21 CFR 514.120 : Food And Drugs (§ 1.1 To Parts 1403-1499) — (Subpart A To Parts 590-599) — Food And Drug Administration, Department Of Health And Human Services (Continued) (Subpart A To Parts 590-599) — Animal Drugs, Feeds, And Related Products (Subpart A To Parts 590-599) — New Animal Drug Applications (§ 514.1 To § 514.235) — Administrative Actions On Applications (§ 514.80 To § 514.121) — Revocation of order refusing to approve an application or suspending or withdrawing approval of an application.

4 Aug 2016

The Commissioner, upon his own initiative or upon request of an applicant stating reasonable grounds therefor and if he finds that the facts so require, may issue an order approving an application that previously has had its approval refused, suspended, or withdrawn.

21 CFR 514.120