2024-21432. Allergan, Inc., et al.; Withdrawal of Approval of Nine Abbreviated New Drug Applications

Table 1—ANDAs for Which Approval Is Withdrawn

Application No.	Drug	Applicant
ANDA 062452	Gentamicin Sulfate solution/drop, Equivalent to (EQ) 0.3% base	Allergan, Inc., 2525 Dupont Dr., P.O. Box 19534, Irvine, CA 92612.
ANDA 064124	Cefuroxime Sodium injectable, EQ 7.5 grams (g) base/vial	ACS Dobfar S.p.A., U.S. Agent Interchem Corp., 120 Route 17 North, Paramus, NJ 07652.
ANDA 077151	Milrinone Lactate injectable, EQ 40 milligrams (mg) base/200 milliliters (mL) (EQ 0.2 mg base/mL) EQ 20 mg base/100 mL (EQ 0.2 mg base/mL)	Woodward Pharma Services, LLC, 47220 Cartier Dr., Suite A, Wixom, MI 48393.
ANDA 079032	Ondansetron Hydrochloride preservative free injectable, EQ 2 mg base/mL	American Regent, Inc., 5 Ramsey Rd., Shirley, NY 11967.
ANDA 079075	Fentanyl Citrate tablet, EQ 0.1 mg base, EQ 0.2 mg base, EQ 0.4 mg base, EQ 0.6 mg base, and EQ 0.8 mg base	Watson Laboratories, Inc., (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace Pkwy., Bldg. A, Parsippany, NJ 07054.
ANDA 206155	Olanzapine tablet, 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, and 20 mg	Indoco Remedies Ltd., U.S. Agent RegCon Solutions, LLC, 9920 Pacific Heights Blvd., Suite 250, San Diego, CA 92121.
ANDA 206204	Piperacillin Sodium and Tazobactam Sodium injectable, EQ 12 gm base/vial, EQ 1.5 gm base/vial	Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich, IL 60047.
ANDA 207919	Acyclovir Sodium injectable, EQ 50 mg base/mL	Dr. Reddy's Laboratories, Inc., 107 College Rd. East, Princeton, NJ 08540.
ANDA 209708	Mivacurium Chloride solution, EQ 10 mg base/5 mL (EQ 2 mg base/mL) and EQ 20 mg base/10 mL (EQ 2 mg base/mL)	Woodward Pharma Services, LLC.