federal_register: 00-10322
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 00-10322 | Prescription Drug Products; Levothyroxine Sodium; Extension of Compliance Date | Notice | The Food and Drug Administration (FDA) is announcing that manufacturers who were marketing orally administered drug products containing levothyroxine sodium on or before August 14, 1997, may continue to market these products without approved applications until August 14, 2001. FDA is extending by 1 year the compliance date given in the notice published in the Federal Register of August 14, 1997 (62 FR 43535). The agency is taking this action to give manufacturers additional time to conduct studies and to prepare applications. | 2000-04-26 | 2000 | 4 | https://www.federalregister.gov/documents/2000/04/26/00-10322/prescription-drug-products-levothyroxine-sodium-extension-of-compliance-date | https://www.govinfo.gov/content/pkg/FR-2000-04-26/pdf/00-10322.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing that manufacturers who were marketing orally administered drug products containing levothyroxine sodium on or before August 14, 1997, may continue to market these products without approved... |