Facilities that process raw materials used to manufacture human generic drugs are
generally required to self-identify if they supply any ingredient that is listed in an
ANDA and that ingredient appears in FDA’s Approved Drug Products with
Therapeutic Equivalence Evaluations (the Orange Book) as an active ingredient of
the drug covered by that ANDA. (Although the ANDA may not yet be approved,
the referenced listed drug for which the ANDA drug will be a generic copy will
appear in the Orange Book.)