2024-16627. Fosun Pharma USA Inc., et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications

Table 1—ANDAs for Which Approval Is Withdrawn

Application No.	Drug	Applicant
ANDA 073462	Tolmetin Sodium capsule, Equivalent to (EQ) 400 milligrams (mg) base	Fosun Pharma USA Inc., 104 Carnegie Center, Suite 204, Princeton, NJ 08540.
ANDA 073588	Tolmetin Sodium tablet, EQ 200 mg base	Do.
ANDA 074002	Tolmetin Sodium tablet, EQ 600 mg base	Do.
ANDA 075631	Ketorolac Tromethamine injectable, 15 mg/milliliters (mL) and 30 mg/mL	Baxter Healthcare Corp., One Baxter Parkway, Deerfield, IL 60015.
ANDA 076427	Milrinone Lactate injectable, EQ 1 mg base/mL	Do.
ANDA 076791	Haloperidol Lactate injectable, EQ 5 mg base/mL	Do.
ANDA 076828	Haloperidol Lactate injectable, EQ 5 mg base/mL	Do.
ANDA 077040	Citalopram Hydrobromide tablet, EQ 10 mg base, EQ 20 mg base, EQ 40 mg base	Fosun Pharma USA Inc.
ANDA 077947	Fluconazole injectable, 200 mg/100 mL (2 mg/mL) and 400 mg/200 mL (2 mg/mL)	Baxter Healthcare Corp.
ANDA 078197	Granisetron Hydrochloride (HCl) injectable, EQ 0.1 mg base/mL (EQ 0.1 mg base/mL)	Do.
ANDA 079045	Bicalutamide tablet, 50 mg	Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich, IL 60047.
ANDA 085787	Trifluoperazine HCl concentrate, EQ 10 mg base/mL	Fosun Pharma USA Inc.
ANDA 086808	Cyproheptadine HCl tablet, 4 mg	Do.
ANDA 087774	Phenylbutazone capsule, 100 mg	Do.
ANDA 088602	Pseudoephedrine HCl; Triprolidine HCl tablet, 60 mg; 2.5.mg	Do.
ANDA 090367	Levofloxacin tablet, 250 mg, 500 mg, 750 mg	Celltrion USA, Inc., U.S. Agent for Celltrion, Inc., One Evertrust Plaza, Suite 1207, Jersey City, NJ 07302.
ANDA 091049	Ceftriaxone Sodium injectable, EQ 250 mg base/vial, EQ 500 mg base/vial, EQ 1 gram (g) base/vial, EQ 2 g base/vial	EAS Consulting Group, LLC, U.S. Agent for Astral SteriTech Pvt. Ltd., 1700 Diagonal Rd., Suite 750, Alexandria, VA 22314.
ANDA 091436	Levofloxacin injectable, EQ 500 mg/20 mL (EQ 25 mg/mL)	Baxter Healthcare Corp.
ANDA 207032	Melphalan HCl injectable, EQ 50 mg base/vial	USWM, LLC, 4441 Springdale Rd., Louisville, KY 40241.
ANDA 207101	Sumatriptan Succinate injectable, EQ 6 mg base/0.5 mL (EQ 12 mg base/mL)	Baxter Healthcare Corp.
ANDA 211959	Clobazam tablet, 10 mg and 20 mg	Celltrion USA, Inc., U.S. Agent for Celltrion, Inc.
ANDA 212053	Chlorzoxazone tablet, 375 mg and 750 mg	AptaPharma Inc., 1533 Union Ave., Pennsauken, NJ 08110.
ANDA 215065	Methocarbamol solution, 1 g/10 mL (100 mg/mL)	Baxter Healthcare Corp.