An abbreviated new drug application (ANDA) contains data which is submitted to FDA for the review and potential approval of a generic drug product.

What is difference between NDA and ANDA?

NDA means a New Drug Application. … If the NDA is approved, then the product may be marketed in the United States. ANDA means Abbreviated New Drug Application. An abbreviated new drug application (ANDA) contains data that, when submitted to the FDA, provides for the review and ultimate approval of a generic drug product.

What is included in an ANDA?

ANDA Specifications An ANDA lists the new drug’s established name, trade name (if any), chemical name, dosage form(s), and strength(s), route of administration, and proposed use. The ANDA asks for the name of the listed drug product to which the proposed generic is an equivalent.