{"abstract":"The Food and Drug Administration (FDA or Agency) has determined that GLUCOTROL (glipizide) tablets, 5 milligrams (mg) and 10 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to these products as long as they meet relevant legal and regulatory requirements.","action":"Notice.","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/2024/04/05/2024-07268.html","cfr_references":[],"citation":"89 FR 24011","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2024-P-0105"],"dockets":[{"supporting_documents":[{"title":"Attachment-III U_S_ Agent Authorization Letter","document_id":"FDA-2024-P-0105-0005"},{"title":"Attachment-II Controlled Correspondence Response","document_id":"FDA-2024-P-0105-0004"},{"title":"Attachment-I Orangebook databse","document_id":"FDA-2024-P-0105-0003"}],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2024-04-05","updated_at":"2024-09-03T16:51:39.447-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2024-P-0105-0006","allow_late_comments":false,"id":"FDA-2024-P-0105-0006","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":3,"id":"FDA-2024-P-0105","title":"Requests that the FDA determine whether Glucotrol glipizide Tablets, 5 mg and 10 mg, approved under New Drug Application NDA number 017783 held by Pfizer Inc., has been not discontinued or withdrawn for safety or effectiveness reasons"}],"document_number":"2024-07268","effective_on":null,"end_page":24011,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/04/05/2024-07268.xml","html_url":"https://www.federalregister.gov/documents/2024/04/05/2024-07268/determination-that-glucotrol-glipizide-tablets-5-milligrams-and-10-milligrams-were-not-withdrawn","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-07268?publication_date=2024-04-05","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-04-05/2024-07268/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":1002,"last_updated":"2026-04-04 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-04-05/pdf/2024-07268.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-07268.pdf?1712234726","publication_date":"2024-04-05","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/04/05/2024-07268.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Attachment-III U_S_ Agent Authorization Letter","document_id":"FDA-2024-P-0105-0005"},{"title":"Attachment-II Controlled Correspondence Response","document_id":"FDA-2024-P-0105-0004"},{"title":"Attachment-I Orangebook databse","document_id":"FDA-2024-P-0105-0003"}],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2024-P-0105","supporting_documents_count":3,"docket_id":"FDA-2024-P-0105","document_id":"FDA-2024-P-0105-0006","regulation_id_number":null,"title":"Requests that the FDA determine whether Glucotrol glipizide Tablets, 5 mg and 10 mg, approved under New Drug Application NDA number 017783 held by Pfizer Inc., has been not discontinued or withdrawn for safety or effectiveness reasons","checked_regulationsdotgov_at":"2024-04-06T14:00:09Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":24011,"subtype":null,"title":"Determination That GLUCOTROL (Glipizide) Tablets, 5 Milligrams and 10 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness","toc_doc":"Glucotrol (Glipizide) Tablets, 5 Milligrams and 10 Milligrams","toc_subject":"Drug Products not Withdrawn From Sale for Reasons of Safety or Effectiveness:\n","topics":[],"type":"Notice","volume":89}