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NDA 207795 Page 2CARTON AND IMMEDIATE CONTAINER LABELS Submit final printed carton and immediate container labels that are identical to the enclosed carton and immediate container labels as soon as

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What is carton and immediate container?

Carton is the outer packaging that contains multiple immediate containers. Immediate container is the main package that directly holds the product.

Who is required to file carton and immediate container?

Manufacturers, distributors, and importers are required to file carton and immediate container.

How to fill out carton and immediate container?

Carton and immediate container should be filled out with accurate information regarding the product, manufacturer, and packaging.

What is the purpose of carton and immediate container?

The purpose of carton and immediate container is to provide information about the product, its origin, and packaging to regulatory authorities and consumers.

What information must be reported on carton and immediate container?

Information such as product name, manufacturer's name and address, ingredients, batch number, and expiration date must be reported on carton and immediate container.

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