Masuu Global Solutions LLC, U.S. Agent for Extrovis AG, et al.; Withdrawal of Approval of 11 Abbreviated New Drug Applications; Correction

This site displays a prototype of a “Web 2.0” version of the daily Federal Register. It is not an official legal edition of the Federal Register, and does not replace the official print version or the official electronic version on GPO’s govinfo.gov. The documents posted on this site are XML renditions of published Federal Register documents. Each document posted on the site includes a link to the corresponding official PDF file on govinfo.gov. This prototype edition of the daily Federal Register on FederalRegister.gov will remain an unofficial informational resource until the Administrative Committee of the Federal Register (ACFR) issues a regulation granting it official legal status. For complete information about, and access to, our official publications and services, go to About the Federal Register on NARA's archives.gov. The OFR/GPO partnership is committed to presenting accurate and reliable regulatory information on FederalRegister.gov with the objective of establishing the XML-based Federal Register as an ACFR-sanctioned publication in the future. While every effort has been made to ensure that the material on FederalRegister.gov is accurately displayed, consistent with the official SGML-based PDF version on govinfo.gov, those relying on it for legal research should verify their results against an official edition of the Federal Register. Until the ACFR grants it official status, the XML rendition of the daily Federal Register on FederalRegister.gov does not provide legal notice to the public or judicial notice to the courts. Notice Enter a search term or FR citation e.g. 88 FR 38230 FR 78782024-13208USDA09/05/24RULE0503-AA39SORN Choosing an item from full text search results will bring you to those results. Pressing enter in the search box will also bring you to search results. Choosing an item from suggestions will bring you directly to the content. This table of contents is a navigational tool, processed from the headings within the legal text of Federal Register documents. This repetition of headings to form internal navigation links has no substantive legal effect. This PDF is FR Doc. 2026-12044 as it appeared on Public Inspection on 06/15/2026 at 8:45 am. It was viewed 20 times while on Public Inspection. If you are using public inspection listings for legal research, you should verify the contents of the documents against a final, official edition of the Federal Register. Only official editions of the Federal Register provide legal notice of publication to the public and judicial notice to the courts under 44 U.S.C. 1503 & 1507. Learn more here. Published Document: 2026-12044 (91 FR 36145) This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format. AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. SUMMARY: The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on February 20, 2026. The document announced the withdrawal of approval of 11 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of March 23, 2026. The document indicated that FDA was withdrawing approval of ANDAs 078022 for propranolol hydrochloride (HCl), extended-release capsule, 60 milligrams (mg), 80 mg, 120 mg, and 160 mg, and 090665 for lidocaine HCl, injectable, 2%, held by Masuu Global Solutions LLC, U.S. Agent for Extrovis ( printed page 36146) AG, 2255 Glades Rd., Suite 324A, Boca Raton, FL 33431. Before FDA withdrew the approval of these ANDAs, Masuu Global Solutions LLC, U.S. Agent for Extrovis AG, informed FDA that they did not want the approval of the ANDAs withdrawn. Because Masuu Global Solutions LLC, U.S. Agent for Extrovis AG, timely requested that approval of their ANDAs not be withdrawn, the approvals are still in effect. This notice corrects that error. FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 301-796-3471, Martha.Nguyen@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In the Federal Register of Friday, February 20, 2026 (91 FR 8242), appearing on page 8242 in FR Doc. 2026-03411, the following correction is made: On page 8243, in the table, the entries for ANDA 078022 and ANDA 090665 are removed. Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.