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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,...
material_safety_data_sheet_letter_new_.doc ® (Fluorometholone, Ophthalmic Ointment) 0.1% ALBALON® (Naphazoline HCl Ophthalmic Solution) 0.1% FML- S® (Fluorometholone, Sulfacetamide Sodium Ophthalmic Suspension) ALLERGAN® Eye Wash Gentamicin Sulfate, 0.3% ALOCRILO (Nedocromil Sodium Ophthalmic Solution 2%) HYLAFORM® (Hylan B Gel) BLEPH- 10® (Sulfacetamide Sodium Ophthalmic Solution) 10...
author: hutton_ronald
material_safety_data_sheet_letter_new_.doc page 2
author: hutton_ronald
Acumedia Ordering A B C D E F G H K L M - N O P R S T U V W X Y - - Product # and Units Acumedia Product Description 7178A 500 g 7178B 2 kg 7178C 10 kg Agar, Bacteriological Solidifying agent for use in preparing microbiological culture media 7302A 500 g 7302B 2 kg 7302C 10 kg APT Agar For the cultivation of heterofermentative lactobacilli 7315A 500 g 7315B 2 kg 7315C 10 kg Azide Dextrose Broth...
What's new at CDER by Date - U.SB
author: Paul Stauffer
Drug Approvals - M NDA 13-422/S-035 4/17/03 - - - Maxipime (Cefepime Hydrochloride) Injection,-Rx Bristol-Myers Squibb NDA 50-679/S-21 3/17/03 3/26/03 3/26/03 Maxipime (Cefepime Hydrochloride) Injection,- Bristol-Myers Squibb NDA 50-679/S-009, S-014 and S-018 8/21/02 8/26/02 - Maxipime (Cefepime Hydrochloride) Injection Bristol-Myers Squibb NDA 50-679/S007 1/27/99 - - 7/18/01 Maxitrol (neomycin and ...
Drug Approvals - B Product Name Company Application # Approval Date Letter Posted Label Posted Review Posted Bacitracin Injection, 50,000 units/vial, Rx American Pharmaceutical Partners ANDA 65-116 12/3/02 - - - Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment USP, Rx Altana, Inc
Drug Approvals - N Product Name Company Application # Approval Date Letter Posted Label Posted Review Posted Nabumetone Tablets, 500 mg, Rx- Second (Tentative Approval) Copley Pharmaceutical, Inc
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt API DIVISION" "AMOXICILLIN MFG IN MEXICO, MISSOURI" 13520 01-Sep-98 ANTIBIOTICOS TETRACYCLINE PHOSPHATE COMPLEX 13521 01-Sep-98 KYOWA HAKKO MITOMYCIN 13523 01-Sep-98 GIST BROCADES (IT) NYSTATIN 13527 01-Sep-98 BRISTOL MYERS SQUIBB INDUSTRIAL DIV AMIKACIN SULFATE 13535 01-Sep-98 MEIJI SEIKA KAISHA L PENICILLIN G PROCAINE 13536 01-Sep-98 ALPHARMA APS POLYMYXIN B ...
Genzyme Tissue Repair Agent Maximum Dose* Agent Maximum Dose* Amphotericin B 24 µg/ ml Polymyxin B Sulfate 1000 U/ ml Cefoperazone 100 µg/ ml Polymyxin B Sulfate & Bacitracin zinc 200 U/ ml, 10 U/ ml Ciprofloxacin 5 µg/ ml Polymyxin B Sulfate, Bacitracin zinc and Neomycin Sulfate 100 U/ ml, 25 U/ ml, 0.6 mg/ ml Gentamicin ...
author: MIS
Genzyme Tissue Repair page 5
author: MIS
Prescription and Over-the-Counter Drug Product List: 10/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN >A> AA VINTAGE PHARMS 500MG/15ML;7.5MG/15ML N40520 001 OCT 30, 2003 OCT NEWA TABLET; ORAL ANEXSIA >D> AA MALLINCKRODT 750MG;10MG N40468 001 OCT 31, 2002 OCT CTNA >A> AA 750MG;10MG N40468 001 OCT 31, 2002 OCT CTNA ALBUTEROL SULFATE ...
ANDA Approvals February 2002 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - February 2002 - ANDA Number Drug Name Applicant Approval Date 1 75-810 FLUOXETINE HYDROCHLORIDE TABLETS 10 MG (BASE) BARR LABORATORIES, INC
author: USERNAME
Prescription and Over-the-Counter Drug Product List: 2/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL -A- CODRIX -A- + ANDRX PHARMS 500MG;15MG N40447 001 FEB 26, 2003 FEB NEWA AZATHIOPRINE TABLET; ORAL AZASAN -A- AAIPHARMA LLC 25MG N75252 002 FEB 03, 2003 FEB NEWA -A- AB 50MG N75252 001 JUN 07, 1999 FEB NEWA -A- 75MG N75252 003 FEB 03, 2003 FEB NEWA -A- 100MG N75252 004 FEB 03, 2003...
author: AUTHOR
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 OfficeSulfate) Tablets SmithKline & French Laboratories 83-900 2/26/1976 12/17/2001 Benztropine Mesylate Tablets [10.9 MB] Rosemont Pharmaceutical Corp
FDA Drug Approvals List February 2002 Active Ingredient(s): BUSPIRONE HYDROCHLORIDE OTC/RX Status: RX Original Abbreviated Antibiotic Application#065022 Approval Date: 27-FEB-02 Trade Name: BACITRACIN ZINC AND POLYMYXIN B SULFATE Dosage Form: OINTMENT Applicant: ALTANA INC Active Ingredient(s): BACITRACIN ZINC; POLYMYXIN B SULFATE OTC/RX Status: RX Original Abbreviated Application#...
Prescription and OTC Drug Product List 11/2001 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET; ORAL PERCOCET -A- + ENDO PHARMS 325MG;7.5MG N40434 001 NOV 23, 2001 NOV NEWA -A- + 325MG;10MG N40434 002 NOV 23, 2001 NOV NEWA ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE -A- AB ANABOLIC 325MG;50MG;40MG;30MG...
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...
Prescription and OTC Drug Product List 6/2002 -D- + WYETH AYERST 20,000 UNITS/VIAL N17055 003 JUN DISC -A- @ 20,000 UNITS/VIAL N17055 003 JUN DISC CHORIONIC GONADOTROPIN -D- + STERIS 2,000 UNITS/VIAL N17016 011 FEB 16, 1990 JUN DISC -A- @ 2,000 UNITS/VIAL N17016 011 FEB 16, 1990 JUN DISC GRANISETRON HYDROCHLORID E SOLUTION; ORAL KYTRIL -D- + ROCHE EQ 2MG BASE/10ML N21238 001 JUN 27, 2001 JUN DISC -A- @ EQ 2MG BASE/10ML N21238...
Prescription and OTC Drug Product List 2/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST AMOXICILLIN; CLAVULANATE POTASSIUM FOR SUSPENSION; ORAL AUGMENTIN '400' -D- + GLAXOSMITHKLINE 400MG/5ML;EQ 57MG BASE/5ML N50725 002 MAY 31, 1996 FEB CRLD -A- 400MG/5ML;EQ 57MG BASE/5ML N50725 002 MAY 31, 1996 FEB CRLD AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ...
http://www.fda.gov/cdrh/pdf2/k022584.pdf page 1
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 OO units Pentagastrin 0.006 mg Pentamidine Isethionate 4.00 mg Pentobarbital Sodium Injection 6.00 mg Pentazocine Lactate Injection 0.86 mg Perphenazine 0.14 mg Phenobarbital Sodium Injection 20.00 mg Phenolsulfonphthalein 0.09 mg Phentolamine Mesylate 0.86 mg Pentylenetetrazol 7.14 mg Phenylephrine HCI 0.20 mg Phenytoin Sodium Injection 20.00 mg Physostigmine Salicylate 0.06 mg...
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 5
author: FDA / CBER
subject: December 1987 Guideline
Prescription and OTC Drug Product List 12/1998 Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 12: December 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST - ADD - ABACAVIR SULFATE ALBUTEROL SULFATE - ADD - SOLUTION; ORAL SOLUTION; INHALATION - ADD - ZIAGEN ALBUTEROL SULFATE - ADD - + GLAXO WELLCOME EQ 20MG BASE/ML N20978 001 -...
