Complete response letters
FDA's letters telling drug and biologic applicants why an application was not approved as submitted. 458 records; openFDA updated it 2026-09-23. About this dataset
Newest records
FDA did not answer.
- Approved309
- Unapproved149
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.