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ANDA > Summary

An Abbreviated New Drug Application (ANDA) is an application for a U.S. generic drug approval for an existing licensed medication or approved drug. The ANDA is submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, which provides for the review and ultimate approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public. Electronic submissions of ANDAs have grown by 70% since November 2008. The Section IV challenge has been credited with suppressing new drug innovation.
I would like to know that how can we estimate ANDA filling date. I know its tricky thing but is it possible to find ANDA filling date without primay research? ... Read More »
Yali FriedmanBindu, I put together a slideshare explaining how to estimate ANDA entry dates at . In a nutshell, you have to identify the dominant patents and then figure out the patent expiration dates and any other regulatory exclusivities. My site at is designed to help with such research.
Oct 5, 2016