What is an ANDA? The ANDA pathway is the process used to obtain approval to market a generic drug in the United States. Unlike an NDA Sponsor, an ANDA applicant is not required to demonstrate the safety and effectiveness of the drug for the conditions of use for which they are seeking approval of. Instead, the applicant must identify the reference listed drug (RLD) and relay that “FDA’s finding that the RLD relied upon by the ANDA applicant is safe and effective”. Sponsors must also include sufficient information “(1) to demonstrate that the proposed product is bioequivalent to the RLD5 and (2) to ensure the product’s identity, strength, quality, and purity”. Tentative Approval Meaning Tentative approval (also known as “TA”) is a notification granted by the FDA if an ANDA meets the substantive requirements for approval, but cannot obtain final approval for marketing due to unexpired patents or exclusivities. A grant of tentative approval does not mean the drug is approved, it