Document ID: FDA-2022-N-0766-0001
Agency: fda
Document Type: Notice
Title: Hospira, Inc., et al.; Withdrawal of
Approval of 21 Abbreviated New Drug
Applications
Posted Date: 2022-05-20T04:00Z

[Federal Register Volume 87, Number 98 (Friday, May 20, 2022)]
[Notices]
[Pages 30962-30963]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-10924]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0766]

Hospira, Inc., et al.; Withdrawal of Approval of 21 Abbreviated 
New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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approval of the applications be withdrawn.

DATES: Approval is withdrawn as of June 21, 2022.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, [email protected].

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 Sec.  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 Sec.  314.150(c) is without prejudice to refiling.

------------------------------------------------------------------------
      Application No.                Drug                Applicant
------------------------------------------------------------------------
ANDA 040140...............  Diphenhydramine        Hospira, Inc., 275
                             Hydrochloride (HCl)    North Field Dr.,
                             Injection, 50          Building H1-3S, Lake
                             milligrams (mg)/       Forest, IL 60045.
                             milliliters (mL).
ANDA 040578...............  Benzphetamine HCl      ScinoPharm Taiwan,
                             Tablets, 50 mg.        Ltd., 909 N Ford
                                                    Ave., Fullerton, CA
                                                    92832.
ANDA 065267...............  Cefprozil Tablets,     Bionpharma Inc., 600
                             250 mg, and 500 mg.    Alexander Rd., Suite
                                                    2-4B, Princeton, NJ
                                                    08540.
ANDA 065284...............  Cefprozil Oral         Do.
                             Suspension, 125 mg/5
                             mL and 250 mg/5 mL.

[[Page 30963]]

 
ANDA 065301...............  Cefadroxil Tablets,    Do.
                             Equivalent to (EQ) 1
                             gram (g) base.
ANDA 065307...............  Cefadroxil Oral        Do.
                             Suspension, EQ 250
                             mg base/5 mL and EQ
                             500 mg base/5 mL.
ANDA 065309...............  Cefadroxil Capsules,   Do.
                             EQ 500 mg base.
ANDA 065326...............  Cephalexin Oral        Do.
                             Suspension, EQ 125
                             mg base/5 mL and EQ
                             250 mg base/5 mL.
ANDA 076720...............  Morphine Sulfate       Nesher
                             Extended Release       Pharmaceuticals
                             Tablets, 30 mg, and    (USA) LLC., 13910
                             60 mg.                 Saint Charles Rock
                                                    Rd., Bridgeton, MO
                                                    63044.
ANDA 076733...............  Morphine Sulfate       Do.
                             Extended Release
                             Tablets, 15 mg.
ANDA 077855...............  Morphine Sulfate       Do.
                             Extended Release
                             Tablets, 100 mg and
                             200 mg.
ANDA 080225...............  Potassium Chloride     Fresenius Kabi USA,
                             Injection, 2           LLC, Three Corporate
                             milliequivalent        Dr., Lake Zurich, IL
                             (mEq)/mL and 3 mEq/    60047.
                             mL.
ANDA 202393...............  Diclofenac Sodium      TWi Pharmaceuticals,
                             Topical Solution,      Inc., 536 Vanguard
                             1.5%.                  Way, Brea, CA 92821.
ANDA 203581...............  Glyburide Tablets,     Sunny Pharmtech Inc.,
                             1.25 mg, 2.5 mg, and   175 SW 166th Ave.,
                             5 mg.                  Pembroke Pines, FL
                                                    33027.
ANDA 204137...............  Omeprazole and Sodium  Unicorn
                             Bicarbonate            Pharmaceuticals, 5
                             Capsules, 20 mg; 1.1   Links Circle,
                             g.                     Durham, NC 27707.
ANDA 206588...............  Dextroamphetamine      Nesher
                             Sulfate Tablets, 5     Pharmaceuticals
                             mg, and 10 mg.         (USA) LLC.
ANDA 208263...............  Doxycycline Hyclate    Do.
                             Capsules, EQ 50 mg
                             base and EQ 100 mg
                             base.
ANDA 209111...............  Dextroamphetamine      Do.
                             Sulfate Extended
                             Release Capsules, 5
                             mg, 10 mg, and 15 mg.
ANDA 210079...............  Oxycodone and          Do.
                             Acetaminophen
                             Tablets, 325 mg; 2.5
                             mg, 325 mg; 5 mg,
                             325 mg; 7.5 mg, 325
                             mg; 10 mg.
ANDA 210080...............  Dextroamphetamine      Do.
                             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.
ANDA 211543...............  Butalbital,            Do.
                             Acetaminophen, and
                             Caffeine Tablets,
                             325 mg; 50 mg; 40 mg.
------------------------------------------------------------------------

    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