Document headings vary by document type but may contain
                    the following: the agency or agencies that issued and signed a document
the number of the CFR title and the number of each part
                      the document amends, proposes to amend, or is directly
                      related to
the agency docket number / agency internal file number
the RIN which identifies each regulatory action listed in
                      the Unified Agenda of Federal Regulatory and Deregulatory
                      Actions See the
                    Document Drafting Handbook
                    for more details.
 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2017-N-6852]
 AGENCY: Food and Drug Administration, HHS.
 ACTION: Notice.
 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
 DATES: Approval is withdrawn as of February 1, 2018.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, 
                        ( print page 129)
                        MD 20993-0002, 240-402-7945, 
                        *Trang.Tran@fda.hhs.gov.*


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 § 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. Table 1
Application No.
Drug
ApplicantANDA 040008
Heparin Sodium Injection USP, 1000 units/milliliter (mL)
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.ANDA 040137
Chlorzoxazone Tablets USP, 500 milligrams (mg)
Do.ANDA 040410
Methylphenidate Hydrochloride (HCl) Extended-Release Tablets USP, 20 mg
Do.ANDA 040456
Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine 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
Actavis Elizabeth, LLC, Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.ANDA 040666
A-Hydrocort (hydrocortisone sodium succinate) for Injection USP, Equivalent to (EQ) 100 mg base/vial
Hospira, Inc., a Pfizer Company, 275 North Field Dr., Bldg. H1, Lake Forest, IL 60045.ANDA 062520
Kanamycin Sulfate Injection, EQ 1 gram (g) base/3 mL
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.ANDA 062693
Cephradine for Oral Suspension USP, 125 mg/5 mL and 250 mg/5 mL
Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.ANDA 062844
Nafcillin for Injection USP, EQ 500 mg base/vial, EQ 1 g base/vial, EQ 1.5 g base/vial, EQ 2 g base/vial, and EQ 4 g base/vial
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.ANDA 062856
Oxacillin for Injection 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
Do.ANDA 062984
Oxacillin for Injection USP, EQ 10 g base/vial (Pharmacy Bulk Package)
Do.ANDA 062991
Penicillin G Potassium for Injection USP, 1 million units/vial, 5 million units/vial, 10 million units/vial, and 20 million units/vial
Do.ANDA 063008
Nafcillin for Injection USP, EQ 10 g base/vial (Pharmacy Bulk Package)
Do.ANDA 063014
Penicillin G Sodium for Injection USP, 5 million units/vial
Do.ANDA 063106
Gentamicin Injection USP, EQ 40 mg base/mL
Teva Pharmaceuticals USA, Inc.ANDA 064035
Cefuroxime for Injection USP, EQ 750 mg base/vial and EQ 1.5 g base/vial
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.ANDA 065280
Cefazolin for Injection USP, EQ 500 mg base/vial and EQ 1 g base/vial
Cephazone Pharma, LLC, 250 E. Bonita Ave., Pomona, CA 91767.ANDA 065294
Ceftriaxone for Injection USP, EQ 250 mg base/vial, EQ 500 mg base/vial, EQ 1 g base/vial, and EQ 2 g base/vial
Do.ANDA 065295
Cefazolin for Injection USP, EQ 10 g base/vial (Pharmacy Bulk Package)
Do.ANDA 065296
Cefazolin for Injection USP, EQ 20 g base/vial (Pharmacy Bulk Package)
Do.ANDA 070301
Propranolol HCl and Hydrochlorothiazide Tablets USP, 40 mg/25 mg
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.ANDA 070305
Propranolol HCl and Hydrochlorothiazide Tablets USP, 80 mg/25 mg
Do.ANDA 070468
Verapamil HCl Tablets USP, 120 mg
Actavis Elizabeth, LLC, Subsidiary of Teva Pharmaceuticals USA, Inc.ANDA 070549
Propranolol HCl Tablets USP, 20 mg
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.ANDA 070703
Methyldopa Tablets USP, 250 mg
Do.ANDA 070714
Haloperidol Injection USP, EQ 5 mg base/mL
Do.ANDA 070851
Propranolol HCl and Hydrochlorothiazide Tablets USP, 40 mg/25 mg
Actavis Elizabeth, LLC, Subsidiary of Teva Pharmaceuticals USA, Inc.ANDA 070852
Propranolol HCl and Hydrochlorothiazide Tablets USP, 80 mg/25 mg
Do.ANDA 070855
Verapamil HCl Tablets USP, 80 mg
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.ANDA 070958
Methyldopa and Hydrochlorothiazide Tablets USP, 250 mg/15 mg
Do.ANDA 070959
Methyldopa and Hydrochlorothiazide Tablets USP, 250 mg/25 mg
Do.ANDA 070960
Methyldopa and Hydrochlorothiazide Tablets USP, 500 mg/50 mg
Do.( print page 130)ANDA 071069
Methyldopa and Hydrochlorothiazide Tablets USP, 500 mg/30 mg
Do.ANDA 071110
Lorazepam Tablets USP, 2 mg
Do.ANDA 071117
Lorazepam Tablets USP, 0.5 mg
Do.ANDA 071118
Lorazepam Tablets USP, 1 mg
Do.ANDA 071485
Doxepin HCl Capsules USP, EQ 10 mg base
Do.ANDA 071486
Doxepin HCl Capsules USP, EQ 25 mg base
Do.ANDA 071666
Ibuprofen Tablets, 400 mg
Pliva, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.ANDA 071792
Propranolol HCl Tablets USP, 90 mg
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.ANDA 071883
Betamethasone Valerate Lotion USP, EQ 0.1% base
Teva Pharmaceuticals USA, Inc.ANDA 071919
Nalidixic Acid Tablets USP, 1 g
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.ANDA 071936
Nalidixic Acid Tablets USP, 250 mg
Do.ANDA 072061
Nalidixic Acid Tablets USP, 500 mg
Do.ANDA 072164
Maprotiline HCl Tablets USP, 75 mg
Do.ANDA 072795
Metaproterenol Sulfate Tablets USP, 20 mg
Do.ANDA 072824
Baclofen Tablets USP, 10 mg
Do.ANDA 073373
Morphine Sulfate Injection USP, 1 mg/2 mL (Ampule)
Do.ANDA 073374
Morphine Sulfate Injection USP, 10 mg/10 mL (Ampule)
Do.ANDA 073375
Morphine Sulfate Injection USP, 5 mg/10 mL (Vial)
Do.ANDA 073376
Morphine Sulfate Injection USP, 10 mg/10 mL (Vial)
Do.ANDA 073443
Meperidine HCl Injection USP, 10 mg/mL (Preservative Free)
Do.ANDA 073444
Meperidine HCl Injection USP, 50 mg/mL
Do.ANDA 073529
Doxapram HCl Injection USP, 20 mg/mL
Do.ANDA 074032
Metoprolol Tartrate Injection USP, 1 mg/mL
Do.ANDA 074195
Naproxen Sodium Tablets USP, EQ 250 mg base and EQ 500 mg base
Do.ANDA 074276
Lorazepam Injection USP, 2 mg/mL and 4 mg/mL
Do.ANDA 074279
Dobutamine
                             Injection USP, EQ 12.5 mg base/mL
Do.ANDA 074393
Isoflurane USP, 99.9%
Do.ANDA 074457
Naproxen Tablets USP, 250 mg, 375 mg, and 500 mg
Do.ANDA 074598
Hydromorphone HCl Injection USP, 10 mg/mL
Hospira, Inc.ANDA 074864
Ranitidine Tablets USP, EQ 150 mg base and EQ 300 mg base
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.ANDA 074906
Acyclovir Capsules USP, 200 mg
Actavis Elizabeth, LLC, Subsidiary of Teva Pharmaceuticals USA, Inc.ANDA 075253
Ticlopidine HCl Tablets, 250 mg
Do.ANDA 075650
Famotidine Tablets USP, 20 mg and 40 mg
Do.ANDA 075672
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, 2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg/6.25 mg
Do.ANDA 075843
Oxaprozin Tablets, 600 mg
Do.ANDA 075901
Fluvoxamine Maleate Tablets, 25 mg, 50 mg, and 100 mg
Do.ANDA 075960
Tramadol HCl Tablets, 50 mg
Do.ANDA 076689
Mirtazapine Orally Disintegrating Tablets USP, 15 mg, 30 mg, and 45 mg
Do.ANDA 077174
Foscarnet Sodium Injection, 2.4 g/100 mL
Hospira, Inc.ANDA 077963
Granisetron HCl Injection, EQ 1 mg base/mL
Teva Pharmaceuticals USA, Inc.ANDA 080615
Dimenhydrinate Injection, 50 mg/mL
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.ANDA 080713
Tripelennamine HCl Tablets USP, 50 mg
Do.ANDA 081150
Hydroxyzine HCl Tablets USP, 25 mg
Do.ANDA 081151
Hydroxyzine HCl Tablets USP, 50 mg
Do.ANDA 083287
Procainamide HCl Capsules USP, 250 mg
Do.ANDA 084280
Procainamide HCl Capsules USP, 500 mg
Do.ANDA 084403
Procainamide HCl Capsules USP, 375 mg
Do.ANDA 084467
Reserpine and Hydrochlorothiazide Tablets USP, 0.125 mg/50 mg
Do.ANDA 085083
Diphenhydramine HCl Capsules USP, 50 mg
Do.ANDA 085140
Quinidine Sulfate Tablets USP, 200 mg
Do.ANDA 085173
Chlorothiazide Tablets USP, 250 mg
Do.ANDA 085180
Methocarbamol Tablets USP, 500 mg
Do.ANDA 085192
Methocarbamol Tablets USP, 750 mg
Do.ANDA 085597
Methylprednisolone Acetate Injectable Suspension USP, 20 mg/mL
Do.ANDA 086013
Statobex (phendimetrazine tartrate) Tablets USP, 35 mg
Teva Pharmaceuticals USA, Inc.ANDA 086029
Testosterone Cypionate Injection USP, 100 mg/mL
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.ANDA 086031
Isosorbide Dinitrate Sublingual Tablets USP, 5 mg
Do.( print page 131)ANDA 086034
Isosorbide Dinitrate Tablets USP, 5 mg
Do.ANDA 086188
Gerimal (ergoloid mesylates) Sublingual Tablets, 1 mg
Do.ANDA 086385
Nandrolone Decanoate Injection, 50 mg/mL
Do.ANDA 086562
Wigraine (ergotamine tartrate and caffeine) Tablets USP, 1 mg/100 mg
Organon USA, Inc., Subsidiary of Merck & Co., Inc., 2000 Galloping Hill Rd., Kenilworth, NJ 07033.ANDA 086742
Choledyl SA (oxtriphylline) Extended-Release Tablets, 600 mg
Warner Chilcott Co., LLC, Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.ANDA 086863
Chlorpromazine HCl Oral Concentrate USP, 100 mg/mL
Actavis Mid Atlantic, LLC, Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.ANDA 087233
Ergoloid Mesylates Sublingual Tablets USP, 0.5 mg
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.ANDA 087244
Ergoloid Mesylates Tablets USP, 1 mg
Do.ANDA 087318.
Tolbutamide Tablets USP, 500 mg
Do.ANDA 087727
Aminophylline Oral Solution USP, 105 mg/5 mL (Dye Free)
Actavis Mid Atlantic, LLC, Subsidiary of Teva Pharmaceuticals USA, Inc.ANDA 088128
Nandrolone Decanoate Injection, 200 mg/mL
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.ANDA 088337
Ergostat (ergotamine tartrate) Sublingual Tablets USP, 2 mg
Do.ANDA 088477
Thioridazine HCl Tablets USP, 15 mg
Do.ANDA 088561
Thioridazine HCl Tablets USP, 10 mg
Do.ANDA 088564
Thioridazine HCl Tablets USP, 100 mg
Do.ANDA 088724
Methyclothiazide Tablets USP, 5 mg
Do.ANDA 088734
Meclizine HCl Tablets, 25 mg
Pliva, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.ANDA 088769
Mepivacaine HCl Injection USP, 1%
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.ANDA 088770
Mepivacaine HCl Injection USP, 2%
Do.ANDA 088872
Thioridazine HCl Tablets USP, 200 mg
Do.ANDA 089026
Procainamide HCl Extended-Release Tablets USP, 250 mg
Do.ANDA 089027
Procainamide HCl Extended-Release Tablets USP, 500 mg
Do.ANDA 089530
Prochlorperazine Edisylate Injection USP, EQ 5 mg base/mL
Do.
 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