http://www.fda.gov/cder/orange/appendix_a.txt 4, ACETAMINOPHEN PHENAPHEN-650 W/ CODEINE, ACETAMINOPHEN PHENAZINE, PHENDIMETRAZINE TARTRATE PHENAZINE-35, PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE PHENERGAN FORTIS, PROMETHAZINE HYDROCHLORIDE PHENERGAN PLAIN, PROMETHAZINE HYDROCHLORIDE PHENERGAN VC W/ CODEINE, CODEINE PHOSPHATE PHENERGAN VC, PHENYLEPHRINE HYDROCHLORIDE PHENERGAN W/ CODEINE, CODEINE...
Quinidine, Serum Quinidine, Serum ---- Number 007831 CPT 80194 Synonyms Cardioquin®; Duraquin®; Quinaglute®; Quinidex®; Quinora ® Specimen Serum or plasma Volume 1 mL Minimum Volume 0.3 mL Container Red-stopper tube or green-stopper (heparinized plasma) tube.
NUMERICAL INDEX NUMERICAL INDEX 000455 see Thyroid Panel 000620 see Thyroid Panel With TSH 000679 see Hemoglobinopathy Profile 000703 see Renin Activity and Aldosterone 000810 see Vitamin B12 and Folates 001016 see Calcium, Serum 001024 see Phosphorus, Serum 001032 see Glucose, Serum 001040 see Urea Nitrogen, Serum 001057 see Uric Acid, Serum 001065 see Cholesterol, Total 001073 see Protein, Total,...
Esoterix, Inc. -- Test Menu vivax) 300523 Platelet Antibody, Direct 300521 Platelet Antibody Drug-Induced *** 300520 Platelet Antibody Screen, Indirect (HLA, Platelet Glycoprotein) 500679 Platelet Count 300504 Platelet Factor 4 300805 Platelet Neutralization Procedure 300524 Platelet Specific Antibody (GP IIb/IIIa) 300526 Platelet Specific Antigen PLA1 (HPA-1a) 300531 Platelet Specific Antigen-2 (PLA2)...
author: Esoterix, Inc.
CDER Guidance Documents (Issued 8/2000, Posted 8/8/2000) Joint Safety/Efficacy (Multidisciplinary) (Draft) Submitting Marketing Applications According to the ICH/CTD Format: General Considerations (Issued 9/2001, Posted 9/5/2001) [ PDF ] M4 Common Technical Document--Quality: Questions and Answers/Location Issues [ HTML ] or [ PDF ] or [ ] (Issued 9/12/2002, Posted 12/30/2002) Quality Q1E Evaluation of...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt FACILS & CONTROLS FOR MANUFACTURE OF L-PROLINE IN REXIM PLANT 3672 26-Dec-79 BAYER NIFEDIPINE 3675 07-Dec-79 UNIQUE CHEMICALS METRONIDAZOLE 3677 20-Dec-79 BUCHLER AND CO "QUINIDINE SULFATE,QUINIDINE BASE AND QUINIDINE GLUCONATE" 3689 16-Jan-80 UCB PHARMACEUTICALS INC MECLIZINE HCL 3695 16-Jan-80 UCB PHARMACEUTICALS INC HYDROXYZINE PAMOATE 3699 18-Jan-80 ROCHE DIAGNOSTICS...
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls AMIODARONE HCL BAXTER ONCOLOGY GMBH IFOSFAMIDE GEDEON RICHTER LTD VINCRISTINE SULFATE FABBRICA ITALIANI SINTETICI SPA FUROSEMIDE DINAMITE DIPHARMA SPA TRIAMTERENE USP XIX/BP '73 DINAMITE DIPHARMA SPA CYPROHEPTADINE HCL, USP AVENTIS PHARMA SA PREDNISOLONE ACETATE NISSHIN FLOUR MILLING CO., LTD
V:\DAVDP\CSO\BEHR\NDA\Crimson\20685crix\SLR\slr058\dfsdocpippil\ tr.doc CRIXIVAN ® (INDINAVIR SULFATE) CAPSULES DESCRIPTION CRIXIVAN * (indinavir sulfate) is an inhibitor of the human immunodeficiency virus (HIV) protease
author: Virginia Behr
http://www.paddocklabs.com/images/PadSec7-1.pdf page 5
Prescription and Over-the-Counter Drug Product List: 6/2003 >D> AP + WYETH AYERST 5,000 UNITS/VIAL N17055 001 JUN DISC >A> @ 5,000 UNITS/VIAL N17055 001 JUN DISC >D> AP + 10,000 UNITS/VIAL N17055 002 JUN DISC >A> @ 10,000 UNITS/VIAL N17055 002 JUN DISC GUANABENZ ACETATE TABLET; ORAL GUANABENZ ACETATE >D> AB WATSON LABS EQ 8MG BASE N74025 002 FEB 28, 1994 JUN CRLD >A> AB + EQ 8MG BASE N74025 002 FEB 28, 1994 JUN CRLD >D> WYTENSIN >D> AB WYETH...
author: AUTHOR
Prescription and Over-the-Counter Drug Product List: 5/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, APAP, AND CAFFEINE -A- AB AXIOM PHARM 325MG;50MG;40MG N89536 001 FEB 16, 1988 MAY CAHN -D- AB HALSEY 325MG;50MG;40MG N89536 001 FEB 16, 1988 MAY CAHN ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -A- AA ABLE 500MG;7.5MG...
author: AUTHOR
Prescription and Over-the-Counter Drug Product List: 4/2003 45 -D- XCEL PHARMS 1MG/ML N05929 001 APR CFTG -A- AP + 1MG/ML N05929 001 APR CFTG -A- DIHYDROEROGTAMINE MESYLATE -A- AP PADDOCK 1MG/ML N40475 001 APR 28, 2003 APR NEWA DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE; ORAL -A- TAZTIA XT -A- AB4 ANDRX PHARMS 120MG N75401 001 APR 10, 2003 APR NEWA -A- AB4 180MG N75401 002 APR 10, 2003 APR NEWA -A- AB4 240MG N75401 003 APR 10, 2003 APR...
author: AUTHOR
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
Prescription and Over-the-Counter Drug Product List: 3/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL FIORICET W/ CODEINE -D- AB + NOVARTIS 325MG;50MG;40MG;30MG N20232 001 JUL 30, 1992 MAR CAHN -A- AB + WATSON PHARMS 325MG;50MG;40MG;30MG N20232 001 JUL 30, 1992 MAR CAHN ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL CODRIX -A- + ANDRX PHARMS 500MG;30MG N40441 001...
author: AUTHOR
FDA Drug Approvals List August 2001 JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE Active Ingredient(s): COPPER OTC/RX Status: RX Application #:018612 Labeling Supplement#: 026 To Original New Drug Application Approval Date: 24-AUG-01 Trade Name: NICORETTE Dosage Form: GUM, CHEWING Applicant: SMITHKLINE BEECHAM CONSUMER HEALTHCARE LP Active Ingredient(s): NICOTINE POLACRILEX OTC/RX Status: RX Application #: 014879 Labeling...
Prescription and OTC Drug Product List 12/2001 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE CAPSULE; ORAL SYNALGOS-DC-A -A- @ WOMEN FIRST HLTHCARE 356.4MG;30MG;16MG N89166 001 MAY 14, 1986 DEC CAHN -D- @ WYETH AYERST 356.4MG;30MG;16MG N89166 001 MAY 14, 1986 DEC CAHN ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL ANEXSIA 5/325 -D- AA MALLINCKRODT 325MG;5MG N40409...
http://www.merck.com/product/usa/pi_circulars/c/crixivan/crixivan_pi.pdf 1 7979825 CRIXIVAN ® (INDINAVIR SULFATE) CAPSULES DESCRIPTION CRIXIVAN * (indinavir sulfate) is an inhibitor of the human immunodeficiency virus (HIV) protease
V:\DAVDP\CSO\YOERG\NDA\Crimson\20685crix\SLR\slr057\dfscopylett\ er.doc 4 7979825 CRIXIVAN ® (INDINAVIR SULFATE) CAPSULES DESCRIPTION CRIXIVAN * (indinavir sulfate) is an inhibitor of the human immunodeficiency virus (HIV) protease
author: Virginia Yoerg
Specific List for Categorization of Laboratory Test Systems, Assays, and Examinations by Complexity; Notice FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH - CLIA Related Federal Register - [Federal Register: May 15, 1995 (Volume 60, Number 93)] [Notices ] [Page 25943-25976] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr15my95-101] [[Page 25943]] _______________________________________________________________________ Part II...
author: CLIA
Notice of Specific List for Categorization of Laboratory Test Systems, Assays, and Examinations by Complexity. FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH CLIA Related Federal Register [Federal Register: April 11, 1997 (Volume 62, Number 70)] [Notices] [Page 17832-17849] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr11ap97-96] ======================================================================= -----------------------------------...
author: CLIA
withdrawn.PDF page 2
author: walshju
http://www.fda.gov/cder/foi/label/2001/20685s41lbl.pdf 1 CRIXIVAN ® (INDINAVIR SULFATE) CAPSULES DESCRIPTION CRIXIVAN * (indinavir sulfate) is an inhibitor of the human immunodeficiency virus (HIV) protease
CDER Guidance Documents (Issued 8/2000, Posted 8/8/2000) Joint Safety/Efficacy (Multidisciplinary) (Draft) M2 Electronic Common Technical Document Specification [ HTML ] or [ PDF ] (Issued 6/2002, Posted 6/13/2002) Submitting Marketing Applications According to the ICH/CTD Format: General Considerations (Issued 9/2001, Posted 9/5/2001) [ PDF ] M4 Common Technical Document--Quality: Questions and Answers...
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 12.00 mg 14.30 mg 0.28 mg 1.43 mg 2.80 mg 1.00 mg 0.43 mg 1.10 mg Propoxycaine, Procaine HCI & Levonordefrin 6.60 mg Propoxycaine, Procaine HCI & Norepinephrine Bitartrate 6.60 mg 49 0.50 100.00 # 4.55 0.003 0.03/ 100 units 17.00 + 8.80 + 8.80 + 0.50 + 1.10 + 0.50 0.50 0.10 + 31.25 4.39 5.00 5.80 + 8.80 + 0.90 + 0.90 + 0.60 + 0.60 + 0.60 + 0.60 + 0.42 0.35 + 17.90 + 3.50 1.80 + 5.00 ...
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 6
author: FDA / CBER
subject: December 1987 Guideline
