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Clinical Pharmacology Review PRODUCT (Generic Name): NDAs: 21476/S0045 SUBMISSION DATE 4/10/2012 PRODUCT (Brand Name): DOSAGE FORM: Tablet DOSAGE STRENGTHS: 1 mg, 2 mg, and 3 mg INDICATION: Treatment

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What is product generic name?

Product generic name refers to a name or term that identifies a product or substance in a specific category.

Who is required to file product generic name?

Manufacturers or distributors of products are typically required to file the product generic name.

How to fill out product generic name?

To fill out the product generic name, you need to provide the name that accurately represents the category and nature of the product.

What is the purpose of product generic name?

The purpose of product generic name is to provide a standardized way of identifying products and substances in a category.

What information must be reported on product generic name?

The product generic name should include information such as the category of the product or substance, and its key characteristics.

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