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Abeygunawardana Please refer to your New Drug Application NDA dated June 26 2013 received June 27 2013 submitted under section 505 b of the Federal Food Drug and Cosmetic Act FDCA for for oral suspension 100 mg. Fda.gov/AboutFDA/CentersOffices/CDER/ucm090142. htm. REPORTING REQUIREMENTS We remind you that you must comply with reporting requirements for an approved NDA 21 CFR 314. This required study is listed below. We reference the deferral granted under NDA 203045 in the March 16 2012 new...
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01
Shake the bottle of oral suspension 100 before use.
02
Use a measuring device provided with the medication to measure the correct dose.
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Pour the measured dose of oral suspension into a spoon or directly into the mouth.
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Swallow the medication without chewing or crushing it.
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If required, follow the instructions on whether to take the oral suspension with or without food.
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Always complete the full course of the medication as prescribed by your healthcare professional.

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Oral suspension 100 is typically prescribed to individuals, including children, who require a liquid form of medication.
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Individuals with certain medical conditions, such as gastrointestinal disorders or throat infections, may also be prescribed oral suspension 100.
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Only use this medication if it has been specifically prescribed for you or your child. Follow the guidance of your healthcare professional.
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It is a medication in liquid form that is meant to be taken orally.
Manufacturers or distributors of oral suspension 100 are required to file for it.
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The purpose of for oral suspension 100 is to ensure that the medication meets regulatory standards and is safe for consumption.
Information such as the ingredients, manufacturing process, and safety data must be reported on for oral suspension 100.
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