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 Plus (initial 5 mixes plus Total IgE) 321-1 MultiAllergen Inhalant Test 321-2 MultiAllergen Inhalant Test with Total IgE 620 Regional Botanical Panel (21 to 44 allergens based on region) 620-1 Regional Botanical Panel with Total IgE 323-1 Aller-Food Panel (20 common food allergens) 304 Hymenoptera Profile (IgE) 304-1 Hymenoptera Profile (IgG4 Blocking Antibody) 322 Aller-Pac Plus...
author: Esoterix, Inc.
Esoterix, Inc. -- Test Menu Screen (A sensitive screen to identify atopic allergy using 5 mixes) see individual profiles ALLERGY PROFILES allergen listing ALLERGY TESTING see individual listings ALLERGY/IMMUNOLOGY 322-1 Aller-Pac Plus Panel with Foods (Inlcudes Regional Botanical Panel plus Total IgE, IgG, IgA, IgM and 5 common Food Allergens) 322 Aller-Pac Plus Panel (inlcudes Regional Botanical Panel plus...
author: Esoterix, Inc.
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,...
Aerogen News Evaluation of Three Small Volume Nebulizers for Use with Infant Ventilator Circuits scipres_aarc3_12-03.pdf 54kb - December 2003 Baby Don't Cry: In Vitro Comparison of "Baby's Breath" Aerosol Delivery Hood vs Face Mask or Blow-by Using the "SAINT" Infant Upper Airway Model and "Aeroneb Go" vs T-piece Nebulizer scipres_aarc2_12-03.pdf 1,314kb - December 2003 In Vivo Effect of Particle...
Aerogen News Evaluation of Three Small Volume Nebulizers for Use with Infant Ventilator Circuits scipres_aarc3_12-03.pdf 54kb - December 2003 Baby Don't Cry: In Vitro Comparison of "Baby's Breath" Aerosol Delivery Hood vs Face Mask or Blow-by Using the "SAINT" Infant Upper Airway Model and "Aeroneb Go" vs T-piece Nebulizer scipres_aarc2_12-03.pdf 1,314kb - December 2003 In Vivo Effect of Particle...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt "LINCOMYCIN HYDROCHLORIDE MANUFACTURED IN SUZHOU, CHINA" 13758 01-Sep-98 CIPAN SARL MINOCYCLINE HYDROCHLORIDE 13759 01-Sep-98 RANBAXY LAB LTD CEPHALEXIN 13760 01-Sep-98 "CHONGQING DAXIN PHARMACEUTICAL CO., LTD." "AMIKACIN BASE AS MANUFACTURED IN CHONGQING, CHINA" 13762 01-Sep-98 ACS DOBFAR AMIKACIN SULFATE 13763 01-Sep-98 ACS DOBFAR AMIKACIN SULFATE ...
Genzyme Tissue Repair Epicel should not be used in patients with a known history of anaphylaxis to vancomycin or amikacin amikacin Sulfate 1000 U/ ml Cefoperazone 100 µg/ ml Polymyxin B Sulfate & Bacitracin zinc 200 U/ ml, 10 U/ ml...
author: MIS
1997 New Drug Application (NDA) Approved Posted Aceon Capsules/Perindoppril Erbumine 2 mg, 4mg and 8 mg [940 KB] Rhone Poulenc Roher 020184/S003 1/8/1997 3/20/1998 Acephen G & W Labs 018060/S55 03/31/1997 9/11/2003 Acular PF/Ketorolac Tromethamine [5.5 MB] Hoffman-LaRoche 020811 11/3/1997 3/20/1998 Alesse Wyeth-Ayerst Laboratories 020683 3/27/1997 8/13/03 Allegra-D/Fenofenadine/pseudoephedrine Approval Letter,...
C:\Data\NDA\Capastat\03JuneApLetterS044.doc.doc NDA 50- 095/ S- 044 Page 3 2.01 PA 7954- A UCP CAPASTAT ® SULFATE CAPREOMYCIN FOR INJECTION, USP For Intramuscular and Intravenous Infusion Only Not for Pediatric Use WARNINGS The use of Capastat ® Sulfate (Capreomycin for Injection, USP) in patients with renal insufficiency or preexisting auditory impairment must be undertaken with great caution, and the risk...
author: Christine Lincoln
C:\Data\NDA\Capastat\03JuneApLetterS044.doc.doc page 1
author: Christine Lincoln
510(k)s Final Decisions Rendered for November 2002 FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH 510(k)s Final Decisions Rendered for November 2002 Some of the documents on this section of the CDRH Website are available only in PDF format and may not be accessible to those with certain disabilities
author: CDRH/ODE
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
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 APPENDIX E MAXIMUM DOSE AND ENDOTOXIN LIMIT TABLE April ,1992 Drug Name Acetic Acid Irrigation Acetazolamide Sodium Acetylcysteine Injection Acyclovir Sodium Adenosine Phosphate Albumin, Normal Human Serum (25%) Albumin, Normal Human Serum (20%) Albumin, Normal Human Serum (5%) Albuterol Sulfate Alcohol and Dextrose Injection Alfentanil Hydrochloride Alkaloids of Belladonna...
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 1
author: FDA / CBER
subject: December 1987 Guideline
http://www.invitrotech.com/filelib/QuickThaw.pdf Revised 22 January, 2002 Copyright © 2001: In Vitro Technologies, Inc., Baltimore, Maryland, USA Toll free: (888) 488- 3232 Fax: (410) 455- 1245 Email: info@ invitrotech. com Web: http:// www. invitrotech. com All rights reserved. 1 of 5 Storing and Thawing Cryopreserved Hepatocytes Introduction ...
http://www.invitrotech.com/filelib/QuickThaw.pdf page 1 Revised 22 January, 2002 Copyright © 2001: In Vitro Technologies, Inc., Baltimore, Maryland, USA Toll free: (888) 488- 3232 Fax: (410) 455- 1245 Email: info@ invitrotech. com Web: http:// www. invitrotech. com All rights reserved. 1 of 5 Storing and Thawing Cryopreserved Hepatocytes Introduction ...
Microsoft Word - PlatedHepInduction.doc Copyright © 2001: In Vitro Technologies, Inc., Baltimore, Maryland, USA Toll free: (888) 488- 3232 Fax: (410) 455- 1245 Web: http:// www. invitrotech. com Email: info@ invitrotech. com All rights reserved. 1 of 4 Revised: 05 March 2002 Cultured Hepatocyte Enzyme Induction Assay Introduction Freshly ...
Microsoft Word - PlatedHepInduction.doc page 1 Copyright © 2001: In Vitro Technologies, Inc., Baltimore, Maryland, USA Toll free: (888) 488- 3232 Fax: (410) 455- 1245 Web: http:// www. invitrotech. com Email: info@ invitrotech. com All rights reserved. 1 of 4 Revised: 05 March 2002 Cultured Hepatocyte Enzyme Induction Assay Introduction Freshly ...
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...
Drug Approvals for April 1997 Drug Approvals for April 1997 Definitions and Notes April 1997 Original New Drug Applications Original Application #: 020619 Approval Date: 17-APR-97 Trade Name: BETOPTIC PILO Chemical Type: 4 Therapeutic Potential: S Dosage Form: SUSPENSION/DROPS Applicant: ALCON LABORATORIES INC Active Ingredient(s): BETAXOLOL HYDROCHLORIDE; PILOCARPINE HYDROCHLORIDE OTC/RX Status: RX Indication(s)...
DDPA December 1995 20-545 PROCANBID PARKE DAVIS PROCAINAMIDE HYDROCHLORIDE 14-DEC-95 (TABLET, ANN ARBOR, MI 500MG EXTENDED RELEASE) 48106 1000MG (ANTIARRHYTHMIC) 20-518 RETROVIR GLAXO WELLCOME ZIDOVUDINE 19-DEC-95 (TABLET) RES TRIANGLE PK, NC 300MG 27709 (ANTIVIRAL) 20-535 BROMFENAC SODIUM WYETH AYERST BROMFENAC SODIUM 28-DEC-95 (CAPSULE) RADNOR, PA EQ 25MG BASE 19087 EQ 50MG BASE (NONSTEROIDAL ANTI...
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)...
ssm 1454B-8x10-75.qxd Trigger Process Identified T1: Diphenhydramine T2: Vitamin K T3: Flumazenil T4: Droperidol T5: Naloxone T6: Antidiarrheals T7: Sodium polystyrene T8: PTT >100 seconds T9: INR >6 T10: WBC <3000 × 106/ µL T11: Serum glucose <50 mg/ dL T12: Rising serum creatinine T13: Clostridium difficile positive stool T14: Digoxin level >2 ng/ mL T15: Lidocaine level >5 ng/ mL T16:...
author: gbon
