Issue Date: April 29, 2024
Issued by: Center for Drug Evaluation and Research
Topic(s): Electronic Submissions, Drug Competition Action Plan, Generic Drugs
Status: Draft
Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in NDAs and ANDAs
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Content and Format of Composition Statements in NDAs and ANDAs and Corresponding Statement of Ingredients in Labeling.” This guidance is intended to assist new drug application (NDA) and abbreviated new drug application (ANDA) applicants in submitting an accurate and complete composition statement in their applications and corresponding statement of ingredients in the labeling, when applicable. This guidance describes best practices for writing the composition statement and corresponding statement of ingredients in labeling. This guidance recommends how applicants can provide complete information with the goal of minimizing the number of assessment cycles and communications that are necessary for approval, as well as ensuring product labels are written clearly.
Download the Guidance Document
