federal_register: 2026-03213
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2026-03213 | Determination That TOLECTIN DS (Tolmetin Sodium) Capsule, Equivalent to 400 Milligrams Base, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness | Notice | The Food and Drug Administration (FDA, Agency, or we) has determined that TOLECTIN DS (tolmetin sodium) capsule, equivalent to (EQ) 400 milligrams (mg) base, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for tolmetin sodium, capsule, EQ 400 mg base, if all other legal and regulatory requirements are met. | 2026-02-18 | 2026 | 2 | https://www.federalregister.gov/documents/2026/02/18/2026-03213/determination-that-tolectin-ds-tolmetin-sodium-capsule-equivalent-to-400-milligrams-base-was-not | https://www.govinfo.gov/content/pkg/FR-2026-02-18/pdf/2026-03213.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA, Agency, or we) has determined that TOLECTIN DS (tolmetin sodium) capsule, equivalent to (EQ) 400 milligrams (mg) base, was not withdrawn from sale for reasons of safety or effectiveness. This determination will... |