§803.50. If I am a manufacturer, what reporting requirements apply to me? — Inbound Citations

Abbreviated new drug application (ANDA) has the same meaning given the term “abbreviated application” in § 314.3(b) of this chapter.

(1) Report to FDA in accordance with §§ 803.50, 803.52, 803.53, and 803.56;

You must include the following information in your reports, if known or reasonably known to you, as described in § 803.50(b). These types of information correspond generally to the format of Form FDA 3500A: