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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...  

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