[Federal Register Volume 86, Number 10 (Friday, January 15, 2021)]
[Notices]
[Pages 4081-4083]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-00833]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-2306]


TG United Inc., et al.; Withdrawal of Approval of 27 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 27 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approval of the applications be withdrawn.

DATES: Approval is withdrawn as of February 16, 2021.

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 040083...................  Phentermine             TG United Inc.,
                                 Hydrochloride (HCl)     16275 Aviation
                                 Capsules, 30            Loop Dr.,
                                 milligrams (mg).        Brooksville, FL
                                                         34604.
ANDA 040451...................  Cyanocobalamin          Mylan
                                 Injection, 1 mg/        Institutional
                                 milliliters (mL).       LLC, 4901
                                                         Hiawatha Dr.,
                                                         Rockford, IL
                                                         61103.
ANDA 040518...................  Bethanechol Chloride    Morton Grove
                                 Tablets, 50 mg.         Pharmaceuticals
                                                         Inc./Wockhardt
                                                         USA LLC, 6451
                                                         W. Main St.,
                                                         Morton Grove,
                                                         IL 60053.
ANDA 040532...................  Bethanechol Chloride    Do.
                                 Tablets, 5 mg.

[[Page 4082]]

 
ANDA 060347...................  Tetracycline HCl        Pharmacia &
                                 Capsules, 250 mg.       Upjohn Co., a
                                                         subsidiary of
                                                         Pfizer Inc.,
                                                         235 East 42nd
                                                         St., New York,
                                                         NY 10017.
ANDA 060478...................  Neomycin Sulfate        Pfizer Inc., 235
                                 Ophthalmic Ointment.    East 42nd St.,
                                                         New York, NY
                                                         10017.
ANDA 065266...................  Clarithromycin          Morton Grove
                                 Tablets, 250 mg and     Pharmaceuticals
                                 500 mg.                 Inc./Wockhardt
                                                         USA LLC.
ANDA 065281...................  Doxycycline Hyclate     Bausch Health
                                 Delayed Release         US, LLC, 400
                                 Capsules, Equivalent    Somerset
                                 to (EQ) 75 mg base;     Corporate
                                 EQ 100 mg base.         Blvd.,
                                                         Bridgewater, NJ
                                                         08807.
ANDA 075208...................  Ranitidine HCl          Morton Grove
                                 Tablets, EQ 150 mg      Pharmaceuticals
                                 base; EQ 300 mg base.   Inc./Wockhardt
                                                         USA LLC.
ANDA 075822...................  Loratadine Orally       GlaxoSmithKline
                                 Disintegrating          Consumer
                                 Tablets, 10 mg.         Healthcare
                                                         Holdings (US)
                                                         LLC, 184
                                                         Liberty Corner
                                                         Rd., Suite 200,
                                                         Warren, NJ
                                                         07059.
ANDA 076760...................  Ranitidine HCl          Morton Grove
                                 Tablets, EQ 75 mg       Pharmaceuticals
                                 base.                   Inc./Wockhardt
                                                         USA LLC.
ANDA 076849...................  Vinorelbine Tartrate    Fresenius Kabi
                                 Injection, EQ 10 mg     USA, LLC, Three
                                 base/mL.                Corporate Dr.,
                                                         Lake Zurich, IL
                                                         60047.
ANDA 077432...................  Carboplatin Injection,  Do.
                                 50 mg/5 mL(10 mg/mL),
                                 150 mg/15 mL (10 mg/
                                 mL), and 450 mg/45 mL
                                 (10 mg/mL).
ANDA 078500...................  Amlodipine Besylate     Morton Grove
                                 Tablets, EQ 2.5 mg      Pharmaceuticals
                                 base; EQ 5 mg base;     Inc./Wockhardt
                                 EQ 10 mg base.          USA LLC.
ANDA 084041...................  Chlordiazepoxide HCl    Upsher-Smith
                                 Capsules, 10 mg.        Laboratories,
                                                         LLC, 6701
                                                         Evenstad Dr.,
                                                         Maple Grove, MN
                                                         55369.
ANDA 084678...................  Chlordiazepoxide HCl    Do.
                                 Capsules, 5 mg.
ANDA 084679...................  Chlordiazepoxide HCl    Do.
                                 Capsules, 25 mg.
ANDA 088508...................  Homatropine             King
                                 Methylbromide;          Pharmaceuticals
                                 Hydrocodone             Research and
                                 Bitartrate Tablets,     Development,
                                 1.5 mg; 5 mg.           LLC, 4000
                                                         Centregreen
                                                         Way, Suite 300,
                                                         Cary, NC 27513.
ANDA 089953...................  Thioridazine HCl        Sun
                                 Tablets, 10 mg, 25      Pharmaceutical
                                 mg, 50 mg, and 100 mg.  Industries,
                                                         Inc., 2
                                                         Independence
                                                         Way, Princeton,
                                                         NJ 08540.
ANDA 090094...................  Didanosine Delayed      Aurobindo Pharma
                                 Release Capsules, 125   USA, Inc., 279
                                 mg, 200 mg, 250 mg,     Princeton-
                                 and 400 mg.             Hightstown Rd.,
                                                         East Windsor,
                                                         NJ 08520.
ANDA 090394...................  Iopamidol Injection,    Sanochemia
                                 61% and 76%.            Corporation
                                                         USA, 9201
                                                         University City
                                                         Blvd., c/o
                                                         Countervail
                                                         Corp.,
                                                         Charlotte, NC
                                                         08876.
ANDA 091302...................  Fludrocortisone         Hikma
                                 Acetate Tablets, 0.1    Pharmaceuticals
                                 mg.                     USA Inc., 1809
                                                         Wilson Rd.,
                                                         Columbus, OH
                                                         43228.
ANDA 203959...................  Temozolomide Capsules,  Watson
                                 5 mg, 20 mg, 100 mg,    Laboratories,
                                 140 mg, and 250 mg.     Inc. (an
                                                         indirect,
                                                         wholly owned
                                                         subsidiary of
                                                         Teva
                                                         Pharmaceuticals
                                                         USA, Inc.), 425
                                                         Privet Rd.,
                                                         Horsham, PA
                                                         19044.
ANDA 204243...................  Indomethacin Extended   Aurobindo Pharma
                                 Release Capsules, 75    USA, Inc.
                                 mg.
ANDA 206061...................  Pravastatin Sodium      Hisun
                                 Tablets, 20 mg, 40      Pharmaceuticals
                                 mg, and 80 mg.          USA, Inc., 200
                                                         Crossing Blvd.,
                                                         2nd Floor,
                                                         Bridgewater, NJ
                                                         08807.
ANDA 206857...................  Tiagabine HCl Tablets,  Wilshire
                                 2 mg, 4 mg, 12 mg,      Pharmaceuticals
                                 and 16 mg.              , Inc., 6
                                                         Concourse
                                                         Pkwy., Suite
                                                         1800, Atlanta,
                                                         GA 30328.
ANDA 209076...................  Ibuprofen Tablets, 200  Ultra Tab
                                 mg.                     Laboratories,
                                                         Inc., 50 Toc
                                                         Dr., Highland,
                                                         NY 12528.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of 
February 16, 2021. 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 February 16, 2021 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.


[[Page 4083]]


    Dated: January 11, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-00833 Filed 1-14-21; 8:45 am]
BILLING CODE 4164-01-P