{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a revised draft guidance for industry on generic cyclobenzaprine hydrochloride extended release capsules, entitled \"Draft Guidance on Cyclobenzaprine Hydrochloride.\" The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for cyclobenzaprine hydrochloride extended release capsules.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2016/11/25/2016-28334.html","cfr_references":[],"citation":"81 FR 85229","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comments on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by January 24, 2017.","disposition_notes":null,"docket_ids":["Docket No. FDA-2007-D-0369"],"dockets":[],"document_number":"2016-28334","effective_on":null,"end_page":85231,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/11/25/2016-28334.xml","html_url":"https://www.federalregister.gov/documents/2016/11/25/2016-28334/bioequivalence-recommendations-for-cyclobenzaprine-hydrochloride-revised-draft-guidance-for-industry","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-28334?publication_date=2016-11-25","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-11-25/2016-28334/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":388,"last_updated":"2026-10-24 06:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-11-25/pdf/2016-28334.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-28334.pdf?1479908765","publication_date":"2016-11-25","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/11/25/2016-28334.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"PSG_212725 - Draft Guidance on Entrectinib re Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability","document_id":"FDA-2007-D-0369-0820"},{"title":"PSG_212477 - Draft Guidance on Ledipasvir; Sofosbuvir re Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability","document_id":"FDA-2007-D-0369-0818"},{"title":"PSG_212320 - Draft Guidance on Ferric Maltol re Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability","document_id":"FDA-2007-D-0369-0816"},{"title":"PSG_208612 - Draft Guidance on Ethinyl Estradiol; Levonorgestrel re Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability","document_id":"FDA-2007-D-0369-0805"},{"title":"PSG_206089 - Draft Guidance on Testosterone Undecanoate re Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability","document_id":"FDA-2007-D-0369-0802"},{"title":"PSG_022201 - Draft Guidance on Degarelix Acetate re Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability","document_id":"FDA-2007-D-0369-0797"},{"title":"PSG_212862 - Draft Guidance on Pretomanid","document_id":"FDA-2007-D-0369-0544"},{"title":"PSG_211635 - Draft Guidance on Diazepam","document_id":"FDA-2007-D-0369-0540"},{"title":"PSG_208910 - Draft Guidance on Vancomycin Hydrochloride","document_id":"FDA-2007-D-0369-0537"},{"title":"PSG_207071 - Draft Guidance on Azelaic Acid","document_id":"FDA-2007-D-0369-0533"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2007-D-0369","supporting_documents_count":111,"docket_id":"FDA-2007-D-0369","regulation_id_number":null,"title":"Industry Describing Product-Specific Bioequivalence Recommendations","checked_regulationsdotgov_at":"2017-01-25T05:00:49Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":85229,"subtype":null,"title":"Bioequivalence Recommendations for Cyclobenzaprine Hydrochloride; Revised Draft Guidance for Industry; Availability","toc_doc":"Bioequivalence Recommendations for Cyclobenzaprine Hydrochlorid","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":81}