4164-01-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-0020]
SpecGX, LLC, et al.; Withdrawal of Approval of 30 Abbreviated 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 March 29, 2024. The document announced the withdrawal of approval
of 30 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of
April 29, 2024. The document indicated that FDA was withdrawing approval of the following
ANDAs after receiving withdrawal requests from Target Health LLC, U.S. Agent for CASI
Pharmaceuticals, Inc., 450 Commerce Blvd., Carlstadt, NJ 07072: ANDA 076280, Tizanidine
Hydrochloride (HCl) Tablets, Equivalent to (EQ) 2 milligrams (mg) base and EQ 4 mg base;
ANDA 077021, Cilostazol Tablets, 100 mg; ANDA 077310, Cilostazol Tablets, 50 mg; ANDA
077517, Ondansetron HCl Tablets, EQ 4 mg base, EQ 8 mg base, and EQ 24 mg base; ANDA
206672, Entecavir Tablets, 0.5 mg and 1 mg; and ANDA 209550, Tenofovir Disoproxil
Fumarate Tablets, 300 mg. Before FDA withdrew the approval of these ANDAs, Target Health
LLC, informed FDA that it did not want the approval of the ANDAs withdrawn. Because Target
Health LLC, timely requested that approvals of ANDAs 076280, 077021, 077310, 077517,
206672, and 209550 not be withdrawn, the approvals are still in effect.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, March 29, 2024
(89 FR 22155), appearing on page 22155 in FR Doc. 2024-06730, the following correction is
made:
On page 22155, in the table, the entries for ANDAs 076280, 077021, 077310, 077517,
206672, and 209550 are removed.
Dated: June 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-13658 Filed: 6/20/2024 8:45 am; Publication Date: 6/21/2024]