Abbreviated New Drug Application (ANDA)
Definition
[21 U.S.C. § 505(j)] A document submitted by a drug manufacturer to the FDA for approval of a generic drug showing the drug operates in the same manner as its reference listed drug (RLD) but requiring a more limited set of information than that required for a New Drug Application.
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Mauris finibus odio eu maximus interdum. Ut ultricies suscipit justo in bibendum. Sed eu magna efficitur, luctus lorem ut, tincidunt arcu. Praesent varius sit amet erat hendrerit placerat. In posuere eget ante id facilisis. Integer semper venenatis felis lacinia malesuada.
Mauris finibus odio eu maximus interdum. Ut ultricies suscipit justo in bibendum. Sed eu magna efficitur, luctus lorem ut, tincidunt arcu. Praesent varius sit amet erat hendrerit placerat. In posuere eget ante id facilisis. Integer semper venenatis felis lacinia malesuada.
Mauris finibus odio eu maximus interdum. Ut ultricies suscipit justo in bibendum. Sed eu magna efficitur, luctus lorem ut, tincidunt arcu. Praesent varius sit amet erat hendrerit placerat. In posuere eget ante id facilisis. Integer semper venenatis felis lacinia malesuada.
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