{"abstract":"The Food and Drug Administration (FDA or Agency) has determined that K-TAB (potassium chloride) extended-release tablets, 10 milliequivalents and 20 milliequivalents, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for potassium chloride extended-release tablets, 10 milliequivalents (meqs) and 20 meqs, if all other legal and regulatory requirements are met.","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/2023/08/03/2023-16537.html","cfr_references":[],"citation":"88 FR 51324","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2023-P-2339"],"dockets":[{"supporting_documents":[{"title":"Annexure III - Copy of Agency’s Response to Controlled Correspondence Control No. 00158625 K-TAB\n(Potassium Chloride) Extended Release Tablets 10 mEq and 20 mEq where FDA suggested the\napplicant that any abbreviated new drug application (ANDA) submitted that refers to NDA RE Citizen Petition from Granules India Limited","document_id":"FDA-2023-P-2339-0005"},{"title":"Annexure II - Copy of Controlled Correspondence Control No. 00158625 for of K-TAB (Potassium Chloride) Extended Release Tablets 10 mEq and 20 mEq requesting RS designation by Granules India Limited RE Citizen Petition from Granules India Limited","document_id":"FDA-2023-P-2339-0004"},{"title":"Annexure I - Copy of Orange Book data, listing the discontinuation of K-TAB (Potassium Chloride) Extended\nRelease Tablets 10 mEq and 20 mEq, NDA No. 018279 RE Citizen Petition from Granules India Limited","document_id":"FDA-2023-P-2339-0003"}],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":null,"updated_at":"2023-08-03T11:57:23.398-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2023-P-2339-0006","allow_late_comments":null,"id":"FDA-2023-P-2339-0006","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":3,"id":"FDA-2023-P-2339","title":"Request that the FDA determine whether K-TAB (Potassium Chloride) Extended Release Tablets 10 mEq and 20 mEq, NDA No. 018279, held by ABBVIE INC, was voluntarily withdrawn for reasons of safety or effectiveness and may be used as the Reference Listed Drug (RLD) and Basis of Submission for an Abbreviated New Drug Application (ANDA) for a generic version of this drug"}],"document_number":"2023-16537","effective_on":null,"end_page":51325,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/08/03/2023-16537.xml","html_url":"https://www.federalregister.gov/documents/2023/08/03/2023-16537/determination-that-k-tab-potassium-chloride-extended-release-tablets-10-milliequivalents-and-20","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2023-16537?publication_date=2023-08-03","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2023-08-03/2023-16537/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":641,"last_updated":"2026-04-03 22:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-08-03/pdf/2023-16537.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-16537.pdf?1690980328","publication_date":"2023-08-03","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2023/08/03/2023-16537.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Annexure III - Copy of Agency’s Response to Controlled Correspondence Control No. 00158625 K-TAB\n(Potassium Chloride) Extended Release Tablets 10 mEq and 20 mEq where FDA suggested the\napplicant that any abbreviated new drug application (ANDA) submitted that refers to NDA RE Citizen Petition from Granules India Limited","document_id":"FDA-2023-P-2339-0005"},{"title":"Annexure II - Copy of Controlled Correspondence Control No. 00158625 for of K-TAB (Potassium Chloride) Extended Release Tablets 10 mEq and 20 mEq requesting RS designation by Granules India Limited RE Citizen Petition from Granules India Limited","document_id":"FDA-2023-P-2339-0004"},{"title":"Annexure I - Copy of Orange Book data, listing the discontinuation of K-TAB (Potassium Chloride) Extended\nRelease Tablets 10 mEq and 20 mEq, NDA No. 018279 RE Citizen Petition from Granules India Limited","document_id":"FDA-2023-P-2339-0003"}],"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-2023-P-2339","supporting_documents_count":3,"docket_id":"FDA-2023-P-2339","document_id":"FDA-2023-P-2339-0006","regulation_id_number":null,"title":"Request that the FDA determine whether K-TAB (Potassium Chloride) Extended Release Tablets 10 mEq and 20 mEq, NDA No. 018279, held by ABBVIE INC, was voluntarily withdrawn for reasons of safety or effectiveness and may be used as the Reference Listed Drug (RLD) and Basis of Submission for an Abbreviated New Drug Application (ANDA) for a generic version of this drug","checked_regulationsdotgov_at":"2023-08-04T15:00:10Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":51324,"subtype":null,"title":"Determination That K-TAB (Potassium Chloride) Extended-Release Tablets, 10 Milliequivalents and 20 Milliequivalents, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness","toc_doc":"K-Tab (Potassium Chloride) Extended-Release Tablets, 10 Milliequivalents and 20 Milliequivalents","toc_subject":"Drug Products not Withdrawn from Sale for Reasons of Safety or Effectiveness","topics":[],"type":"Notice","volume":88}