term eligible component means— (i) an approved generic drug, (ii) a licensed biosimilar, and (iii) any drug substance, intermediate, raw material, starting material, reagent, component, in-process material, inactive ingredient, container closure system, packaging, quality testing, or other material or service used, or sold with intention for use, in the production of an approved generic drug or a licensed biosimilar. (B) Exclusion of certain components The term eligible component shall not include a component any portion of the production of which occurred at a facility which is the subject of a warning letter— (i) which was issued by the Food and Drug Administration on or after September 1, 2009, and (ii) with respect to which the Food and Drug Administration has not issued a close-out letter. (C) Application with other credits The term eligible component shall not include any property which is produced at a facility if the basis of any property which is part of such facility is taken into account for purposes of the credit allowed under section 48F after the date of the enactment of this section. (2) Approved generic drug The term approved generic drug means— (A) a drug for which an approval of an application filed under section 505(j) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j) ) is in effect, or (B) an authorized generic drug. (3) Authorized generic drug