> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Guide on NDA/ANDA Marketing Status Notifications
- URL: https://www.fdaweb.com/guide-on-nda-anda-marketing-status-notifications/
- Published: 2020-08-10T12:00:00.000Z
- Updated: 2026-09-14T16:24:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147393

FDA has made available a guidance entitled [*Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format.*](https://u7061146.ct.sendgrid.net/ls/click?upn=LHDupLGQbJrIBf0glmWFG56-2F5cjxsvy-2BRYfSGVpJePD7HtQ-2FDW20Nz0QZZNd-2FDHb71LGszr6P47fO0iyseBE9PpBCam3efmr5L8pvTjuLIO-2BClMF67vCaPKdx-2FRKqWipLnv1NVXFtg1dJZ1DzT0vmZc2MoQuJ0eFQI5djeEuC7wZdHi8ZFZO-2BTAk-2Fm39iwRPlT8Bp0OG3rQv9Ys6rhE5ZY7rJQL85ry3Q90HbPiIJsbh9UpHRiaH4uPK42ZGMuYO24K1p2m6enA2bI8HwuuSwEN-2Boa4vKgLNALyoR5lFi5MFi5h-2BWbbqCmhmCvSMSVwjtO-2FnWecRDceQZkJYPhiKGg-3D-3DT-i7%5Ff0D7hj0BJ4b-2F7NuVqzPDs7FGiq8VLIwAX0sPSotqoLIZH-2BlHUpIN1Fpx16wXLzBItZQB-2B865N-2BRM-2FfR3UV9b-2B3x5yDeI-2BTg-2FGBCQMWf44N-2BnLeApYLGuoeBS83Hw9Ypi6KmPAzorKFN-2BzBExH4s9jRgnoH8-2B6QDDFU1xbWYDnf9h94AwS-2FRzFHk0iK8quR7S-2BxG4GMyssKugIkiDNUyPVZtxVQF7Hy5pw-2Fny5QB-2BYizwf0QOC-2FIQHzYfglKNF56JC06-2BJ44unZg1euHB6JIH6qzop98cXXGjsQAERvcXjQ2guXtunkkPnv5HiMj5VqYntvCJvm6tfdG-2FR0l3aQ2spCSI-2FuuGiZdAsfKNUb35aBY-3D&ref=fdaweb.com) It advises NDA/ANDA holders to provide a written notification to FDA 180 days prior to withdrawing an approved drug from sale. It also asks them to provide a written notification if a drug will not be available for sale within 180 days of the date of approval. Additionally, the guidance recommends content for the marketing status notifications, the format for submitting them, and the timelines for submission.