[Federal Register Volume 89, Number 51 (Thursday, March 14, 2024)]
[Notices]
[Page 18641]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-05426]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-5323]


Hoffmann-La Roche, Inc., et al.; Withdrawal of Approval of Two 
New Drug Applications; Correction

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 December 18, 2023. The 
document announced the withdrawal of approval of two new drug 
applications (NDA), withdrawn as of January 17, 2024. The document 
indicated that FDA was withdrawing approval of NDA 022424, FLOWTUSS 
(guaifenesin 200 milligrams (mg)/5 milliliters (mL) and hydrocodone 
bitartrate 2.5 mg/5 mL) Oral Solution held by Chartwell RX Sciences, 
LLC, 77 Brenner Dr., Congers, NY 10920. Before FDA withdrew the 
approval of this NDA, Chartwell RX Sciences, LLC informed FDA that it 
did not want the approval of the NDA withdrawn. Because Chartwell RX 
Sciences, LLC timely requested that approval of NDA 022424 not be 
withdrawn, the approval is still in effect. This notice corrects that 
error.

FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137, [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of Monday, December 
18, 2023 (88 FR 87433), appearing on page 87433 in FR Doc. 2023-27661, 
the following correction is made:
    On page 87433, in the table, the entry for NDA 022424 is removed.

    Dated: March 11, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-05426 Filed 3-13-24; 8:45 am]
BILLING CODE 4164-01-P