| Document Date: 2009-06-07 20:54:51
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City Rochester / Bristol / / Company King Pharmaceuticals Inc. / Monarch Pharmaceuticals Inc. / TN 37620 / Parkedale Pharmaceuticals Inc. / / Event Product Issues / / Facility Laboratory Deviations / / IndustryTerm hazardous machinery / intravenous solution / above listed infusion solutions / owned subsidiary / electrolyte management / sterile parenteral antibiotic product / infusion solution / drug products / invert sugar solution / / MedicalCondition ataxia / fatal colitis / circumoral paresthesia / difficile associated diarrhea / Pseudomonas / apnea and neuromuscular blockade / bacterial infections / common cold / Carcinogenesis / vertigo / serious infections / muscle weakness / apnea / itching / formication / fever / lethargy / chronic infections / viral infections / numbness / acute renal insufficiency / renal insufficiency / Respiratory muscle paralysis / concomitant disease / apnea / respiratory arrest / urticaria / bacterial infection / stomach cramps / mild diarrhea / diarrhea / infection / clinical infections / dizziness / pruritus / infections / paresthesia / acute renal failure / disorders / respiratory distress / / MedicalTreatment peritoneal dialysis / antibiotics / hemodialysis / drug therapy / intravenous infusion / / Organization Direct Intermittent Administration / INTRAVENOUS ADMINISTRATION / DOSAGE AND ADMINISTRATION / Intramuscular Administration / Dosage Unit / / Position PRECAUTIONS General / physician / / Product Colistimethate / dextrose / Coly-Mycin M / cephalothin / Sterile Water for Injection / Renal Function Renal Function Degree / renal function / / ProvinceOrState Michigan / / Technology dialysis / /
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NDA[removed]S-026 Page 3 Coly-Mycin® M Parenteral (Colistimethate for Injection, USP)