; or (2) notify the Secretary that the holder of the approved application does not agree that the requested modifications are warranted and submit a statement detailing the reasons why such modifications are not warranted. (f) Review of application holder's response (1) In general The Secretary shall promptly review each statement received under subsection (e)(2) and determine which modifications to the Secretary's notice under subsection (d) are appropriate, if any. (2) Changes to labeling After considering a response from a holder of an approved application under paragraph (1) or (2) of subsection (e), the Secretary may order such holder to make the labeling changes the Secretary determines are appropriate. Such holder of an approved application shall— (A) update its paper labeling for the drug at the next printing of that labeling; (B) update any electronic labeling for the drug within 30 days; and (C) submit the revised labeling through the form, Supplement—Changes Being Effected . (g) Violation If the holder of an approved application for the generic version of the selected drug does not comply with the requirements of subsection (f), such generic version of the selected drug shall be deemed to be misbranded under section 502. (h) Limitations