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# ANDA Amendments for Tentatively Approvals
- URL: https://www.fdaweb.com/anda-amendments-for-tentatively-approvals/
- Published: 2020-09-28T12:00:00.000Z
- Updated: 2026-09-14T16:30:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147742

FDA has issued a guidance entitled [*ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs*](https://u7061146.ct.sendgrid.net/ls/click?upn=4tNED-2FM8iDZJQyQ53jATUURzbOiTj4rjf8eQ-2FYEfOQ5THSul0bFGo4FhyR4b-2BPkN6tXfIb03jEQfD9nEWL3f97KHcaOOQ7u-2FaCjWJGOMNseOmO8gEl6SYs-2FDXcI1vvll98MimjFL8CeBXKlTveebYHU3ufmS6atjXDwIIroZjnRTmbf5vEXJIoUVMSqXoDaMF2dXqM2oNgS0cTUc-2FKqNcDi-2BJ0HrSUH3Z24l2Q1-2FegcFrooTlgyZybx2cVJAlUnTCdY1oRNJNpjRf1LdH5nACoOiHwQ6rb2C14j-2FQJo5VqyA8nYEPx7jTNtXo99TcOx3CV3g-2B3VNy0uMjiRxgxmiKC5w5VnsjFFCmEjFI0RRqwgf4vXUZBzDma9W7v1H1oX3PG50h30Y03KqnBHMEXFJwQ0tWB2CDEw3ja6x0HFHzj4sAE-2BZ1gdo92ZRDndF1PHd1LmTjkqSGRsKQarzgEHN8V-2FyNXULPwGViu03y8jvWq1TXgmr-2BW8C3aI3R8MLtLSx8-2Bhqhe2mlCoghNC3CSj7-2BvV5tu8jhMubige2tqPmyVdlwMjBo5G2mIqn7mFIDgOPCL79APUntwi3s4ekXAKFHiJXxmw3ZZKXTlhgC8C3RqS-2BdrKNRApvTBrFQRtrp6zvZmox0KWh7JCGoaD9Rhu24Q-3D-3DAUQX%5Ff0D7hj0BJ4b-2F7NuVqzPDs7FGiq8VLIwAX0sPSotqoLIZH-2BlHUpIN1Fpx16wXLzBItZQB-2B865N-2BRM-2FfR3UV9b-2B3x5yDeI-2BTg-2FGBCQMWf44N9W3Sq6Ij4qdENy55b9vdtshV-2F9q0RpeVIwNJGbbQBEfMrNvV3n0Mosm5Yh-2BCmO7cnvNNhunhcO2j64uMZHC03pxdlGqRa1LPysBUjRV9TfF0NgUwQsmQF1NAvqiUd274Y93wqtqFWhyN9TbjIm5tc-2BD6eHdJg-2BkdRJNGuIibqSVvfyQNhAb7GO1Noi1669-2BU9Wygy0H7ILd2FsrMhsGOOvnIx4ffTMpC5LatZor3OyRIAFD9dkThvPwCkfvFzhsYM-3D&ref=fdaweb.com). The document is intended to assist applicants in preparing and submitting amendments to tentatively approved ANDAs, including requests for final approval. It also provides recommendations on the timing and content of amendments to tentatively approved ANDAs to allow timely submissions that can result in final approvals on the earliest lawful approval date.  
  
FDA notes in the guidance that an ANDA applicant may submit amendments to a tentatively approved application that propose changes to the application or request final approval. As described in the guidance, a delay in submitting an amendment, or submitting an amendment that contains changes, could result in FDA’s final approval being delayed.