RLD

RLD: An RLD is the specific listed drug on which an ANDA applicant relies in seeking approval for its ANDA. The ANDA applicant must show, among other things, that its proposed generic drug is the same as to the RLD with respect to the active ingredient(s), dosage form, route of administration, strength, labeling and conditions…

Innovator An innovator in the context of drugs refers to the original developer or manufacturer of a new pharmaceutical product.  – Example: Astellas is the innovator of Veozah, as they researched, developed, and brought the drug to market first.   Generic Drug Generic drugs are generic versions of a pharmaceutical product that are approved as…