[Federal Register Volume 83, Number 1 (Tuesday, January 2, 2018)]
[Notices]
[Pages 128-131]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-28254]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-6852]


Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals 
USA, Inc. et al.; Withdrawal of Approval of 111 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 111 abbreviated 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requested that the approval of the applications be withdrawn.

DATES: Approval is withdrawn as of February 1, 2018.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,

[[Page 129]]

MD 20993-0002, 240-402-7945, [email protected].

SUPPLEMENTARY INFORMATION: The holders of the applications listed in 
table 1 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.

                                 Table 1
------------------------------------------------------------------------
   Application No.              Drug                    Applicant
------------------------------------------------------------------------
ANDA 040008.........  Heparin Sodium Injection  Watson Laboratories,
                       USP, 1000 units/          Inc., Subsidiary of
                       milliliter (mL).          Teva Pharmaceuticals
                                                 USA, Inc., 425 Privet
                                                 Rd., Horsham, PA 19044.
ANDA 040137.........  Chlorzoxazone Tablets     Do.
                       USP, 500 milligrams
                       (mg).
ANDA 040410.........  Methylphenidate           Do.
                       Hydrochloride (HCl)
                       Extended-Release
                       Tablets USP, 20 mg.
ANDA 040456.........  Amphetamine Aspartate;    Actavis Elizabeth, LLC,
                       Amphetamine Sulfate;      Subsidiary of Teva
                       Dextroamphetamine         Pharmaceuticals USA,
                       Saccharate;               Inc., 425 Privet Rd.,
                       Dextroamphetamine         Horsham, PA 19044.
                       Sulfate Tablets, 1.25
                       mg/1.25 mg/1.25 mg/1.25
                       mg, 2.5 mg/2.5 mg/2.5
                       mg/2.5 mg, 5 mg/5 mg/5
                       mg/5 mg, and 7.5 mg/7.5
                       mg/7.5 mg/7.5 mg.
ANDA 040666.........  A-Hydrocort               Hospira, Inc., a Pfizer
                       (hydrocortisone sodium    Company, 275 North
                       succinate) for            Field Dr., Bldg. H1,
                       Injection USP,            Lake Forest, IL 60045.
                       Equivalent to (EQ) 100
                       mg base/vial.
ANDA 062520.........  Kanamycin Sulfate         Watson Laboratories,
                       Injection, EQ 1 gram      Inc., Subsidiary of
                       (g) base/3 mL.            Teva Pharmaceuticals
                                                 USA, Inc.
ANDA 062693.........  Cephradine for Oral       Teva Pharmaceuticals
                       Suspension USP, 125 mg/   USA, Inc., 425 Privet
                       5 mL and 250 mg/5 mL.     Rd., Horsham, PA 19044.
ANDA 062844.........  Nafcillin for Injection   Watson Laboratories,
                       USP, EQ 500 mg base/      Inc., Subsidiary of
                       vial, EQ 1 g base/vial,   Teva Pharmaceuticals
                       EQ 1.5 g base/vial, EQ    USA, Inc.
                       2 g base/vial, and EQ 4
                       g base/vial.
ANDA 062856.........  Oxacillin for Injection   Do.
                       USP, EQ 250 mg base/
                       vial, EQ 500 mg base/
                       vial, EQ 1 g base/vial,
                       EQ 2 g base/vial, and
                       EQ 4 g base/vial.
ANDA 062984.........  Oxacillin for Injection   Do.
                       USP, EQ 10 g base/vial
                       (Pharmacy Bulk Package).
ANDA 062991.........  Penicillin G Potassium    Do.
                       for Injection USP, 1
                       million units/vial, 5
                       million units/vial, 10
                       million units/vial, and
                       20 million units/vial.
ANDA 063008.........  Nafcillin for Injection   Do.
                       USP, EQ 10 g base/vial
                       (Pharmacy Bulk Package).
ANDA 063014.........  Penicillin G Sodium for   Do.
                       Injection USP, 5
                       million units/vial.
ANDA 063106.........  Gentamicin Injection      Teva Pharmaceuticals
                       USP, EQ 40 mg base/mL.    USA, Inc.
ANDA 064035.........  Cefuroxime for Injection  Watson Laboratories,
                       USP, EQ 750 mg base/      Inc., Subsidiary of
                       vial and EQ 1.5 g base/   Teva Pharmaceuticals
                       vial.                     USA, Inc.
ANDA 065280.........  Cefazolin for Injection   Cephazone Pharma, LLC,
                       USP, EQ 500 mg base/      250 E. Bonita Ave.,
                       vial and EQ 1 g base/     Pomona, CA 91767.
                       vial.
ANDA 065294.........  Ceftriaxone for           Do.
                       Injection USP, EQ 250
                       mg base/vial, EQ 500 mg
                       base/vial, EQ 1 g base/
                       vial, and EQ 2 g base/
                       vial.
ANDA 065295.........  Cefazolin for Injection   Do.
                       USP, EQ 10 g base/vial
                       (Pharmacy Bulk Package).
ANDA 065296.........  Cefazolin for Injection   Do.
                       USP, EQ 20 g base/vial
                       (Pharmacy Bulk Package).
ANDA 070301.........  Propranolol HCl and       Watson Laboratories,
                       Hydrochlorothiazide       Inc., Subsidiary of
                       Tablets USP, 40 mg/25     Teva Pharmaceuticals
                       mg.                       USA, Inc.
ANDA 070305.........  Propranolol HCl and       Do.
                       Hydrochlorothiazide
                       Tablets USP, 80 mg/25
                       mg.
ANDA 070468.........  Verapamil HCl Tablets     Actavis Elizabeth, LLC,
                       USP, 120 mg.              Subsidiary of Teva
                                                 Pharmaceuticals USA,
                                                 Inc.
ANDA 070549.........  Propranolol HCl Tablets   Watson Laboratories,
                       USP, 20 mg.               Inc., Subsidiary of
                                                 Teva Pharmaceuticals
                                                 USA, Inc.
ANDA 070703.........  Methyldopa Tablets USP,   Do.
                       250 mg.
ANDA 070714.........  Haloperidol Injection     Do.
                       USP, EQ 5 mg base/mL.
ANDA 070851.........  Propranolol HCl and       Actavis Elizabeth, LLC,
                       Hydrochlorothiazide       Subsidiary of Teva
                       Tablets USP, 40 mg/25     Pharmaceuticals USA,
                       mg.                       Inc.
ANDA 070852.........  Propranolol HCl and       Do.
                       Hydrochlorothiazide
                       Tablets USP, 80 mg/25
                       mg.
ANDA 070855.........  Verapamil HCl Tablets     Watson Laboratories,
                       USP, 80 mg.               Inc., Subsidiary of
                                                 Teva Pharmaceuticals
                                                 USA, Inc.
ANDA 070958.........  Methyldopa and            Do.
                       Hydrochlorothiazide
                       Tablets USP, 250 mg/15
                       mg.
ANDA 070959.........  Methyldopa and            Do.
                       Hydrochlorothiazide
                       Tablets USP, 250 mg/25
                       mg.
ANDA 070960.........  Methyldopa and            Do.
                       Hydrochlorothiazide
                       Tablets USP, 500 mg/50
                       mg.

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ANDA 071069.........  Methyldopa and            Do.
                       Hydrochlorothiazide
                       Tablets USP, 500 mg/30
                       mg.
ANDA 071110.........  Lorazepam Tablets USP, 2  Do.
                       mg.
ANDA 071117.........  Lorazepam Tablets USP,    Do.
                       0.5 mg.
ANDA 071118.........  Lorazepam Tablets USP, 1  Do.
                       mg.
ANDA 071485.........  Doxepin HCl Capsules      Do.
                       USP, EQ 10 mg base.
ANDA 071486.........  Doxepin HCl Capsules      Do.
                       USP, EQ 25 mg base.
ANDA 071666.........  Ibuprofen Tablets, 400    Pliva, Inc., Subsidiary
                       mg.                       of Teva Pharmaceuticals
                                                 USA, Inc., 425 Privet
                                                 Rd., Horsham, PA 19044.
ANDA 071792.........  Propranolol HCl Tablets   Watson Laboratories,
                       USP, 90 mg.               Inc., Subsidiary of
                                                 Teva Pharmaceuticals
                                                 USA, Inc.
ANDA 071883.........  Betamethasone Valerate    Teva Pharmaceuticals
                       Lotion USP, EQ 0.1%       USA, Inc.
                       base.
ANDA 071919.........  Nalidixic Acid Tablets    Watson Laboratories,
                       USP, 1 g.                 Inc., Subsidiary of
                                                 Teva Pharmaceuticals
                                                 USA, Inc.
ANDA 071936.........  Nalidixic Acid Tablets    Do.
                       USP, 250 mg.
ANDA 072061.........  Nalidixic Acid Tablets    Do.
                       USP, 500 mg.
ANDA 072164.........  Maprotiline HCl Tablets   Do.
                       USP, 75 mg.
ANDA 072795.........  Metaproterenol Sulfate    Do.
                       Tablets USP, 20 mg.
ANDA 072824.........  Baclofen Tablets USP, 10  Do.
                       mg.
ANDA 073373.........  Morphine Sulfate          Do.
                       Injection USP, 1 mg/2
                       mL (Ampule).
ANDA 073374.........  Morphine Sulfate          Do.
                       Injection USP, 10 mg/10
                       mL (Ampule).
ANDA 073375.........  Morphine Sulfate          Do.
                       Injection USP, 5 mg/10
                       mL (Vial).
ANDA 073376.........  Morphine Sulfate          Do.
                       Injection USP, 10 mg/10
                       mL (Vial).
ANDA 073443.........  Meperidine HCl Injection  Do.
                       USP, 10 mg/mL
                       (Preservative Free).
ANDA 073444.........  Meperidine HCl Injection  Do.
                       USP, 50 mg/mL.
ANDA 073529.........  Doxapram HCl Injection    Do.
                       USP, 20 mg/mL.
ANDA 074032.........  Metoprolol Tartrate       Do.
                       Injection USP, 1 mg/mL.
ANDA 074195.........  Naproxen Sodium Tablets   Do.
                       USP, EQ 250 mg base and
                       EQ 500 mg base.
ANDA 074276.........  Lorazepam Injection USP,  Do.
                       2 mg/mL and 4 mg/mL.
ANDA 074279.........  Dobutamine..............  Do.
                      Injection USP, EQ 12.5
                       mg base/mL.
ANDA 074393.........  Isoflurane USP, 99.9%...  Do.
ANDA 074457.........  Naproxen Tablets USP,     Do.
                       250 mg, 375 mg, and 500
                       mg.
ANDA 074598.........  Hydromorphone HCl         Hospira, Inc.
                       Injection USP, 10 mg/mL.
ANDA 074864.........  Ranitidine Tablets USP,   Watson Laboratories,
                       EQ 150 mg base and EQ     Inc., Subsidiary of
                       300 mg base.              Teva Pharmaceuticals
                                                 USA, Inc.
ANDA 074906.........  Acyclovir Capsules USP,   Actavis Elizabeth, LLC,
                       200 mg.                   Subsidiary of Teva
                                                 Pharmaceuticals USA,
                                                 Inc.
ANDA 075253.........  Ticlopidine HCl Tablets,  Do.
                       250 mg.
ANDA 075650.........  Famotidine Tablets USP,   Do.
                       20 mg and 40 mg.
ANDA 075672.........  Bisoprolol Fumarate and   Do.
                       Hydrochlorothiazide
                       Tablets, 2.5 mg/6.25
                       mg, 5 mg/6.25 mg, and
                       10 mg/6.25 mg.
ANDA 075843.........  Oxaprozin Tablets, 600    Do.
                       mg.
ANDA 075901.........  Fluvoxamine Maleate       Do.
                       Tablets, 25 mg, 50 mg,
                       and 100 mg.
ANDA 075960.........  Tramadol HCl Tablets, 50  Do.
                       mg.
ANDA 076689.........  Mirtazapine Orally        Do.
                       Disintegrating Tablets
                       USP, 15 mg, 30 mg, and
                       45 mg.
ANDA 077174.........  Foscarnet Sodium          Hospira, Inc.
                       Injection, 2.4 g/100 mL.
ANDA 077963.........  Granisetron HCl           Teva Pharmaceuticals
                       Injection, EQ 1 mg base/  USA, Inc.
                       mL.
ANDA 080615.........  Dimenhydrinate            Watson Laboratories,
                       Injection, 50 mg/mL.      Inc., Subsidiary of
                                                 Teva Pharmaceuticals
                                                 USA, Inc.
ANDA 080713.........  Tripelennamine HCl        Do.
                       Tablets USP, 50 mg.
ANDA 081150.........  Hydroxyzine HCl Tablets   Do.
                       USP, 25 mg.
ANDA 081151.........  Hydroxyzine HCl Tablets   Do.
                       USP, 50 mg.
ANDA 083287.........  Procainamide HCl          Do.
                       Capsules USP, 250 mg.
ANDA 084280.........  Procainamide HCl          Do.
                       Capsules USP, 500 mg.
ANDA 084403.........  Procainamide HCl          Do.
                       Capsules USP, 375 mg.
ANDA 084467.........  Reserpine and             Do.
                       Hydrochlorothiazide
                       Tablets USP, 0.125 mg/
                       50 mg.
ANDA 085083.........  Diphenhydramine HCl       Do.
                       Capsules USP, 50 mg.
ANDA 085140.........  Quinidine Sulfate         Do.
                       Tablets USP, 200 mg.
ANDA 085173.........  Chlorothiazide Tablets    Do.
                       USP, 250 mg.
ANDA 085180.........  Methocarbamol Tablets     Do.
                       USP, 500 mg.
ANDA 085192.........  Methocarbamol Tablets     Do.
                       USP, 750 mg.
ANDA 085597.........  Methylprednisolone        Do.
                       Acetate Injectable
                       Suspension USP, 20 mg/
                       mL.
ANDA 086013.........  Statobex                  Teva Pharmaceuticals
                       (phendimetrazine          USA, Inc.
                       tartrate) Tablets USP,
                       35 mg.
ANDA 086029.........  Testosterone Cypionate    Watson Laboratories,
                       Injection USP, 100 mg/    Inc., Subsidiary of
                       mL.                       Teva Pharmaceuticals
                                                 USA, Inc.
ANDA 086031.........  Isosorbide Dinitrate      Do.
                       Sublingual Tablets USP,
                       5 mg.

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ANDA 086034.........  Isosorbide Dinitrate      Do.
                       Tablets USP, 5 mg.
ANDA 086188.........  Gerimal (ergoloid         Do.
                       mesylates) Sublingual
                       Tablets, 1 mg.
ANDA 086385.........  Nandrolone Decanoate      Do.
                       Injection, 50 mg/mL.
ANDA 086562.........  Wigraine (ergotamine      Organon USA, Inc.,
                       tartrate and caffeine)    Subsidiary of Merck &
                       Tablets USP, 1 mg/100     Co., Inc., 2000
                       mg.                       Galloping Hill Rd.,
                                                 Kenilworth, NJ 07033.
ANDA 086742.........  Choledyl SA               Warner Chilcott Co.,
                       (oxtriphylline)           LLC, Subsidiary of Teva
                       Extended-Release          Pharmaceuticals USA,
                       Tablets, 600 mg.          Inc., 425 Privet Rd.,
                                                 Horsham, PA 19044.
ANDA 086863.........  Chlorpromazine HCl Oral   Actavis Mid Atlantic,
                       Concentrate USP, 100 mg/  LLC, Subsidiary of Teva
                       mL.                       Pharmaceuticals USA,
                                                 Inc., 425 Privet Rd.,
                                                 Horsham, PA 19044.
ANDA 087233.........  Ergoloid Mesylates        Watson Laboratories,
                       Sublingual Tablets USP,   Inc., Subsidiary of
                       0.5 mg.                   Teva Pharmaceuticals
                                                 USA, Inc.
ANDA 087244.........  Ergoloid Mesylates        Do.
                       Tablets USP, 1 mg.
ANDA 087318.........  Tolbutamide Tablets USP,  Do.
                       500 mg.
ANDA 087727.........  Aminophylline Oral        Actavis Mid Atlantic,
                       Solution USP, 105 mg/5    LLC, Subsidiary of Teva
                       mL (Dye Free).            Pharmaceuticals USA,
                                                 Inc.
ANDA 088128.........  Nandrolone Decanoate      Watson Laboratories,
                       Injection, 200 mg/mL.     Inc., Subsidiary of
                                                 Teva Pharmaceuticals
                                                 USA, Inc.
ANDA 088337.........  Ergostat (ergotamine      Do.
                       tartrate) Sublingual
                       Tablets USP, 2 mg.
ANDA 088477.........  Thioridazine HCl Tablets  Do.
                       USP, 15 mg.
ANDA 088561.........  Thioridazine HCl Tablets  Do.
                       USP, 10 mg.
ANDA 088564.........  Thioridazine HCl Tablets  Do.
                       USP, 100 mg.
ANDA 088724.........  Methyclothiazide Tablets  Do.
                       USP, 5 mg.
ANDA 088734.........  Meclizine HCl Tablets,    Pliva, Inc., Subsidiary
                       25 mg.                    of Teva Pharmaceuticals
                                                 USA, Inc.
ANDA 088769.........  Mepivacaine HCl           Watson Laboratories,
                       Injection USP, 1%.        Inc., Subsidiary of
                                                 Teva Pharmaceuticals
                                                 USA, Inc.
ANDA 088770.........  Mepivacaine HCl           Do.
                       Injection USP, 2%.
ANDA 088872.........  Thioridazine HCl Tablets  Do.
                       USP, 200 mg.
ANDA 089026.........  Procainamide HCl          Do.
                       Extended-Release
                       Tablets USP, 250 mg.
ANDA 089027.........  Procainamide HCl          Do.
                       Extended-Release
                       Tablets USP, 500 mg.
ANDA 089530.........  Prochlorperazine          Do.
                       Edisylate Injection
                       USP, EQ 5 mg base/mL.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in table 1, and all 
amendments and supplements thereto, is hereby withdrawn as of February 
1, 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 table 1 that 
are in inventory on the date that this notice becomes effective (see 
DATES) 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: December 26, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-28254 Filed 12-29-17; 8:45 am]
 BILLING CODE 4164-01-P