An ANDA is a request to the Food and Drug Administration (FDA) to manufacture and market a generic drug in the United States.
The ANDA does not require the applicant to conduct clinical trials.
An ANDA-approved drug must be bioequivalent to the brand-name drug.
If an ANDA is approved, it is listed in the Orange Book as an FDA-approved medicine.
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orange book:
• what is orange book?
hatch waxman act:
• HATCH WAXMAN ACT
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