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Documents 1-25 out of over 431 found
  Current Search:  amiodarone: 575, hydrochloride: 3359  

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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.
News Release Bioniche Receives FDA Tentative Approval For Sterile Injectable 23/07/02 - Specialty Pharmaceutical Division Takes Another Key Step in Building US Presence - BELLEVILLE, Ontario, July 23, 2002 - Bioniche Life Sciences Inc...
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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.
News Release Bioniche Receives FDA Approval For Sterile Injectable 17/10/02 - New product adds to growing Specialty Pharma portfolio - BELLEVILLE, Ontario, October 17, 2002 - Bioniche Life Sciences Inc.
This approval strengthens...
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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.
Source: TSX Inc.
Vials in the U.S.
market.
Sales of Cordarone I.V.
and grew to almost $162 million U.S.
Amiodarone is one of the most widely used drugs in the cardiovascular care setting.
About Bioniche Pharma Group...
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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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Bioniche
February 12, 2008 Bioniche Reports Fiscal 2008 Second Quarter February 8, 2008 Bioniche Receives $5 Million Capital Financing Support to Scale-up E.
(TSX:BNC) today announced that the Company's specialty pharmaceutical business unit, Bioniche Pharma Group Limited, received approval from the U.S.
The American Society of Health-System Pharmacists (ASHP), the professional...
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Baxter s Products & Services Directory page 14


author: Center for One Baxter subject: For questions about our Products and Services
duplicates:
http://www.baxter.com/customers/products_svcs/2003_products_and_services_directory.pdf
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Baxter s Products & Services Directory
Tablets MESNEX* (MESNA) Product Information: Bristol Myers- Squibb Medical Services 800- 426- 7644 ALFENTANIL HYDROCHLORIDE INJECTION ATIVAN (LORAZEPAM) INJECTION AMIODARONE HYDROCHLORIDE INJECTION ATRACURIUM BESYLATE INJECTION ATROPINE SULFATE INJECTION, USP BUMETANIDE INJECTION BUTORPHANOL TARTRATE INJECTION, USP CISplatin INJECTION DILTIAZEM HCI INJECTION...

author: Center for One Baxter subject: For questions about our Products and Services
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http://www.barrlabs.com/overview/annual/BRL_AR2001.pdf
Barr Laboratories, Inc.
This case involves raw material patents.
Downey Chairman 6 This year, we will add the challenge of integrating our Company with Duramed to the commitments that I am asking our employees to make.
Two other products in our oral contraceptive pipeline involve patent challenges.
In January 2001, we received approval for Amiodarone ...

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http://www.barrlabs.com/overview/annual/BRL_AR2001.pdf page 18


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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
duplicates:
http://www.bioniche.com/pdf/ProductCatalog.pdf
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ProductCatalog page 3


author: Kathy Vandermey
duplicates:
http://www.bioniche.com/pdf/ProductCatalog.pdf
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Drug Approvals - A
NDA 5-619/S-016 3/30/01 5/16/02 - - Aminosyn, 5%, 7%, 8.5%, 8.5% w/Electrolytes & 10%, Rx Abbott Laboratories NDA 17-673/S-065 17-789/S-051 6/12/03 7/8/03 Aminosyn 5%, 7%, 8.5%, 8.5% w/Electrolytes & 10%, Rx Abbott Laboratories NDA 17-673/S-066, 17-789/S-052, 18-429/S-019, 19-374/S-015, 19-398/S-016, 19-437/S-015, 19-438/S-014, 19-492/S-016 10/25/02 10/30/02 Aminosyn II, 15% pharmacy...
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Prescription and Over-the-Counter Drug Product List: 12/2003
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, ACETAMINOPHEN AND CAFFEINE >A> + MIKART 750MG;50MG;40MG N40496 001 DEC 23, 2003 DEC NEWA ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE TABLET; ORAL DARVOCET A500 >D> + AAIPHARMA 500MG;100MG N76429 001 SEP 10, 2003 DEC CTNA >A> + 500MG;100MG N76429 001 SEP 10, 2003 DEC CTNA...
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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,...

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http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt
"NIZATIDINE USP AS MANUFACTURED IN ANDHRA PRADESH, INDIA" 14038 19-Mar-99 LEO PHARMACEUTICAL PRODUCTS LTD "HEPARIN SODIUM DRUG SUBSTANCE AS MANUFACTURED IN ESBJERG, DENMARK, MIDDLESBROUGH, UNITED KINGDOM, AND CORK, IRELAND" 14039 19-Mar-99 LEO PHARMACEUTICAL PRODUCTS LTD "HEPARINASE DRUG SUBSTANCE AS MANUFACTURED IN BALLERUP, DENMARK" 14040 11-Mar-99 TEVA GROUP "MUPIROCIN AS...

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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
OF DEGUSSA, HAM, ENGLAND SANOFI SA AMIODARONE HCL AS MANUF BY SEMPA-CHIMIE IN...

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OGD Suitability Tracking Reports (Sorted by Petition Number) as of 1/5/2004
- TABLET; ORAL Approved 2/28/2003- BACLOFEN 10 mg, 20 mg - 02P-0078/CP1 KLEINFELD, KAPLAN & BECKER - ORALLY DISINTEGRATING TABLETS Approved 2/5/2003- OXYCODONE 5mg, 7.5mg, 10mg ACETAMINOPHEN 300mg - 02P-0105/CP1 LACHMAN CONSULTANT SERVICES - TABLETS Approved 8/6/2002- CARISOPRODOL 350 mg - 02P-0138/CP1 LACHMAN CONSULTANT SERVICES - ORALLY DISINTEGRATING TABLETS Withdrawn 7/25/2002-...
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OGD Suitability Tracking Reports (Sorted by Drug Name) as of 1/5/2004
- TABLET; FOR ORAL SUSPENSION Approved 6/13/2000- ALBUTEROL SULFATE.083% (base) - 02P-0448/CP1 SENSORMEDICS CORPORATION - INHALATION SOLUTION Denied 12/17/2003- ALBUTEROL SULFATE 0.0417% - 00P-0913/CP1 MCDERMOTT, WILL AND EMERY - SOLUTION; INHALATION Approved 6/13/2000- AMINO ACIDS 10% 1000mL & 2000mL - 00P-1470/CP1 BAXTER HEALTHCARE CORP - INJECTION Approved 1/11/2001- AMIODARONE...
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ANDA Approvals - September 2003
9/4/2003- 6 76-163 AMIODARONE HYDROCHLORIDE INJECTION 50 MG/ML; PACKAGED IN 150 MG/3 ML, 450 MG/9 ML, AND 900 MG/18 ML SINGLE-USE VIALS - SICOR PHARMACEUTICALS, INC
9/12/2003- 18 75-145 SELEGILINE HYDROCHLORIDE CAPSULES 5 MG - AAI PHARMA 9/15/2003- 19 75-763 NEFAZODONE HYDROCHLORIDE TABLETS 50 MG, 100 MG, 150 MG, 200 MG, AND 250 MG - IVAX PHARMACEUTICALS,...
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Prescription and Over-the-Counter Drug Product List: 9/2003
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN >A> + MIKART 325MG/15ML;7.5MG/15ML N40482 001 SEP 25, 2003 SEP NEWA ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET; ORAL >A> OXYCODONE AND ACETAMINOPHEN >A> AA WATSON LABS 325MG;7.5MG N40535 001 SEP 05, 2003 SEP NEWA >A> AA 325MG...
author: AUTHOR
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Prescription and Over-the-Counter Drug Product List: 4/2003
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL FIORICET -D- AB + NOVARTIS 325MG;50MG;40MG N88616 001 NOV 09, 1984 APR CAHN -A- AB + WATSON PHARMS 325MG;50MG;40MG N88616 001 NOV 09, 1984 APR CAHN ACYCLOVIR CAPSULE; ORAL ACYCLOVIR -A- AB AAIPHARMA 200MG N74833 001 APR 22, 1997 APR CAHN -D- AB AESGEN 200MG N74833 001 APR 22, 1997...
author: AUTHOR
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OGD, First Time Approvals - June 2000
Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Office of Generic Drugs Approved Drugs First Time Generic June 2000 Established Name/Dosage Form and AP Date MIDAZOLAM HYDROCHLORIDE INJECTION 1 MG (BASE)/ML (SYRINGE) 5 MG (BASE)/ML 6/20/00 (SYRINGE) HYDROXYUREA CAPSULES, USP 250 MG 6/26/00 AMIODARONE HYDROCHLORIDE...
author: USERNAME
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ANDA Tentative Approvals -August 2001
Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Tentative Approvals - August 2001 - - ANDA Number Drug Name Applicant Tentative Approval Date 1 75-852 MILRINONE LACTATE INJECTION 1 MG (BASE)/ML BAXTER PHARMACEUTICAL PRODUCTS, INC
8/2/01 2 75-022 BUSPIRONE HYDROCHLORIDE TABLETS, USP 15 MG (NOTE: 5 MG & 10 MG STRENGTHS WERE...
author: USERNAME
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CDER Template - Replace Title Here
Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Tentative Approvals - 2002 - ANDA Number Drug Name Applicant Tentative Approval Date 1 75-753 FENOFIBRATE CAPSULES (MICRONIZED) 67 MG NOVOPHARM LIMITED 4/9/02 2 76-108 AMIODARONE HYDROCHLORIDE INJECTION 50 MG/ML FAULDING PHARMACEUTICAL CO
4/12/02 3 76-172 METFORMIN ...
author: USERNAME
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CDER Template - Replace Title Here
Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Tentative Approvals - July 2002 - ANDA Number Drug Name Applicant Tentative Approval- Date 1 75-706 LORATADINE AND PSEUDOEPHEDRINE SULFATE EXTENDED-RELEASE TABLETS-------- 10 MG/240 MG (24-HOUR FORMULATION) ANDRX PHARMACEUTICALS, LLC 7/9/02 2 75-919 MOMETASONE FUROATE TOPICAL SOLUTION,...
author: USERNAME
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