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http://www.fda.gov/cder/orange/appendix_a.txt
400, ERYTHROMYCIN ETHYLSUCCINATE E.E.S., ERYTHROMYCIN ETHYLSUCCINATE EC-NAPROSYN, NAPROXEN ECONAZOLE NITRATE, ECONAZOLE NITRATE ECONOCHLOR, CHLORAMPHENICOL ECONOPRED PLUS, PREDNISOLONE ACETATE ECONOPRED, PREDNISOLONE ACETATE EDECRIN, ETHACRYNATE SODIUM EDECRIN, ETHACRYNIC ACID EDETATE DISODIUM, EDETATE DISODIUM EDEX, ALPROSTADIL EDROPHONIUM CHLORIDE PRESERVATIVE FREE, EDROPHONIUM...
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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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Prescription and OTC Drug Product List 6/2002
45 -D- + NOVARTIS 1MG/ML N05929 001 JUN CAHN -A- XCEL PHARMS 1MG/ML N05929 001 JUN CAHN DILTIAZEM HYDROCHLORIDE INJECTABLE; INJECTION CARDIZEM -D- AP + AVENTIS PHARMS 5MG/ML N20027 001 OCT 24, 1991 JUN CAHN -D- + 25MG/VIAL N20027 003 AUG 18, 1995 JUN CAHN -A- AP + BIOVAIL 5MG/ML N20027 001 OCT 24, 1991 JUN CAHN -A- + 25MG/VIAL N20027 003 AUG 18, 1995 JUN CAHN DILTIAZEM MALATE;...
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http://www.fda.gov/cder/da/ddpa94.wpd
18 473 VENTOLIN GLAXO ALBUTEROL 02 FEB 94 (AEROSOL, METERED) RES TRIANGLE PK, NC 0.09MG/INH 27709 (LABELING REVISION PRECAUTIONS; PATIENT'S INSTRUCTIONS FOR USE) 19 548 TORNALATE STERLING WINTHROP BITOLTEROL MESYLATE 02 FEB 94 (SOLUTION) MALVERN, PA 0.2% 19355 (LABELING REVISION WARNINGS; OVERDOSAGE; DOSAGE AND ADMINISTRATION; PRECAUTIONS) 16 659 NORINYL 1+50 28 DAY SYNTEX (FP)...
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C:\Data\Wpfiles\Ap18123s page 1
author: Margaret Kober
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http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt
"7-ADCA MANUFACTURED IN DELFT, THE NETHERLANDS (PREVIOUSLY AN ANTIBIOTIC FILE)" 10180 06-Dec-83 SYNPAC CHEMICALS LIMITED "PENICILLIN G INTERMEDIATES MANUFACTURED IN CAMBOIS, ENGLAND (PREVIOUSLY AN ANTIBIOTIC FILE)" 10185 12-Apr-93 DIOSYNTH BV "NORETHINDRONE ACETATE PROCESS II MANUFACTURED IN OSS, THE NETHERLANDS" 10190 08-Apr-93 TAKASAGO INTERNATIONAL CORP "4-AA, OR [3R-[3A(R*),4B]]...
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Prescription and OTC Drug Product List 6/2002
ACTHAR GEL -D- BC + QUESTCOR PHARMS 40 UNITS/ML N08372 006 JUL DISC -A- @ 40 UNITS/ML N08372 006 JUL DISC DIATRIZOATE SODIUM SOLUTION; ORAL, RECTAL HYPAQUE -D- AMERSHAM HLTH 40% N11386 003 JUL DISC -A- @ 40% N11386 003 JUL DISC DICLOFENAC SODIUM GEL; TOPICAL SOLARAZE -A- + BIOGLAN PHARMA 3% N21005 001 OCT 16, 2000 JUL CAHN -D- + BIOGLAN PHARMA PLC 3% N21005 001 OCT 16, 2000 JUL CAHN...
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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
Conc.( equine) 3.00 mL Dipyridamole 0.14 mg Dobutamine HCI 0.90 mg 5.00 1.10 2.17 3.57 1.80 1.80 1.80 1.80 45.45 5.00 1.25 5.56 11.60 + 0.50 + 35.70 + 71.43 16.70 + 17.20 + 0.70 + 0.70 + 111.00 + 200.00 + 1.00 357.00 0.003 + 0.50 + 166.67 1.00 4.00 0.50 + 1.00 8.77 3.40 + 16.67 1.67 37.70 5.56 40 Dopamine HCI Dopamine HCl in Dextrose Doxapram HCI Injection Doxorubicin HCI for...
author: FDA / CBER
subject: December 1987 Guideline
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http://www.deltec.com/images/objects/Products/PDFs/CADDMicro/19310_Micro_Stability.pdf
Drug Diluent Concentration Room Temp Refrigerated Reference Bleomycin Sulfate Sterile Water 0.5 units/ ml 24 hours (25° C) TH 5 or 1 unit/ ml Normal Saline 0.6 units/ ml 28 days* TH 2 Bupivicaine HCl Normal Saline 1.25 mg/ ml 32 days (23° C) 32 days (3° C) 6 Cytarabine Bacteriostatic 40 mg/ ml 15 days (25° C) 15 days (4° C) 2, 5 Water for Injection and 80 mg/...
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http://www.deltec.com/images/objects/Products/PDFs/CADDMicro/19310_Micro_Stability.pdf page 2
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FDA DRUG AND DEVICE PRODUCT APPROVALS
74-776 TIMOLOL MALEATE BAUSCH AND LOMB TIMOLOL MALEATE 26-JUL-96 (SOLUTION/DROPS) TAMPA, FL 0.5% 33637 (BETA ADRENERGIC BLOCKER) 74-778 TIMOLOL MALEATE BAUSCH AND LOMB TIMOLOL MALEATE 26-JUL-96 (SOLUTION/DROPS) TAMPA, FL 0.25% 33637 (BETA ADRENERGIC BLOCKER) 74-465 TIMOLOL MALEATE ADV REMEDIES TIMOLOL MALEATE 30-JUL-96 (SOLUTION/DROPS) SOMERSET, NJ 0.25% 08873 (BETA ADRENERGIC...
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