{"abstract":"The Food and Drug Administration (FDA) has determined that DIFFERIN (adapalene) solution, 0.1% (NDA 20-338), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for adapalene solution, 0.1%, 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/2013/01/31/2013-02087.html","cfr_references":[],"citation":"78 FR 6823","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2012-P-0916"],"dockets":[],"document_number":"2013-02087","effective_on":null,"end_page":6823,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2013/01/31/2013-02087.xml","html_url":"https://www.federalregister.gov/documents/2013/01/31/2013-02087/determination-that-differin-adapalene-solution-01-was-not-withdrawn-from-sale-for-reasons-of-safety","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2013-02087?publication_date=2013-01-31","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2013-01-31/2013-02087/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":1013,"last_updated":"2026-04-03 22:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-01-31/pdf/2013-02087.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-02087.pdf?1359554621","publication_date":"2013-01-31","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2013/01/31/2013-02087.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2012-P-0916","supporting_documents_count":0,"docket_id":"FDA-2012-P-0916","regulation_id_number":null,"title":"Determine That Adapalene Solution 0.1% is Suitable for Submission in an Abbreviated New Drug Application (ANDA)-CLOSED","checked_regulationsdotgov_at":"2013-02-20T08:05:09Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":6823,"subtype":null,"title":"Determination That DIFFERIN (Adapalene) Solution, 0.1%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness","toc_doc":"DIFFERIN (Adapalene)","toc_subject":"Determinations That Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness:","topics":[],"type":"Notice","volume":78}