Abbreviated New Drug Application (ANDA) | Drug Regulatory Affairs

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.
----------------------------------------------------------------------------------------------------------------------
orange book:
• what is orange book?
hatch waxman act:
• HATCH WAXMAN ACT
----------------------------------------------------------------------------------------------------------------------
#PharmaLearn

[@SarathSasidharan-qs8by]

@Pharma Learn thanks a lot for the wonderful video on ANDA

[@byrisettineelima7351]

Super presentation and explanation mam.. Thank you so much for a wonderful vedio of info... Please do some more vedios mam

[@pharmalearn9407]

Sure 👍

[@insane3620]

Awesome and thanks

[@SarathSasidharan-qs8by]

@Pharma Learn - Can you please share the presentation to us if possible

[@vishaldeshmukh6435]

Great

[@shunmugaselvi1393]

Very easy to understand. 📒📒📒

[@pharmalearn9407]

Keep watching