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 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2022-N-0766]
 AGENCY: Food and Drug Administration, HHS.
 ACTION: Notice.
 SUMMARY: The Food and Drug Administration (FDA or Agency) is withdrawing approval of 21 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
 DATES: Approval is withdrawn as of June 21, 2022.
 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, 240-402-6980, 
                        *Martha.Nguyen@fda.hhs.gov*.


SUPPLEMENTARY INFORMATION: The applicants listed in the table have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process described in § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) is without prejudice to refiling. Application No.
Drug
ApplicantANDA 040140
Diphenhydramine Hydrochloride (HCl) Injection, 50 milligrams (mg)/milliliters (mL)
Hospira, Inc., 275 North Field Dr., Building H1-3S, Lake Forest, IL 60045.ANDA 040578
Benzphetamine HCl Tablets, 50 mg
ScinoPharm Taiwan, Ltd., 909 N Ford Ave., Fullerton, CA 92832.ANDA 065267
Cefprozil Tablets, 250 mg, and 500 mg
Bionpharma Inc., 600 Alexander Rd., Suite 2-4B, Princeton, NJ 08540.ANDA 065284
Cefprozil Oral Suspension, 125 mg/5 mL and 250 mg/5 mL
Do.( print page 30963)ANDA 065301
Cefadroxil Tablets, Equivalent to (EQ) 1 gram (g) base
Do.ANDA 065307
Cefadroxil Oral Suspension, EQ 250 mg base/5 mL and EQ 500 mg base/5 mL
Do.ANDA 065309
Cefadroxil Capsules, EQ 500 mg base
Do.ANDA 065326
Cephalexin Oral Suspension, EQ 125 mg base/5 mL and EQ 250 mg base/5 mL
Do.ANDA 076720
Morphine Sulfate Extended Release Tablets, 30 mg, and 60 mg
Nesher Pharmaceuticals (USA) LLC., 13910 Saint Charles Rock Rd., Bridgeton, MO 63044.ANDA 076733
Morphine Sulfate Extended Release Tablets, 15 mg
Do.ANDA 077855
Morphine Sulfate Extended Release Tablets, 100 mg and 200 mg
Do.ANDA 080225
Potassium Chloride Injection, 2 milliequivalent (mEq)/mL and 3 mEq/mL
Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich, IL 60047.ANDA 202393
Diclofenac Sodium Topical Solution, 1.5%
TWi Pharmaceuticals, Inc., 536 Vanguard Way, Brea, CA 92821.ANDA 203581
Glyburide Tablets, 1.25 mg, 2.5 mg, and 5 mg
Sunny Pharmtech Inc., 175 SW 166th Ave., Pembroke Pines, FL 33027.ANDA 204137
Omeprazole and Sodium Bicarbonate Capsules, 20 mg; 1.1 g
Unicorn Pharmaceuticals, 5 Links Circle, Durham, NC 27707.ANDA 206588
Dextroamphetamine Sulfate Tablets, 5 mg, and 10 mg
Nesher Pharmaceuticals (USA) LLC.ANDA 208263
Doxycycline Hyclate Capsules, EQ 50 mg base and EQ 100 mg base
Do.ANDA 209111
Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 10 mg, and 15 mg
Do.ANDA 210079
Oxycodone and Acetaminophen Tablets, 325 mg; 2.5 mg, 325 mg; 5 mg, 325 mg; 7.5 mg, 325 mg; 10 mg
Do.ANDA 210080
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended Release Capsules, 1.25 mg; 1.25 mg; 1.25 mg; 1.25 mg, 2.5 mg; 2.5 mg; 2.5 mg; 2.5 mg, 3.75 mg; 3.75 mg; 3.75 mg; 3.75 mg, 5 mg; 5 mg; 5 mg; 5 mg, 6.25 mg; 6.25 mg; 6.25 mg; 6.25 mg, 7.5 mg; 7.5 mg; 7.5 mg; 7.5 mg
Do.ANDA 211543
Butalbital, Acetaminophen, and Caffeine Tablets, 325 mg; 50 mg; 40 mg
Do.
 Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of June 21, 2022. Approval of each entire application is withdrawn, including any strengths and dosage forms inadvertently missing from the table. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in the table that are in inventory on June 21, 2022, may continue to be dispensed until the inventories have been depleted or the drug products have reached their expiration dates or otherwise become violative, whichever occurs first. Dated: May 13, 2022. Lauren K. Roth, Associate Commissioner for Policy.


[FR Doc. 2022-10924 Filed 5-19-22; 8:45 am] BILLING CODE 4164-01-P