Labeling Supplement

For NDAs, ANDAs, and BLAs, this represents a request to modify an existing label that do not rise to the level of an efficacy supplement for purposes such as adding additional safety information, clarification, etc. Labeling supplements may only be submitted once the original-application has been approved/licensed. (Food and Drug Administration)

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Labeling Activity

The action of affixing an identifier to an item or the container for an item.

Labeling

All written, printed, or graphic matter accompanying an article at any time while such article is in interstate commerce or held for…

Labeler Regulatory Contact for FDA

The representative of a labeler company who is the authorized channel for communication between the company and the FDA.

Labeled as Containing Natural Rubber Latex

The device label indicates natural rubber latex as a component.

Labeled

Bearing or marked with a label or tag.

Label Type Flag

An indicator that specifies if the classification scheme is A= alphanumeric; C=character; N=numeric.