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21 U.S. Code § 379j-11. Definitions
For purposes of this subpart:(1)
(A) The term “animal drug application” means—
(i)
an application for approval of any new animal drug submitted under section 360b(b)(1) of this title; or
(ii)
an application for conditional approval of a new animal drug submitted under section 360ccc of this title.
(B)
Such term does not include either a new animal drug application submitted under section 360b(b)(2) of this title or a supplemental animal drug application.
(2) The term “supplemental animal drug application” means—
(A)
a request to the Secretary to approve a change in an animal drug application which has been approved; or
(B)
a request to the Secretary to approve a change to an application approved under section 360b(c)(2) of this title for which data with respect to safety or effectiveness are required.
(3)
The term “animal drug product” means each specific strength or potency of a particular active ingredient or ingredients in final dosage form marketed by a particular manufacturer or distributor, which is uniquely identified by the labeler code and product code portions of the National Drug Code, and for which an animal drug application or a supplemental animal drug application has been approved.
(4)
The term “animal drug establishment” means a foreign or domestic place of business which is at one general physical location consisting of one or more buildings all of which are within 5 miles of each other, at which one or more animal drug products are manufactured in final dosage form.