federal_register: 2024-31023
This data as json
| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2024-31023 | Determination of Regulatory Review Period for Purposes of Patent Extension; XTAMPZA ER | Notice | The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for XTAMPZA ER and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product. | 2024-12-30 | 2024 | 12 | https://www.federalregister.gov/documents/2024/12/30/2024-31023/determination-of-regulatory-review-period-for-purposes-of-patent-extension-xtampza-er | https://www.govinfo.gov/content/pkg/FR-2024-12-30/pdf/2024-31023.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for XTAMPZA ER and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of... |