federal_register: 2026-06911
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 | regulation_id_numbers |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2026-06911 | GlaxoSmithKline; Withdrawal of Approval of a New Drug Application for Wellcovorin (Leucovorin Calcium) Tablets, EQ 5 mg Base and EQ 25 mg Base | Notice | The Food and Drug Administration (FDA or Agency) is withdrawing approval of a new drug application (NDA) for Wellcovorin (leucovorin calcium) tablets, EQ 5 mg base and EQ 25 mg base, held by GlaxoSmithKline, LLC, 2020 Walnut Street, Philadelphia, PA 19104 (GSK). GSK notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. | 2026-04-10 | 2026 | 4 | https://www.federalregister.gov/documents/2026/04/10/2026-06911/glaxosmithkline-withdrawal-of-approval-of-a-new-drug-application-for-wellcovorin-leucovorin-calcium | https://www.govinfo.gov/content/pkg/FR-2026-04-10/pdf/2026-06911.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA or Agency) is withdrawing approval of a new drug application (NDA) for Wellcovorin (leucovorin calcium) tablets, EQ 5 mg base and EQ 25 mg base, held by GlaxoSmithKline, LLC, 2020 Walnut Street, Philadelphia, PA... |