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Inactive Ingredient Database FDA Update Nazi Ya, Ph.D. Acting Director for Chemistry Division IV Office of Generic Drugs Food and Drug Administration The USP Recipients Stakeholder Forum June 18,20141Disclaimer

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What is inactive ingredient database?

The inactive ingredient database contains information on the inactive ingredients used in pharmaceutical products.

Who is required to file inactive ingredient database?

Pharmaceutical companies are required to file the inactive ingredient database.

How to fill out inactive ingredient database?

The inactive ingredient database can be filled out online through the designated platform provided by the regulatory authorities.

What is the purpose of inactive ingredient database?

The purpose of the inactive ingredient database is to ensure transparency and safety in pharmaceutical products.

What information must be reported on inactive ingredient database?

The database must include the names and quantities of inactive ingredients used in each pharmaceutical product.

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