The purpose of this list is to assist applicants submitting an ANDA to seek approval of a generic drug in identifying an RLD when an ANDA RS has been selected.

A Reference Listed Drug (RLD), as goes by its innate meaning, is an FDA approved drug product which can be referred to by a generic drug manufacturer while ...

A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. The RLD is identified ...

A Reference Listed Drug (RLD) is defined as the first drug approved for marketing in China and/or abroad and that is supported by complete and sufficient ...

The listed drug identified by FDA as the drug product upon which an applicant relies in seeking approval of its abbreviated application.

RLDs (Reference Listed Drugs) are brand-name medications that have been authorized by regulatory agencies. They serve as the standard for generic drug makers, ...

Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent.

28 окт. 2020 г. · The purpose of this guidance is to provide information to potential applicants on how to identify a reference listed drug (RLD), a reference standard, and the ...

16 янв. 2017 г. · A reference listed drug (RLD) is the listed drug to which the ANDA applicant must show its proposed generic drug is the same with respect to ...