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What is FDA new drug application?

New Drug Application (NDA) is a type of application in which a pharmaceutical manufacturer or its agent requests permission from the U.S. Food and Drug Administration (FDA) for a license to market a drug for one or more specified indications.

What is the FDA supplemental new drug application?

Compilation of information on the safety and efficacy of a marketed drug that is submitted to the FDA in order to request approval to market the drug for another indication.

What is a supplement to a new drug submission?

Supplement to a New Drug Submission (SNDS) is a supplement application submitted to Health Canada to notify changes that have substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of a drug product.

What is a supplemental new drug application?

sNDAs are typically submitted when a pharmaceutical company wants to make changes to an approved drug, such as: Expanding the approved indications (new uses) of the drug. Modifying the recommended dosage or administration regimen.

What is the FDA drug listing number?

NDC Number Each listed drug product listed is assigned a unique 10-digit, 3-segment number. This number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA.

What do NDC numbers mean?

The Electronic Orange Book (EOB) Query enables searching of the approved drug list by active ingredient, proprietary name, applicant holder, applicant number or patent. The Approved Drug Products EOB Query web files are downloadable.

What is the aim of the new drug application?

The goals of the NDA are to provide enough information to permit FDA reviewer to reach the following key decisions: Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks.

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