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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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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...
author: MIS
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Genzyme Tissue Repair page 5
author: MIS
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Microsoft Word - Medication_Listing.doc
moclobemide (Manerix®) 150 mg tab nortriptyline (Aventyl®) 10 mg, 25 mg cap Continuing Care Pharmacy & Therapeutics Formulary ML- 01 SECTION SUBJECT Page 17 of 38 MEDICATION LISTING (ML) Medication Listing YY MM DD Original 00 10 30 Revised 02 01 14 Revised 03 10 23 paroxetine (Paxil®) 10 mg, 20 mg, 30 mg sertraline (Zoloft®) 25mg, 50 mg, 100 mg cap...
author: Wendy Daws
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CONCEPTS FOR CARE
1 65059
Wound Management Prior to Epicel Application ° The wound bed needs to be prepared more meticulously when Epicel is used than when using conventional autografts
° Replace homograft or other temporary covering if it begins to slough or if infection is apparent
° There are topical agents that are less harmful to epidermal cells in culture and can be...
author: Information Services
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CONCEPTS FOR CARE page 1
author: Information Services
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4:00 page 33
author: Christine Wildman
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What's new at CDER by Date
- U.S
Commit (nicotine polacrilex) Lozenge, GlaxoSmithKline Dextrose Injection USP, B
Benazepril Hydrochloride & Hydrochlorothiazide Tablets, Genpharm Benazepril Hydrochloride & Hydrochlorothiazide Tablets, Ivax Pharmaceuticals Intal (cromolyn sodium) Inhaler, Aventis Pharmaceuticals Intal (cromolyn sodium) Nebulizer, Aventis Pharmaceuticals Mercaptopurine Tablets,...
author: Paul Stauffer
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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
NDA 21-286/S2 2/12/03 2/25/03 - - Benicar (olmesartan medoxomil) Tablets,...
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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
ANDA 76-302 9/16/03 Nefazodone Hydrochloride Tablets, 50, 100, 150, 200 & 250 mg, Rx, Tentatively Approved Eon Labs, Inc
ANDA 76-072 1/30/03 Nefazodone Hydrochloride Tablets, 50, 100, 150, 200 & 250 mg,...
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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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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
2/5/02 5 76-097 CARTEOLOL HYDROCHLORIDE OPHTHALMIC SOLUTION, USP 1% NOVEX PHARMA 2/6/02 6 76-114 INDOMETHACIN EXTENDED-RELEASE...
author: USERNAME
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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...
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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...
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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 1/1998
Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 1: Jan 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACARBOSE ALPROSTADIL TABLET; ORAL INJECTABLE; INJECTION PRECOSE PROSTIN VR PEDIATRIC - DLT - @ BAYER 25MG N20482 004 - DLT - + PHARMACIA AND UPJOHN 0.5MG/ML N18484 001 - DLT - MAY 29, 1997 - 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 July 1999
Drug Approvals for July 1999 Definitions and Notes Original New Drug Applications Original Application #: 021057 Approval Date: 29-JUL-99 Trade Name: ANTAGON Chemical Type: 1 Therapeutic Potential: P Dosage Form: INJECTABLE Applicant: ORGANON INC Active Ingredient(s): GANIRELIX ACETATE OTC/RX Status: RX Indication(s): Provides for the inhibition of premature LH surges in women...
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DDPA October 1995
19-672 EFIDAC 24 ALZA BROMPHENIRAMINE MALEATE 20-OCT-95 PSEUDOEPHEDRINE/ PALO ALTO, CA 16MG BROMPHENIRAMINE 94303 PSEUDOEPHEDRINE (TABLET, HYDROCHLORIDE EXTENDED RELEASE) 240MG (ANTIHISTAMINE/DECONGESTANT) (OTC) 20-520 ZANTAC 75 GLAXO WELLCOME RANITIDINE HYDROCHLORIDE 23-OCT-95 (TABLET) RES TRIANGLE PK, NC EQ 75MG BASE 27709 (HISTAMINE H-2 RECEPTOR ANTAGONIST) (OTC) 20-298 ZYLOPRIM...
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DDPA January 1995
50-703 BACTROBAN SMITHKLINE BEECHAM MUP IROCIN CALCIUM 20-JAN-95 (OINTMENT) KING OF PRUSSIA, PA EQ 2% BASE 19406 (ANTIBACTERIAL) 50-710 ZITHROMAX PFIZER AZITHROMYCIN DIHYDRATE 27-JAN-95 (POWDER, GROTON, CT EQ 100MG BASE/5ML FOR RECONSTITUTION) 06340 EQ 200MG BASE/5ML EQ 1GM/PACKET (ANTIBIOTIC, MACROLIDE) ***ORIGINAL ABBREVIATED NDAs*** 73-580* MEBENDAZOLE COPLEY PHARM MEBENDAZOLE 04...
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Body Piercing Problems - Quest Diagnostics Patient Health Library
Body Piercing Problems Home Treatment Most body piercing wounds can be cared for at home.
This will help prevent problems and promote healing.
Never apply ice directly to the skin.
Put a layer of fabric or paper towel between the cold pack and the skin.
After the first 48 hours, if swelling and bruising are not present, soak the wound in warm water for 20 minutes, 3 to 4...
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Snake and Lizard Bites - Quest Diagnostics Patient Health Library
Snake and Lizard Bites Home Treatment Poisonous snake or lizard bite If you were bitten by a snake or lizard that you know or suspect is poisonous, call 911 or other emergency services immediately.
Leave it on for 30 minutes.
(5.1 cm) wide band or cloth about 2 in.
A dead snake, even one with a severed head, can bite and release venom by reflex action for up to an hour after...
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Animal and Human Bites - Quest Diagnostics Patient Health Library
Animal and Human Bites Home Treatment Minor animal and human bites can be treated effectively at home.
Mild bleeding can almost always be stopped within 15 minutes by applying direct pressure to the wound.
For more information, see Are stitches, staples, or skin adhesives necessary?
These bites are at low risk for infection.
Do not use liquid skin bandages and moisture...
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Cleaning and Bandaging a Wound - Quest Diagnostics Patient Health Library
Cleaning and Bandaging a Wound Topic Overview Skin wounds need to be thoroughly cleaned as soon as possible to reduce the risk of infection and scarring and to promote healing.
Remove or cut clothing from around the wound.
Minor wounds Wash your hands well with soap and water, if available.
(Moderate scrubbing may be needed if the wound is very dirty.) Hard scrubbing may...
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