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http://www.fda.gov/cder/orange/appendix_a.txt
45, DIHYDROERGOTAMINE MESYLATE DACARBAZINE, DACARBAZINE DALGAN, DEZOCINE DALMANE, FLURAZEPAM HYDROCHLORIDE DANAZOL, DANAZOL DANOCRINE, DANAZOL DANTRIUM, DANTROLENE SODIUM DAPSONE, DAPSONE DARANIDE, DICHLORPHENAMIDE DARAPRIM, PYRIMETHAMINE DARBID, ISOPROPAMIDE IODIDE DARICON, OXYPHENCYCLIMINE HYDROCHLORIDE DARVOCET A500, ACETAMINOPHEN DARVOCET, ACETAMINOPHEN DARVOCET-N 100,...

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http://www.fda.gov/cder/foi/label/2001/18155s22lbl.pdf
OPTlCROM (cromol n sodium ophthalmic solution, USP) 4% Sterile D SCRIPTION OPTICROM ( cro olyn sodiu ic solution, USP) 4% is a clear, colorless, sterile solution intended or topical ophthal ic use
Mast cell stabilizer Each L contains: Active: Cro olyn sodiu g ( 4%); Preservative: Benzalkoniu chloride 0.01%; Inactives: Edetate disodiu 1% and puri ied water
Another study...

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uhn3365.tmp
Ionamidol/ ml 41% 61% 76% (- 2oo) y%& [- 370) Iopamidol (mg) 408 612 755 408 612 m Tromethamine (mg) Edetate Ca Naz( mg) Water for Injection Both formulations are adjusted, if needed, to pH 6.5 7.5 with HC1
Iopamidol Tromethamine Edetate Calcium Disodium Water for Injection Hydrochloric Acid (pH adjustment) Route of Administration: Intravascular Dosage Form: Injectable...

author: fda
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Bioniche
February 12, 2008 Bioniche Reports Fiscal 2008 Second Quarter February 8, 2008 Bioniche Receives $5 Million Capital Financing Support to Scale-up E.
coli O157:H7 Vaccine Production Check latest stock price All prices delayed at least 15 minutes.
News Release Bioniche Receives FDA Approval for EDTA Injection 17/07/02 BELLEVILLE, Ontario, July 17, 2002 - Bioniche Life Sciences...
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Bioniche
February 12, 2008 Bioniche Reports Fiscal 2008 Second Quarter February 8, 2008 Bioniche Receives $5 Million Capital Financing Support to Scale-up E.
a€œWe continued building on fundamentals, concentrating on revenue growth and maximizing income before research.
Delivering a recurring cash flow break even or positive position is one of Management's key objectives over...
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Elestat PI 8.5x11.qxd
ELESTAT ® (epinastine HCI ophthalmic solution) 0.05% Sterile DESCRIPTION ELESTAT ® (epinastine HCl ophthalmic solution) 0.05% is a clear, colorless, sterile isotonic solution containing epinastine HCl, an antihistamine and an inhibitor of histamine release from the mast cell for topical administration to the eyes.
285.78 Chemical Name: 3- Amino- 9, 13b- dihydro- 1H-...

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ALOCRIL Prescribing Information
aa® ALLERGAN ALOCRIL® (nedocromil sodium ophthalmic solution) 2% sterile DESCRIPTION ALOCRIL ® (nedocromil sodium ophthalmic solution) 2% is a clear, yellow, sterile solution for topical ophthalmic use.
Each mL contains: Active: Nedocromil sodium 20 mg/ mL (2%); Preservative: Benzalkonium chloride 0.01%; Inactives: Edetate disodium 0.05%; purified water; and...

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ALOCRIL Prescribing Information page 1


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Index: ED: 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.medicis.com/products/pi/pi_triaz.pdf
Benzoyl peroxide (C 14 H 10 O 4 ) is represented by the following chemical structure: TRIAZ 3% Gel contains Benzoyl Peroxide USP 3% as the active ingredient in a gel- based formulation consisting of: Purified Water USP, C12- 15 Alkyl Benzoate, Glycerin USP, Cetearyl Alcohol, Polyacrylamide (and) C13- 14 Isoparaffin (and) Laureth- 7, Glyceryl Stearate (and) PEG- 100 Stearate, Steareth...

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http://www.medicis.com/products/pi/pi_triaz.pdf page 1


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ProductCatalog
Pr o d u c t s 2 0 0 3/ 2004 PHARMA GROUP LIMITED Bioniche Life Sciences Inc.
CORPORATE PROFILE PHARMA GROUP LIMITED CONTENTS Acetylcysteine (Parvolex®)_ _ _ _ _ 2 Amiodarone _ _ _ _ _ _ _ _ _ _ _ 2 Ascorbic Acid _ _ _ _ _ _ _ _ _ _ _ 2 Ascorbic Acid (BetaC®) _ _ _ _ _ _ 2 B- Complex 100 Injection _ _ _ _ _ _ 3 Bacteriostatic Sodium Chloride _ _ _ 3 Carbachol Tablets _ _...

author: Kathy Vandermey
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http://www.bioniche.com/pdf/ProductCatalog.pdf
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ProductCatalog page 7


author: Kathy Vandermey
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http://www.bioniche.com/pdf/ProductCatalog.pdf
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ProductCatalog page 3


author: Kathy Vandermey
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IL133 page 1


author: Bradley
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Nasal Irrigation for Sinusitis and Rhinitis
- Nasal Irrigation for Sinusitis and Rhinitis Espanol pulsar AQUI Nasal Irrigation with SinuSal Inmunotek produces SinuSal, a salt mixture to carry out nasal irrigation and distributes Grossan Sinus Irrigator an attachment to the Water Pik Nasal Irrigation SinuSal SinuSal-XL Grossan Sinus Irrigator Nasal Irrigation Nasal irrigation with a saline solution is an old home remedy used...
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07907_07957-PIS.pdf page 1


author: catherine
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C:\Data\Acetadote\AP Letter Final 012304 .doc page 2


author: Paul Levine
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#09077: Sodium Ascorbate
- Sodium Ascorbate (Vitamin C) Sterile Solution Indications For use as a nutritive supplement of vitamin C in cattle, horses, sheep, swine, dogs and cats.
Each mL of sterile aqueous solution contains • Sodium ascorbate 250 mg • Monothioglycerol 0.5% w/v • Edetate disodium 0.1% w/v • Methylparaben (preservative) 0.18% w/v • Propylparaben (preservative...
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15276-PIS.doc page 2


author: phillip
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CDER Template - Replace Title Here
Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - July 2002 - ANDA Number Drug Name Applicant Approval Date 1 75-743 LISINOPRIL TABLETS, USP 2.5 MG, 5 MG, 10 MG, 20 MG, 30 MG, AND 40 MG PAR PHARMACEUTICAL, INC
7/1/02 3 75-776 LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS 10 MG/12.5 MG, 20 MG/12.5 MG, AND 20 MG/ 25 MG IVAX...
author: USERNAME
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ANDA Drug Approvals - November 2002
-U.S
Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - November 2002 ANDA Number Generic Drug Name Applicant Approval Date 1 75-410 OMEPRAZOLE DELAYED-RELEASE CAPSULES 10 MG, AND 20 MG KREMERS URBAN DEVELOPMENT COMPANY 11/1/02 2 40-376 EDETATE DISODIUM INJECTION, USP 150 MG/ML; PACKAGED IN 20 ML SINGLE-DOSE VIALS...
author: OGD
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FDA Drug Approvals List July 2002
- Drug Approvals for July 2002 Definitions and Notes Original New Drug Applications Original New Drug Application # 021409 Approval Date: 26-JUL-02 Trade Name: SINGULAIR Chemical Type: 3 Therapeutic Potential: S Dosage Form: GRANULE Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC Active Ingredient(s): MONTELUKAST SODIUM OTC/RX Status: RX Indication of Use: PROPHYLAXIS/CHRONIC...
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Prescription and OTC Drug Product List 12/2002
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACARBOSE TABLET; ORAL PRECOSE -D- BAYER 25MG N20482 004 MAY 29, 1997 DEC CAHN -D- 50MG N20482 001 SEP 06, 1995 DEC CAHN -D- + 100MG N20482 002 SEP 06, 1995 DEC CAHN -A- BAYER PHARMS 25MG N20482 004 MAY 29, 1997 DEC CAHN -A- 50MG N20482 001 SEP 06, 1995 DEC CAHN -A- + 100MG N20482 002 SEP 06, 1995 DEC CAHN ACYCLOVIR -A- CREAM;...
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Prescription and OTC Drug Product List 11/2002
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -A- AA ABLE 325MG;5MG N40478 001 NOV 08, 2002 NOV NEWA -A- AA 500MG;10MG N40473 001 NOV 06, 2002 NOV NEWA -A- AA 500MG;5MG N40477 001 NOV 06, 2002 NOV NEWA AMCINONIDE LOTION; TOPICAL -A- AMCINONIDE -A- AB ALTANA 0.1% N76329 001 NOV 06, 2002 NOV NEWA CYCLOCORT -D- + FUJISAWA...
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