CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS (parts 500 to 590) > PART 514—NEW ANIMAL DRUG APPLICATIONS > SUBPART B—Administrative Actions on Applications (§514.80 to §514.121) > 514.120—Revocation of order refusing to approve an application or suspending or withdrawing approval of an application.

514.120—Revocation of order refusing to approve an application or suspending or withdrawing approval of an application.

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so require, may issue an order approving an application that previously has had its approval refused, suspended, or withdrawn.