federal_register: 2024-31360
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2024-31360 | Flamingo Pharmaceuticals Ltd.; Withdrawal of Approval of Two Abbreviated New Drug Applications | Notice | The Food and Drug Administration (FDA or Agency) is withdrawing approval of two abbreviated new drug applications (ANDAs) from the holder of those ANDAs. The basis for the withdrawal is that the ANDA holder has repeatedly failed to file required annual reports for those ANDAs. | 2024-12-31 | 2024 | 12 | https://www.federalregister.gov/documents/2024/12/31/2024-31360/flamingo-pharmaceuticals-ltd-withdrawal-of-approval-of-two-abbreviated-new-drug-applications | https://www.govinfo.gov/content/pkg/FR-2024-12-31/pdf/2024-31360.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA or Agency) is withdrawing approval of two abbreviated new drug applications (ANDAs) from the holder of those ANDAs. The basis for the withdrawal is that the ANDA holder has repeatedly failed to file required annual... |