federal_register: 01-5610
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 01-5610 | Guidance for Industry on Levothyroxine Sodium Tablets-In Vivo Pharmacokinetic and Bioavailability Studies and In Vitro Dissolution Testing; Availability | Notice | The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Levothyroxine Sodium Tablets--In Vivo Pharmacokinetic and Bioavailability Studies and In Vitro Dissolution Testing." This guidance is intended to assist sponsors of new drug applications (NDA's) for levothyroxine sodium tablets who wish to conduct in vivo pharmacokinetic and bioavailability studies and in vitro dissolution testing for their products. | 2001-03-08 | 2001 | 3 | https://www.federalregister.gov/documents/2001/03/08/01-5610/guidance-for-industry-on-levothyroxine-sodium-tablets-in-vivo-pharmacokinetic-and-bioavailability | https://www.govinfo.gov/content/pkg/FR-2001-03-08/pdf/01-5610.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Levothyroxine Sodium Tablets--In Vivo Pharmacokinetic and Bioavailability Studies and In Vitro Dissolution Testing." This guidance is intended to... |