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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 22-362 CHEMISTRY REVIEW(S) CHEMISTRY REVIEW NDA 22-362 (HCl) for Oral Suspension Danish Sank yo, Inc. Elisabeth Chile, Ph.D. OND QA DPA
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How to fill out for oral suspension
How to fill out for oral suspension?
01
Shake the bottle well before each use to ensure proper suspension of the medication.
02
Use the measuring device provided with the medication to accurately measure the prescribed dose.
03
Pour the measured dose of oral suspension into a clean medication cup.
04
Administer the oral suspension directly into the mouth using the medication cup. Make sure the patient swallows all the medication.
05
After use, wash the measuring device and medication cup with warm soapy water and allow them to air dry.
Who needs oral suspension?
01
Children who have difficulty swallowing pills or capsules.
02
Patients with certain medical conditions, such as dysphagia (difficulty swallowing) or gastrointestinal issues, that make swallowing solid medications challenging.
03
Individuals who prefer liquid medications or have a strong aversion to swallowing pills.
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What is for oral suspension?
Oral suspension refers to a liquid form of medication that is intended to be taken by mouth.
Who is required to file for oral suspension?
The filing of oral suspension is typically required by pharmaceutical companies or manufacturers who produce medication in a liquid form for oral consumption.
How to fill out for oral suspension?
To fill out for oral suspension, pharmaceutical companies or manufacturers need to follow the guidelines provided by the regulatory authorities, including providing accurate information about the medication, its composition, dosage instructions, and any potential side effects.
What is the purpose of for oral suspension?
The purpose of oral suspension is to provide a convenient and easily consumable form of medication, particularly for individuals who have difficulty swallowing pills or tablets.
What information must be reported on for oral suspension?
The information that must be reported on for oral suspension includes the medication's name, active ingredients, concentration, dosage instructions, potential side effects, and any special storage requirements.
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