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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
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material_safety_data_sheet_letter_new_.doc page 2
author: hutton_ronald
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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...
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H: 06AP.PDF
ANDA 65- 006 December 17, 1998 Taylor Pharmaceuticals Attention: James G
1222 West Grand Avenue Decatur, IL 62525- 1220 Dear Sir: This is in reference to your abbreviated new drug application dated January 20, 1998, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act, for Trimethoprim Sulfate and Polymyxin B Sulfate...
author: Unknown
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H: 06AP.PDF page 1
author: Unknown
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Conjunctivitis: Conjunctival and Scleral Disorders: 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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http://www.fda.gov/cder/foi/label/2000/50567s16lbl.pdf
POLYTRIM® OPHTHALMIC SOLUTION (trimethoprim sulfate and polymixin B sulfate ophthalmic solution) DESCRIPTION POLYTRIM® (trimethoprim sulfate and polymyxin B sulfate ophthalmic solution) is a sterile antimicrobial solution for topical ophthalmic use
Microbiology: In vitro studies have demonstrated that the anti- infective...
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http://www.fda.gov/cder/foi/label/2000/50567s16lbl.pdf page 3
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http://www.fda.gov/cder/foi/label/2000/50567s16lbl.pdf page 2
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http://www.fda.gov/cder/foi/label/2000/50567s16lbl.pdf page 1
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http://www.fda.gov/cder/foi/appletter/2000/50567s16ltr.pdf page 1
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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
ANDA 65-022 2/27/02 - - - Baclofen Injection, 0.05mg/ml, Rx Medtronic Neurological NDA 20...
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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 ...
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1997 Abbreviated New Drug Applications (Generic Drugs)
74579 11/26/97 4/7/99 Bleomycin Sulfate - Pharmacia 064084 06/03/1996 8/4/2003 Brompheniramine Chromalloy Pharmaceuticals 085888 04/26/1978 8/6/2003 Bumetanide Injection USP, 0.25 mg/mL
74808 7/8/97 4/9/99 Prednicen-M The Central Pharmacal 084655 12/09/1975 8/6/2003 Prelone Muro Pharmaceutical 089081 02/04/1986 8/6/2003 Proben-C Chelsea Laboratories 085552 09/15/1977 8/6...
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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...
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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
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
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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 -...
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Prescription and OTC Drug Product List 8/1998
Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 8: August 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE TABLET; ORAL TABLET; ORAL - ADD - BUTALBITAL, ACETAMINOPHEN AND CAFFEINE MODURETIC 5-50 - ADD - AB MALLINCKRODT...
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Prescription and OTC Drug Product List 7/1998
Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 7: July 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE - ADD - CALFACTANT TABLET; ORAL - ADD - INJECTABLE; INJECTION BUTALBITAL,ACETAMINOPHEN AND CAFFEINE - ADD - INFASURF PRESERVATIVE FREE - ADD - AB + MIKART 500MG...
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Prescription and OTC Drug Product List 3/1999
Prescription and Over-the-Counter Drug Product List - 19th Edition Cumulative Supplement Number 3: March 1999 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE CALCIUM CHLORIDE; DEXTROSE; GLUTATHIONE DISULFIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CAPSULE; ORAL CHLORIDE; SODIUM PHOSPHATE...
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Prescription and OTC Drug Product List 1/2000
Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 1: January 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST PRESCRIPTION DRUG PRODUCT LIST 1 20TH EDITION ADDITIONS/DELETIONS FOR RX DRUG PRODUCT LIST / CUMULATIVE SUPPLEMENT NUMBER 1 / JAN'2000 - ADD - CALCIUM CHLORIDE CEFTIBUTEN DIHYDRATE - ADD -...
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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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Prescription and OTC Drug Product List 2/2001
PEDIATRIC - ADD - @ 10MG;100MG N74080 001 - ADD - + ASTRAZENECA /1VIL;0.02MG/VIAL;0.001MG/VIAL; - ADD - MAR 25, 1994 - ADD - 5MG/VIAL;0.01MG/VIAL;0.14MG/VIAL; - ADD - @ 25MG;100MG N74080 002 - ADD - 17MG/VIAL;0.2MG/VIAL; - ADD - MAR 25, 1994 - ADD - EQ 1MG BASE/VIAL;1.4MG/VIAL; - ADD - @ 25MG;250MG N74080 003 - ADD - EQ 1.2MG BASE/VIAL;0.7MG/VIAL; - ADD - MAR 25, 1994 - ADD - 7MG...
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FDA Drug Approvals List- April 1998
Application #: 020555 Efficacy Supplement#: 003 Type: SE1 to Original New Drug Application Approval Date: 01-APR-98 Trade Name: AXID AR Dosage Form: TABLET Applicant: WHITEHALL ROBINS HEALTHCARE Active Ingredient(s): NIZATIDINE OTC/RX Status: OTC Efficacy Claim: Provides for treatment of episodic heartburn, acid indigestion and sour stomach Application #: 020393 Efficacy Supplement#:...
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February Drug Approvals
Drug Approvals for February 1997 Definitions and Notes February 1997 Original New Drug Applications Original Application #: 020723 Approval Date: 27-FEB-97 Trade Name: ALDARA Chemical Type: 1 Therapeutic Potential: S Dosage Form: CREAM Applicant: 3M PHARMACEUTICALS INC Active Ingredient(s): IMIQUIMOD OTC/RX Status: RX Indication(s): Treatment of external genital and perianal warts...
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