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[Federal Register Volume 89, Number 249 (Monday, December 30, 2024)]
[Notices]
[Page 106522]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31307]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-3248]

Fosun Pharma USA Inc., et al.; Withdrawal of Approval of 23 
Abbreviated New Drug Applications; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a notice 
that appeared in the Federal Register on July 29, 2024. The document 
announced the withdrawal of approval of 23 abbreviated new drug 
applications (ANDAs) from multiple applicants, withdrawn as of August 
28, 2024. The document indicated that FDA was withdrawing approval of 
the ANDAs 073462 for tolmetin sodium capsules, equivalent to (EQ) 400 
milligrams (mg) base; 073588 for tolmetin sodium tablets, EQ 200 mg 
base; 074002 for tolmetin sodium tablets, EQ 600 mg base; 077040 for 
citalopram hydrobromide tablets, EQ 10 mg base, EQ 20 mg base; EQ 40 mg 
base; 085787 for trifluoperazine hydrochloride (HCl) concentrate, EQ 10 
mg base/milliliters (mL); 086808 for cyproheptadine HCl tablets, 4 mg; 
087774 for phenylbutazone capsules, 100 mg; and 088602 for 
pseudoephedrine HCl; triprolidine HCl tablets, 60 mg/2.5.mg, held by 
Fosun Pharma USA Inc., 104 Carnegie Center, Suite 204, Princeton, NJ 
08540. Additionally, ANDAS 075631 for ketorolac tromethamine 
injectable, 15 mg/mL and 30 mg/mL; 076427 for milrinone lactate 
injectable, EQ 1 mg base/mL; 076791 for haloperidol lactate injectable, 
EQ 5 mg base/mL; 076828 haloperidol lactate injectable, EQ 5 mg base/
mL; 077947 for fluconazole injectable, 200 mg/100 mL (2 mg/mL) and 400 
mg/200 mL (2 mg/mL); 078197 for granisetron HCl injectable, EQ 0.1 mg 
base/mL (EQ 0.1 mg base/mL); 091436 for levofloxacin injectable, EQ 500 
mg/20 mL (EQ 25 mg/mL); 207101 for sumatriptan succinate injectable, EQ 
6 mg base/0.5 mL (EQ12 mg base/mL); and 215065 for methocarbamol 
solution, 1gram/10 mL (100 mg/mL), held by Baxter Healthcare Corp., One 
Baxter Parkway, Deerfield, IL 60015; and the ANDAs 090367 for 
levofloxacin tablets, 250 mg, 500 mg, 750 mg; and 211959 for clobazam 
tablets, 10 mg and 20 mg, held by Celltrion USA, Inc., U.S. Agent for 
Celltrion, Inc., One Evertrust Plaza, Suite 1207, Jersey City, NJ 
07302; and the ANDA 212053 for chlorzoxazone tablet, 375 mg and 750 mg, 
held by i3 Pharmaceuticals LLC, 200 Park Ave., Warminster, PA 18974. 
Before FDA withdrew the approval of these ANDAs, Fosun Pharma USA Inc.; 
Baxter Healthcare Corp.; Celltrion USA, Inc., U.S. Agent for Celltrion, 
Inc.; and i3 Pharmaceuticals LLC, 200 Park Ave., Warminster, PA 18974, 
informed FDA that they did not want the approval of the ANDAs 
withdrawn. Because Fosun Pharma USA Inc.; Baxter Healthcare Corp.; 
Celltrion USA, Inc., U.S. Agent for Celltrion, Inc.; and i3 
Pharmaceuticals, LLC, timely requested that approval of their 
respective ANDAs not be withdrawn, the approvals are still in effect. 
This notice corrects these errors.

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, [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of Monday, July 29, 
2024 (89 FR 60902), appearing on page 60902 in FR Doc. 2024-16627, the 
following correction is made:
    On page 60902, in the table, the entries for ANDA 073462, ANDA 
073588, ANDA 074002, ANDA 075631, ANDA 076427, ANDA 076791, ANDA 
076828, ANDA 077040, ANDA 077947, ANDA 078197, ANDA 085787, ANDA 
086808, ANDA 087774, ANDA 088602, ANDA 090367, ANDA 091436 ANDA 207101, 
ANDA 211959, ANDA 212053, and ANDA 215065 are removed.

    Dated: December 20, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-31307 Filed 12-27-24; 8:45 am]
BILLING CODE 4164-01-P
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