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NDA-I1: NDA Approval Letter
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Document Date: 2009-03-31 16:06:52


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IndustryTerm

dairy products / machinery / multivalent cation-containing products / metal cations / food / chemical structure / /

MedicalCondition

loss of consciousness / Acute Cystitis / Pseudomonas / tremors / allergic reaction / seizures / hallucinations / skin rash / hepatic necrosis / colitis / CNS disorders / Severe hypersensitivity / diarrhea / hypersensitivity / urinary tract infections / cardiac arrest / Complicated Urinary Tract Infections / organisms causing infection / renal dysfunction / infections / acute uncomplicated pyelonephritis / paranoia / uncomplicated urinary tract infections / exaggerated sunburn / C. difficile colitis / Serious anaphylactic reactions / insomnia / stable chronic cirrhosis / occasionally fatal hypersensitivity / respiratory failure / dyspnea / acute hepatic insufficiency / severe phototoxicity / phototoxicity / itching / fever / seizure / pain / urticaria / severe cerebral arteriosclerosis / epilepsy / clinical infections / dizziness / inflammation / gram-negative microorganisms Escherichia coli Klebsiella pneumoniae Proteus mirabilis Pseudomonas / depression / rash / Pseudomembranous colitis / complicated urinary tract infection / lightheadedness / eosinophilia / status epilepticus / /

MedicalTreatment

emergency treatment / drug therapy / /

Organization

DOSAGE AND ADMINISTRATION / /

Position

physician / General / PRECAUTIONS General / /

Product

probenecid / VIDEX / CIPRO XR / polyethylene glycol / Omeprazole / OR CHEW THE TABLET / theophylline / sucralfate / M-16 / epinephrine / ciprofloxacin hydrochloride / CIPRO / didanosine / ciprofloxacin / /

Technology

Pharmacokinetics / recombination / /

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