAZEM MALATE;...
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FDA Drug Approvals List- November 1998
Drug Approvals for November 1998 Definitions and Notes November 1998 Original New Drug Applications Original Application #: 021008 Approval Date: 25-NOV-98 Trade Name: SANDOSTATIN LAR Chemical Type: 3 Therapeutic Potential: P Dosage Form: INJECTABLE Applicant: NOVARTIS PHARMACEUTICALS CORP DBA SANDOZ PHARMACEUTICALS CORP Active Ingredient(s): OCTREOTIDE ACETATE OTC/RX Status: RX...
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Prescription and OTC Drug Product List 7/2001
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, ACETAMINOPHEN AND CAFFEINE -A- AB ABLE 325MG;50MG;40MG N40390 001 JUL 23, 2001 JUL NEWA -A- AB 500MG;50MG;40MG N40394 001 JUL 23, 2001 JUL NEWA ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -D- AA + WATSON LABS 325MG;7.5MG...
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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
Conc.( equine) 3.00 mL Dipyridamole 0.14 mg Dobutamine HCI 0.90 mg 5.00 1.10 2.17 3.57 1.80 1.80 1.80 1.80 45.45 5.00 1.25 5.56 11.60 + 0.50 + 35.70 + 71.43 16.70 + 17.20 + 0.70 + 0.70 + 111.00 + 200.00 + 1.00 357.00 0.003 + 0.50 + 166.67 1.00 4.00 0.50 + 1.00 8.77 3.40 + 16.67 1.67 37.70 5.56 40 Dopamine HCI Dopamine HCl in Dextrose Doxapram HCI Injection Doxorubicin HCI for...
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 7
author: FDA / CBER
subject: December 1987 Guideline
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Comprehensive List of Current Guidance Documents at the Food and Drug Administration page 36
author: FDA
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Annual Comprehensive List of Guidance Documents at the Food and Drug Administration page 32
author: FDA
subject: 7/21/2000
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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...
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http://www.fda.gov/cber/gdlns/anguidlst.txt
Preliminary Guidance -------------------------------------------------------------------------------------------------------------------------------------------------------- Implementation Plan USP injection nomenclature October 2, 1995 Do Do -----------------------------------------------------------------------------------------------------------------------------------------------...
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Dementia: Delirium and Dementia: Merck Manual Home Edition
Search Recent Searches Index Sections A B C D E F G H I J K L M N O P Q R S T U V W X Y Z Accidents and Injuries Blood Disorders Bone, Joint, and Muscle Disorders Brain, Spinal Cord, and Nerve Disorders Cancer Children's Health Issues Digestive Disorders Disorders of Nutrition and Metabolism Drugs Ear, Nose, and Throat Disorders Eye Disorders Fundamentals Heart and Blood Vessel...
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