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# FDARA Marketing Status Report Request
- URL: https://www.fdaweb.com/fdara-marketing-status-report-request/
- Published: 2018-01-03T12:00:00.000Z
- Updated: 2026-09-14T23:10:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140410

FDA has published online instructions for NDA and ANDA holders to use in submitting a one-time marketing status report required by the FDA Reauthorization Act of 2017\. NDA and ANDA holders are to review information published in the *Orange Book* and submit a one-time report indicating that **(1)** the drugs listed in the *Orange Book* are available for sale or **(2)** one or more of the NDA or ANDA holder’s drugs listed in the book have been withdrawn from sale or have never been available for sale.

The [instructions](https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ApprovedDrugProductswithTherapeuticEquivalenceEvaluationsOrangeBook/ucm590216.htm?ref=fdaweb.com) tell NDA and ANDA holders how to submit reports for each of their drugs listed in the active section of the *Orange Book*.