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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 DOBUTAMINE...

author: Center for One Baxter subject: For questions about our Products and Services
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Drug Approvals - M
NDA 21-408 10/17/02 10/21/02 10/17/02 Meperidine Hydrochloride Tablets USP , 50 mg & 100 mg, Rx Caraco Pharmaceutical Laboratories Ltd
ANDA 40-446 8/8/02 4/9/03 Meperidine Hydrochloride Tablets USP, 50 mg & 100 mg, Rx Mallinckrodt Inc
ANDA 40-352 6/13/00 6/16/00 - 8/4/03 < STRONG> Meperidine Hydrochloride Tablets USP, 50 mg & 100 mg
ANDA...
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http://www.baxter.com/products/medication_management/infusion_pumps/syringe_pumps/downloads/PCAII.pdf
P r e f i l l e d S y r i n g e s Catalog Number D e s c r i p t i o n 2 L 3 0 0 0 Morphine Sulfate Injection, USP, CII 1 mg/ mL, 50 mL 2 L 3 0 0 2 Meperidine Hydrochloride Injection, USP, CII 10 mg/ mL, 50 mL 2 L 3 0 0 3 Morphine Sulfate Injection, USP, CII 5 mg/ mL, 50 mL A c c u r a c y Dose: ± 3% average linear displacement Rate: ± 3% average linear...

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http://www.baxter.com/products/medication_management/infusion_pumps/syringe_pumps/downloads/PCAII.pdf page 4


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5612 Syndeo Brochure.KL page 1


author: MacAdmin
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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/dmf/text/4Q2003ACTIVETYPE2TEXT.txt
11274 27-Dec-94 FUJI CHEMICAL INDUSTRIES LTD "DINOPROSTONE (PROSTAGLANDIN E2) MANUFACTURED IN TOYAMA, JAPAN." 11276 29-Dec-94 TAKASAGO INTERNATIONAL CORP "A-87172.0 MANUFACTURED IN SHIZUOKA PREFECTURE, JAPAN." 11280 04-Jan-95 PLIVA "MESALAZINE N MANUFACTURED IN SAVSKI MAROF, CROATIA" 11282 05-Jan-95 KANEKA CORP "KPM-1648 MANUFACTURED IN HYOGO, JAPAN" 11287 29-Dec-94 DOW CHEMICAL CO ...

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http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls
IN BUDAPEST, HUNGARY PLANTEX LTD CHEM AND PHARM WORKS IMIPRAMINE HYDROCHLORIDE LUNDBECK PHARMACEUTICALS ITALY SPA IMIPRAMINE HYDROCHLORIDE AVENTIS PHARMA SA PROMETHAZINE HCL GRUPPO LEPETIT SPA D-PROPOXYPHENE HYDROCHLORIDE BULK SCHERING AG ETHINYL ESTRADIOL ROCHE COLORADO CORPORATION
IN THE NORTH CHICAGO, ILLINOIS FACILITIES COSMA SPA METOCLOPRAMIDE HCL PHARMACIA...

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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 TABLET...
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Prescription and Over-the-Counter Drug Product List: 8/2003
4 >D> AA + ORTHO MCNEIL PHARM 300MG;60MG N85055 004 AUG DISC >A> @ 300MG;60MG N85055 004 AUG DISC ACETAMINOPHEN; HYDROCODONE BITARTRATE SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN >A> AA + MALLINCKRODT 500MG/15ML;10MG/15ML N40508 001 AUG 29, 2003 AUG NEWA >D> MIKART 500MG/15ML;5MG/15ML N81226 001 OCT 27, 1992 AUG CTEC >A> AA 500MG/15ML;5MG/15ML N81226 001 OCT 27, 1992 AUG...
author: AUTHOR
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Prescription and Over-the-Counter Drug Product List: 6/2003
>D> AP + WYETH AYERST 5,000 UNITS/VIAL N17055 001 JUN DISC >A> @ 5,000 UNITS/VIAL N17055 001 JUN DISC >D> AP + 10,000 UNITS/VIAL N17055 002 JUN DISC >A> @ 10,000 UNITS/VIAL N17055 002 JUN DISC GUANABENZ ACETATE TABLET; ORAL GUANABENZ ACETATE >D> AB WATSON LABS EQ 8MG BASE N74025 002 FEB 28, 1994 JUN CRLD >A> AB + EQ 8MG BASE N74025 002 FEB 28, 1994 JUN CRLD >D> WYTENSIN >D> AB WYETH...
author: AUTHOR
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Prescription and Over-the-Counter Drug Product List: 5/2003
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, APAP, AND CAFFEINE -A- AB AXIOM PHARM 325MG;50MG;40MG N89536 001 FEB 16, 1988 MAY CAHN -D- AB HALSEY 325MG;50MG;40MG N89536 001 FEB 16, 1988 MAY CAHN ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -A- AA ABLE 500MG;7.5MG...
author: AUTHOR
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ANDAs Approvals - June 2000
40-372 PROMETHAZINE ABBOTT LABORATORIES 6/8/00 HYDROCHLORIDE INJECTION, USP 25 MG/ML (SYRINGE) 50 MG/ML (SYRINGE) 3
40-352 MEPERIDINE HYDROCHLORIDE MALLINCKRODT INC
6/20/00 HYDROCHLORIDE INJECTION 1 MG (BASE)/ML (VIALS) 5 MG (BASE)/ML (VIALS) 8
75-293 MIDAZOLAM ABBOTT LABORATORIES 6/20/00 HYDROCHLORIDE INJECTION 1 MG (BASE)/ML (VIALS) 5 MG (BASE...
author: USERNAME
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ANDA Approvals - August 2002
Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - August 2002 - ANDA Number Generic Drug Name Applicant Approval Date 1 40-452 ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 MG/30 MG ABLE LABORATORIES, INC
8/2/02 7 76-202 PENTAZOCINE HYDROCHLORIDE AND ACETAMINOPHEN TABLETS 25 MG (BASE)/650 MG AMIDE...
author: OGD
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1997 Abbreviated New Drug Applications (Generic Drugs)
074946 11/19/1997 3/30/1998 Adriamycin PFS (Doxorubicin Hydrochloride) Injection ,- Adria Laboratories 63165/S3, S5, S6 7/9/1993 8/8/2002 Albuterol Inhalation Aerolsol, 90 mcg/Actuation
64136 9/30/96 4/13/99 Clomipramine Hydrochloride [2 MB] Taro Pharmaceuticals 074694 12/13/1996 12/3/1997 Clomipramine Hydrochloride Capsules, 25, 50, & 75 mg
74-648 3/18/97 4/8...
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Prescription and OTC Drug Product List 8/2002
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL ACETAMINOPHEN AND CODEINE PHOSPHATE -A- AA ABLE 300MG;30MG N40452 001 AUG 01, 2002 AUG NEWA -A- AA 300MG;60MG N40459 001 AUG 01, 2002 AUG NEWA ACETAMINOPHEN; PENTAZOCINE HYDROCHLORIDE TABLET; ORAL ACETAMINOPHEN AND PENTAZOCINE HCL -A- AB AMIDE PHARM 650MG;EQ 25MG BASE N76202 001...
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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
Bulk, Group C Meningococcal Polysaccharide Vaccine Group A Meningococcal Polysaccharide Vaccine Group C Meningococcal Polysaccharide Vaccine Group A and C Menotropin Meperidine HCl Injection Mephentermine Sulfate Mepivacaine HCl Mepivacaine HCl and Levonordefrin Meprobamate Injection Meprylcaine HCI and Epinephrine Mercaptomerin Sodium Mersalyl with theophylline Merethoxylline...

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 - ADD - @ COPLEY PHARM...
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Prescription and OTC Drug Product List 9/1999
Prescription and Over-the-Counter Drug Product List - 19th Edition Cumulative Supplement Number 9: September 1999 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE ATENOLOL CAPSULE; ORAL TABLET; ORAL - DLT - BUTALBITAL, ACETAMINOPHEN, CAFFEINE ATENOLOL - DLT - AB GRAHAM DM 325MG;50MG;40MG N88758 001 - ADD - MYLAN 25MG...
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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...
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Prescription and OTC Drug Product List 1/1999
Prescription and Over-the-Counter Drug Product List - 19th Edition Cumulative Supplement Number 1: January 1999 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE BENDROFLUMETHIAZIDE; NADOLOL CAPSULE; ORAL TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN CORZIDE - ADD - AA MALLINCKRODT 500MG;5MG N88956 001 - ADD -...
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Prescription and OTC Drug Product List 6/2000
Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 6: June 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETOHEXAMIDE BLEOMYCIN SULFATE TABLET; ORAL INJECTABLE; INJECTION ACETOHEXAMIDE BLEOMYCIN - DLT - AB BARR 500MG N70870 001 - ADD - AP GENSIA SICOR PHARMS EQ 15 UNITS BASE/VIAL N65033 001 - DLT - FEB...
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PDPL
- ADD - + ADV MAGNETICS EQ 11.2MG IRON/ML N20416 001 ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE - ADD - AUG 30, 1996 TABLET; ORAL-21 ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL 1/35-21 FLUPHENAZINE DECANOATE - DLT - AB WATSON LABS 0.035MG;1MG N72720 001 - DLT - DEC 30, 1991 INJECTABLE; INJECTION ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL 1/50-21 FLUPHENAZINE DECANOATE - DLT - AB WATSON...
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