Health and Human Services Department, Food and Drug Administration
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document announced the withdrawal of approval of 11 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of March 23, 2026.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 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Masuu Global Solutions LLC, U.S. Agent for Extrovis AG, informed FDA that they did not want the approval of the ANDAs withdrawn. Because Masuu Global Solutions LLC, U.S. Agent for Extrovis AG, timely requested that approval of their ANDAs not be withdrawn, the approvals are still in effect.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.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2026-N-1224] 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document announced the withdrawal of approval of 11 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of March 23, 2026.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, Febru…
Other Federal Register documents from the same docket.
Citation: 91 FR 36145
