Document ID: FDA-2018-N-0478-0001
Agency: fda
Document Type: Notice
Title: Sebela Ireland, Ltd. et al.; Withdrawal of Approval of 24 Abbreviated New
Drug Applications
Posted Date: 2018-02-23T05:00Z

[Federal Register Volume 83, Number 37 (Friday, February 23, 2018)]
[Notices]
[Pages 8089-8090]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-03700]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0478]

Sebela Ireland, Ltd. et al.; Withdrawal of Approval of 24 
Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is 
withdrawing approval of 24 abbreviated

[[Page 8090]]

new drug applications (ANDAs) from multiple applicants. The holders of 
the applications 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applications be withdrawn.

DATES: Approval is withdrawn as of March 26, 2018.

FOR FURTHER INFORMATION CONTACT: Trang Tran, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-402-7945, 
[email protected].

SUPPLEMENTARY INFORMATION: The holders of the applications 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 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 040398............  MiCort-HC                Sebela Ireland, Ltd.,
                          (hydrocortisone          c/o Sebela
                          acetate) Cream USP, 2%.  Pharmaceuticals,
                                                   Inc., 645 Hembree
                                                   Parkway, Suite 1,
                                                   Roswell, GA 30076.
ANDA 071893............  Acetohexamide Tablets,   Watson Laboratories,
                          250 milligrams (mg).     Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc., 425 Privet
                                                   Rd., Horsham, PA
                                                   19044.
ANDA 071894............  Acetohexamide Tablets,    Do.
                          500 mg.
ANDA 073143............  Cyclobenzaprine           Do.
                          Hydrochloride (HCl)
                          Tablets USP, 10 mg.
ANDA 074576............  Captopril Tablets USP,    Do.
                          12.5 mg, 25 mg, 50 mg,
                          and 100 mg.
ANDA 076607............  Quinapril Tablets USP,   Sun Pharmaceutical
                          Equivalent to (EQ) 5     Industries, Ltd., c/o
                          mg base, EQ 10 mg        Sun Pharmaceutical
                          base, EQ 20 mg base,     Industries, Inc., 2
                          and EQ 40 mg base.       Independence Way,
                                                   Princeton, NJ 08540.
ANDA 076786............  Donepezil HCl Tablets     Do.
                          USP, 5 mg and 10 mg.
ANDA 077483............  Benazepril HCl and        Do.
                          Hydrochlorothiazide
                          Tablets, 5 mg/6.25 mg,
                          10 mg/12.5 mg, 20 mg/
                          12.5 mg, and 20 mg/25
                          mg.
ANDA 078502............  Eliphos (calcium         Cypress
                          acetate) Tablets USP,    Pharmaceutical, Inc.,
                          667 mg.                  10 North Park Pl.,
                                                   Suite 201,
                                                   Morristown, NJ 07960.
ANDA 081019............  Chlorzoxazone Tablets    Watson Laboratories,
                          USP, 500 mg.             Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 083821............  Brompheniramine Maleate   Do.
                          Injection, 10 mg/
                          milliliter (mL).
ANDA 084408............  Bethanechol Chloride      Do.
                          Tablets USP, 10 mg.
ANDA 084441............  Bethanechol Chloride      Do.
                          Tablets USP, 25 mg.
ANDA 085283............  Theolair (theophylline)  3M Drug Delivery
                          Tablets, 125 mg and      Systems, 3M Center,
                          250 mg.                  Bldg. 275-3E-02, 2510
                                                   Conway Ave., St.
                                                   Paul, MN 55144.
ANDA 085738............  Betamethasone Sodium     Watson Laboratories,
                          Phosphate Injection,     Inc., Subsidiary of
                          EQ 3 mg base/mL.         Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 087444............  Bethanechol Chloride     Watson Laboratories,
                          Tablets USP, 50 mg.      Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 087792............  Fluorouracil Injection   Spectrum
                          USP, 50 mg/mL.           Pharmaceuticals,
                                                   Inc., 157 Technology
                                                   Dr., Irvine, CA
                                                   92618.
ANDA 087978............  Diphenhydramine HCl      LNK International,
                          Capsules, 50 mg.         Inc., 145 Ricefield
                                                   Ln., Hauppauge, NY
                                                   11788.
ANDA 090417............  Carbinoxamine Maleate    Cypress
                          Tablets USP, 4 mg.       Pharmaceutical, Inc.
ANDA 090418............  Carbinoxamine Maleate     Do.
                          Oral Solution, 4 mg/5
                          mL.
ANDA 090468............  Zyfrel (acetaminophen     Do.
                          and hydrocodone
                          bitartrate) Oral
                          Solution, 325 mg/7.5
                          mg per 15 mL.
ANDA 091034............  Dorzolamide HCl          Zambon S.p.A., c/o
                          Ophthalmic Solution      Camargo
                          USP, EQ 2% base.         Pharmaceutical
                                                   Services, LLC, 9825
                                                   Kenwood Rd., Suite
                                                   203, Cincinnati, OH
                                                   45242.
ANDA 200794............  Pantoprazole Sodium      Sun Pharmaceutical
                          Delayed-Release          Industries, Ltd., c/o
                          Tablets USP, EQ 20 mg    Sun Pharmaceutical
                          base and EQ 40 mg base.  Industries, Inc.
ANDA 206438............  Hydrocodone Bitartrate   Tris Pharma, Inc.,
                          and Chlorpheniramine     2033 Route 130, Suite
                          Maleate Oral Solution,   D, Monmouth Junction,
                          5 mg/4 mg per 5 mL.      NJ 08852.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of March 
26, 2018. 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 March 26, 2018 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: February 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03700 Filed 2-22-18; 8:45 am]
 BILLING CODE 4164-01-P