DRUG DISCOVERY DEVELOPMENT (DDD): Abbreviated New Drug Application (ANDA)

__ may be issued if approval of the
generic drug occurs prior to the expiration dates of
patents or exclusivities of the reference drug

Question

Abbreviated New Drug Application (ANDA)

__ may be issued if approval of the
generic drug occurs prior to the expiration dates of
patents or exclusivities of the reference drug

LEIGHTON DWIGHT OBILLOS · Accepted Answer

Tentative Approval Letter delaying the marketing of
the generic product

Abbreviated New Drug Application (ANDA) __ may be issued if approval of the generic drug occurs prior to the expiration dates of patents or exclusivities of the reference drug