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16. 2015 Initialed LJafari/1. 16. 2015 SBrar/1. 29. 2015 JManynard/1. 29. 2015 Finalized Nabavian/1. Submit revised labeling incorporating the changes shown in the attached marked up labels via email to Sadaf.Nabavian fda.hhs. Thank you. Tuzistra ER Oral Suspension Tris Pharma Inc. Dear Mr. Groner Your submission dated June 27 2014 for Tuzistra ER suspension is currently under review and we have the following comment. The Division also informed Tris Pharma of an ongoing internal discussion...
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What is center for drug evaluation?
Center for drug evaluation is a regulatory body responsible for evaluating the safety and efficacy of drug products.
Who is required to file center for drug evaluation?
Pharmaceutical companies are required to file center for drug evaluation for their drug products.
How to fill out center for drug evaluation?
Center for drug evaluation must be filled out according to the guidelines provided by the regulatory body.
What is the purpose of center for drug evaluation?
The purpose of center for drug evaluation is to ensure the safety and efficacy of drug products before they are approved for use.
What information must be reported on center for drug evaluation?
Center for drug evaluation must include detailed information on the drug product, including its ingredients, dosage, and potential side effects.
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