Cover Letter Attachments for Controlled Correspondences and ANDA Submissions

Cover Letter Attachments for Controlled Correspondences and ANDA Submissions guidance is intended to assist prospective applicants, applicants, and holders of abbreviated new drug applications (ANDA) with optional attachments that can be used when preparing cover letters that accompany controlled correspondence to the Office of Generic Drugs (OGD), as well as original ANDAs, amendments to ANDAs, and supplements to approved ANDAs submitted to FDA. These attachments do not replace the recommendations for the content of cover letters provided in other FDA guidance’s.