128 Federal Register / Vol. 83, No. 1 / Tuesday, January 2, 2018 / Notices 

https://www.regulations.gov or at the 

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the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

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FOR FURTHER INFORMATION CONTACT: 

Moon Hee V. Choi, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, Rm. 2417, 

Silver Spring, MD 20993–0002, 301– 

796–9001, Fax: 301–847–8533, email: 

AADPAC@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

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AdvisoryCommittees/default.htm and 

scroll down to the appropriate advisory 

committee meeting link, or call the 

advisory committee information line to 

learn about possible modifications 

before coming to the meeting. 

SUPPLEMENTARY INFORMATION: 

Agenda: The committees will be 

asked to discuss new drug application 

(NDA) 209257, proposed tradename, 

HYDEXOR, a fixed-dose combination 

oral tablet, submitted by Charleston 

Laboratories, Inc., that contains 

hydrocodone, acetaminophen, and 

promethazine, for the short-term 

management of acute pain severe 

enough to require an opioid analgesic 

while preventing and reducing opioidinduced nausea and vomiting. The 

committees will also be asked to discuss 

the abuse potential of this non-abusedeterrent product and whether it should 

be approved. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its website prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s website after 

the meeting. Background material is 

available at https://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committees. Written 

submissions may be made to the contact 

person on or before January 31, 2018. 

Oral presentations from the public will 

be scheduled between approximately 

10:15 a.m. and 11:15 a.m. Those 

individuals interested in making formal 

oral presentations should notify the 

contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before January 23, 2018. Time 

allotted for each presentation may be 

limited. If the number of registrants 

requesting to speak is greater than can 

be reasonably accommodated during the 

scheduled open public hearing session, 

FDA may conduct a lottery to determine 

the speakers for the scheduled open 

public hearing session. The contact 

person will notify interested persons 

regarding their request to speak by 

January 24, 2018. 

Persons attending FDA’s advisory 

committee meetings are advised that 

FDA is not responsible for providing 

access to electrical outlets. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Moon Hee V. 

Choi at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: December 26, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–28250 Filed 12–29–17; 8:45 am] 

BILLING CODE 4164–01–P 

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. 

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, 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 1 / Tuesday, January 2, 2018 / Notices 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 Applicant 

ANDA 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. 


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130 Federal Register / Vol. 83, No. 1 / Tuesday, January 2, 2018 / Notices 

TABLE 1—Continued 

Application 

No. Drug Applicant 

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. 


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Federal Register / Vol. 83, No. 1 / Tuesday, January 2, 2018 / Notices 131 

TABLE 1—Continued 

Application 

No. Drug Applicant 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–5715] 

Watson Laboratories, Inc., and Barr 

Laboratories, Inc., Subsidiaries of Teva 

Pharmaceuticals USA, Inc.; Withdrawal 

of Approval of 54 Abbreviated New 

Drug Applications; Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; correction. 

SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

notice that appeared in the Federal 

Register of October 24, 2017. The 

document announced the withdrawal of 

approval of 54 abbreviated new drug 

applications (ANDAs) from two 

applicants, effective November 24, 2017. 

The notice inadvertently announced the 

withdrawal of approval for ANDA 

087296 for Chlorthalidone Tablets USP, 

25 milligrams, held by Watson 

Laboratories, Inc., a subsidiary of Teva 

Pharmaceuticals USA, Inc., 425 Privet 

Rd., Horsham, PA 19044. FDA confirms 

that the approval of ANDA 087296 is 

still in effect. 

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. 

SUPPLEMENTARY INFORMATION: In FR Doc. 

2017–23046, appearing on page 49214 

in the Federal Register of Tuesday, 

October 24, 2017, the following 

correction is made: 

1. On page 49215, in table 1, the entry 

for ANDA 087296 is removed. 

Dated: December 26, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–28253 Filed 12–29–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–1846] 

Labeling for Combined Hormonal 

Contraceptives; Draft Guidance for 

Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 


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