This guidance is intended to assist applicants and holders of an abbreviated new drug application (ANDA) in updating their labeling following revisions to the approved labeling of a reference listed drug (RLD).
An RLD “is the listed drug identified by FDA as the drug product upon which an applicant relies in seeking approval of its ANDA”
An ANDA is an application submitted and approved under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for a drug product that is a duplicate of a previously approved drug product. An ANDA relies on FDA’s finding that the previously approved drug product—i.e., the RLD—is safe and effective.
An ANDA generally must contain information to show that the proposed generic product:
is the same as the RLD with respect to the active ingredient(s), conditions of use, route of administration, dosage form, strength, and labeling (with certain permissible differences); and
is bioequivalent to the RLD
This guidance provides recommendations on identifying RLD labeling updates and submitting ANDA amendments or supplements to update generic drug labeling.
Check out this guidance that includes updates on how to obtain information on changes to RLD labeling and how to submit revised ANDA labeling to FDA.
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