federal_register: 2023-27661
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
This data as json
| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2023-27661 | Hoffmann-La Roche, Inc., et al.; Withdrawal of Approval of Two New Drug Applications | Notice | The Food and Drug Administration (FDA or the Agency) is withdrawing approval of two new drug applications (NDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. | 2023-12-18 | 2023 | 12 | https://www.federalregister.gov/documents/2023/12/18/2023-27661/hoffmann-la-roche-inc-et-al-withdrawal-of-approval-of-two-new-drug-applications | https://www.govinfo.gov/content/pkg/FR-2023-12-18/pdf/2023-27661.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA or the Agency) is withdrawing approval of two new drug applications (NDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that... |