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Page 1 2PH00018×Application No. OH0126641 Action Date: July 12, 2021, Effective Date: August 1, 2021, Expiration Date: July 31, 2026 Ohio Environmental Protection Agency Authorization to Discharge
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How to fill out expiration dating extensionfda
How to fill out expiration dating extensionfda
01
Determine if the product requires an expiration dating extension from the FDA.
02
Gather all necessary information/documentation for the extension request.
03
Submit a formal request to the FDA for the expiration dating extension.
04
Await FDA approval or denial of the extension request.
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Implement the expiration dating extension as approved by the FDA.
Who needs expiration dating extensionfda?
01
Companies or manufacturers of products that require an expiration date extension as determined by the FDA.
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What is expiration dating extensionfda?
Expiration dating extensionfda refers to the process of extending the expiration date of a product approved by the FDA.
Who is required to file expiration dating extensionfda?
Manufacturers or distributors of FDA approved products are required to file expiration dating extensionfda.
How to fill out expiration dating extensionfda?
To fill out expiration dating extensionfda, manufacturers or distributors must provide updated information on the product and justification for extending the expiration date.
What is the purpose of expiration dating extensionfda?
The purpose of expiration dating extensionfda is to ensure the safety and effectiveness of FDA approved products beyond their original expiration date.
What information must be reported on expiration dating extensionfda?
The information that must be reported on expiration dating extensionfda includes updated stability data, test results, and justification for extending the expiration date.
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