Abbreviated New Drug Application (ANDA)

An ANDA is an abbreviated version of New Drug Application (NDA). It is allowed for duplicates of drug products that were first approved before October 10, 1962 and for certain other drugs which are described in the CFR. Its main use is to obtain FDA approval for generic drugs.

More information about Abbreviated New Drug Application (ANDA)


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Gustave Roussy
Beyond Spring
Clinical Services
NS Pharma
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