It is a common misconception that the Hatch-Waxman Act of 1984 created the generic drug approval process in the US. A recent article claimed there were few generic drugs approved in the US before that act was passed.

In fact, the US Food and Drug Administration (FDA) approved many generic drugs before 1984, using three separate approval mechanisms: the Abbreviated New Drug Application (ANDA) for drugs originally approved before 1962; the “paper NDA,” a type of New Drug Application (NDA) for generic copies of drugs approved after 1962; and the monograph system for generic antibiotics and insulin.