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Page 1 3PR00382×Application No. OH0134732 Issue Date: October 21, 2019, Effective Date: December 1, 2019, Expiration Date: November 30, 2024 Ohio Environmental Protection Agency Authorization to
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To fill out expiration dating extensionfdaexpiration dating, follow these steps:
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Gather all the relevant information about the product or substance that needs the expiration dating extension.
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Understand the guidelines and regulations set by the FDA for expiration dating.
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Determine the reason for the extension and gather supporting documentation or evidence.
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Prepare a formal request or application for the expiration dating extension, including all necessary forms and attachments.
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Submit the application to the FDA, following their specified submission process.
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Await response and follow up with any additional information or requests from the FDA.
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If approved, update the product or substance labeling to reflect the new expiration date.
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- Any entity that produces and distributes products or substances regulated by the FDA and requires an extension to the original expiration date.
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What is expiration dating extensionfdaexpiration dating?
Expiration dating extensionfdaexpiration dating refers to the process of extending the expiration date of a product approved by the FDA.
Who is required to file expiration dating extensionfdaexpiration dating?
Manufacturers and distributors of FDA-approved products are required to file expiration dating extensionfdaexpiration dating.
How to fill out expiration dating extensionfdaexpiration dating?
To fill out expiration dating extensionfdaexpiration dating, the manufacturer or distributor must submit a request to the FDA with relevant documentation supporting the extension.
What is the purpose of expiration dating extensionfdaexpiration dating?
The purpose of expiration dating extensionfdaexpiration dating is to ensure the continued safety and efficacy of FDA-approved products beyond their original expiration date.
What information must be reported on expiration dating extensionfdaexpiration dating?
The report for expiration dating extensionfdaexpiration dating must include data on stability testing, new expiration date proposed, and justification for the extension.
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