| Document Date: 2009-03-31 16:04:27
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City Carville / Hanover / / Company Novartis Pharmaceuticals Corporation / Ames / / Country United States / / Event FDA Phase / / Facility Long Hansen’s Disease Center / / IndustryTerm treatment of other leprosy / oil / chemical name / oil-wax base / / MedicalCondition inflammatory reactions / headache / multibacillary leprosy / erythroderma / lymphadenopathy / vascular pain / burning pain / erythema nodosum leprosum / nausea / acquired immunodeficiency syndrome / proven dapsone-resistant leprosy / acneiform eruptions / fatigue / drowsiness / diarrhea / dapsone-resistant lepromatous leprosy / hepatitis / taste disorder / constipation / pruritus / Diminished vision / abdominal pain / lepromatous leprosy / nerve injury / cystitis / eosinophilic enteritis / Carcinogenesis / Phototoxicity / splenic infarction / erythema nodosum leprosum reactions / thromboembolism / itching / fever / neuralgia / skin and fatty tissue / pain / vomiting / concomitant disease / irritation / Dizziness / fatty tissue / depression / ichthyosis / hypokalemia / leprosy / rash / anemia / dapsone-sensitive multibacillary leprosy / eosinophilia / / MedicalTreatment Combination drug therapy / drug therapy / / Organization USPHS Gillis W. Long Hansen’s Disease Center / / / Position PRECAUTIONS General / / Product Soft Gelatin Capsules / rifampin / Lamprene / dapsone / HOW SUPPLIED Soft Gelatin Capsules / S-010 / / ProvinceOrState New Jersey / / Technology Pharmacokinetics / /
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NDA[removed]S-010 Page 3