Parke-Davis, Subsidiary of Pfizer, Inc. et al.; Withdraw of Approval of 38 New Drug Applications and 43 Abbreviated New Drug Applications, 7738-7740 [2018-03607]

Download as PDF 7738 Federal Register / Vol. 83, No. 36 / Thursday, February 22, 2018 / Notices (i.e., the number of respondents, the number of recordkeepers, the number of NCIEs received, etc.) is derived from our records. The burden for this information collection has changed since the last OMB approval. We estimate an overall increase in burden that we attribute to an increase in the number of annual responses and records. Dated: February 15, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–03609 Filed 2–21–18; 8:45 am] Approval is withdrawn as of March 26, 2018. DEPARTMENT OF HEALTH AND HUMAN SERVICES DATES: Food and Drug Administration FOR FURTHER INFORMATION CONTACT: [Docket No. FDA–2018–N–0508] Parke-Davis, Subsidiary of Pfizer, Inc. et al.; Withdraw of Approval of 38 New Drug Applications and 43 Abbreviated New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is withdrawing approval of 38 new drug applications (NDAs) and 43 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. SUMMARY: BILLING CODE 4164–01–P Florine P. Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993–0002, 301– 796–3601. 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 § 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. SUPPLEMENTARY INFORMATION: TABLE 1 Application No. Drug Applicant NDA 010151 ...... Dilantin (phenytoin sodium) Injection USP, 50 milligrams (mg)/milliliter (mL). Zolyse (chymotrypsin) for Ophthalmic Solution, 750 units/vial Parke-Davis, Subsidiary of Pfizer, Inc., 235 East 42nd St., New York, NY 10017. Alcon Laboratories, Inc., 6201 S. Freeway, TC–45, Fort Worth, TX 76134–2099. Hospira Inc., 8401 W. 102nd St., Pleasant Prairie, WI 53158. NDA 011903 ...... NDA 012125 ...... NDA 012516 ...... NDA 016774 ...... NDA 016775 ...... NDA 016793 ...... NDA 016997 ...... NDA 017364 ...... NDA 017575 ...... NDA 017717 ...... NDA NDA NDA NDA 017869 017993 018052 018128 ...... ...... ...... ...... Carbocaine (mepivacaine hydrochloride (HCl)) Injection USP, 3%. Carbocaine with Neo-Cobefrin (mepivacaine HCl; levonordefrin) Injection USP, 2%; 0.05 mg/mL. Sansert (methysergide maleate) Tablets, 2 mg ...................... Serentil (mesoridazine besylate) Tablets, Equivalent to (EQ) 10 mg base, 25 mg base, 50 mg base, and 100 mg base. Serentil (mesoridazine besylate) Injection, EQ 25 mg base/ mL. Cytosar-U (cytarabine) for Injection USP, 100 mg/vial, 500 mg/vial, 1 gram (g)/vial, and 2 g/vial. Serentil (mesoridazine besylate) Oral Concentrate, EQ 25 mg base/mL. Aquatensen (methyclothiazide) Tablets USP, 5 mg ................ DTIC-Dome (dacarbazine) for Injection, 100 mg/vial and 200 mg/vial. Gyne-Lotrimin (clotrimazole) Vaginal Tablets, 100 mg ........... NDA 018418 ...... NDA 018439 ...... Funduscein-25 (fluorescein sodium) Injection, 25% ................ Hydergine (ergoloid mesylates) Tablets, 0.5 mg and 1 mg .... Gyne-Lotrimin (clotrimazole) Vaginal Cream, 1% ................... Ovcon-50 (norethindrone and ethinyl estradiol) Tablets USP (21-Day Regimen), 1 mg and 0.05 mg. Chlor-Trimeton (chlorpheniramine maleate and pseudoephedrine sulfate) Extended-Release Tablets, 8 mg and 120 mg. Hydergine (ergoloid mesylates) Oral Solution, 1 mg/mL ......... Multi-Vitamins Concentrate for Infusion, Injection ................... NDA 018471 ...... NDA 018517 ...... Ocuclear (oxymetazoline HCl) Ophthalmic Solution, 0.025% Metronidazole Tablets USP, 250 mg and 500 mg .................. NDA 018969 ...... NDA 020045 ...... Liposyn III 10% (soybean oil) Injection, 10% .......................... Shade UVAGuard (avobenzone, octinoxate, oxybenzone) Lotion, 3%/7.5%/3%. Gyne-Lotrimin Combination Pack (clotrimazole) Vaginal Cream and Vaginal Tablets, 1% and 100 mg. daltland on DSKBBV9HB2PROD with NOTICES NDA 018397 ...... NDA 020289 ...... VerDate Sep<11>2014 20:10 Feb 21, 2018 Jkt 244001 PO 00000 Frm 00085 Fmt 4703 Sfmt 4703 Novartis Pharmaceuticals Corp., One Health Pl., East Hanover, NJ 07936–1080. Do. Do. Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. Novartis Pharmaceuticals Corp. Meda Pharmaceuticals, Inc., 265 Davidson Ave., Suite 400, Somerset, NJ 08873. Bayer Healthcare Pharmaceuticals, Inc., 100 Bayer Blvd., Whippany, NJ 07981. Bayer HealthCare, LLC, 100 Bayer Blvd., P.O. Box 915, Whippany, NJ 07981–0915. Novartis Pharmaceuticals Corp. Do. Bayer HealthCare, LLC. Warner Chilcott Co., LLC, c/o Warner Chilcott (US), LLC, 100 Enterprise Dr., Rockaway, NJ 07866. Bayer HealthCare, LLC. Novartis Pharmaceuticals Corp. Watson Laboratories, Inc., Subsidiary of Teva ceuticals USA, Inc., 425 Privet Rd., Horsham, PA Bayer HealthCare, LLC. IVAX Pharmaceuticals, Inc., Subsidiary of Teva ceuticals USA, Inc., 425 Privet Rd., Horsham, PA Hospira, Inc. Bayer HealthCare, LLC. Do. E:\FR\FM\22FEN1.SGM 22FEN1 Pharma19044. Pharma19044. Federal Register / Vol. 83, No. 36 / Thursday, February 22, 2018 / Notices 7739 TABLE 1—Continued Application No. NDA NDA NDA NDA 020421 020499 020525 020526 ...... ...... ...... ...... NDA 020574 ...... NDA 020619 ...... NDA NDA NDA NDA NDA NDA 020665 020807 020888 020889 020890 021257 ...... ...... ...... ...... ...... ...... NDA 021711 ...... Drug Applicant Femstat-3 (butoconazole nitrate) Vaginal Cream, 2% ............ Actron (ketoprofen) Tablets, 12.5 mg ...................................... Gyne-Lotrimin 3 (clotrimazole) Vaginal Tablets, 200 mg ........ Gyne-Lotrimin 3 Combination Pack (clotrimazole) Vaginal Cream and Vaginal Tablets, 1% and 200 mg. Gyne-Lotrimin 3 (clotrimazole) Vaginal Cream, 2% ................ Betoptic Pilo (betaxolol HCl; pilocarpine HCl) Ophthalmic Suspension, EQ 0.25% base; 1.75%. Diovan (valsartan) Capsules, 80 mg and 160 mg ................... Refludan (lepirudin recombinant) for Injection, 50 mg/vial ...... Lotrimin AF (clotrimazole) Cream, 1% ..................................... Lotrimin AF (clotrimazole) Lotion, 1% ...................................... Lotrimin AF (clotrimazole) Topical Solution, 1% ...................... Travatan (travoprost) Ophthalmic Solution, 0.004% ................ ANDA 065057 .... Ablavar (gadofosveset trisodium) Injection, 2440 mg/10 mL and 3660 mg/15 mL. Poly-Pred (neomycin sulfate; polymyxin B sulfate; prednisolone acetate) Ophthalmic Suspension, EQ 0.35% base; 10,000 units/mL; 0.5%. Penicillin V Potassium for Oral Solution USP, EQ 125 mg base/5 mL and EQ 250 mg base/5 mL. Ampicillin Trihydrate for Oral Suspension, EQ 125 mg base/5 mL and EQ 250 mg base/5 mL. Tobramycin Sulfate Injection USP, EQ 40 mg base/mL (Pharmacy Bulk Package). Cefaclor Extended-Release Tablets, EQ 500 mg base .......... ANDA 071295 .... Atropine Injection, EQ 2 mg sulfate/0.7 mL ............................. ANDA 071536 .... ANDA 071690 .... Metoclopramide Tablets USP, EQ 5 mg base and EQ 10 mg base. N.E.E. 1/35 21-day (norethindrone and ethinyl estradiol) Tablets USP, 1 mg/0.035 mg. N.E.E. 1/35 28-day (norethindrone and ethinyl estradiol) Tablets USP, 1 mg/0.035 mg. Norcept-E 1/35 21-day (norethindrone and ethinyl estradiol) Tablets USP, 1 mg/0.035 mg. Norcept-E 1/35 28-day (norethindrone and ethinyl estradiol) Tablets USP, 1 mg/0.035 mg. Metoprolol Tartrate Tablets USP, 50 mg ................................. ANDA ANDA ANDA ANDA Metoprolol Tartrate Tablets USP, Atracurium Besylate Injection, 10 Atracurium Besylate Injection, 10 Etodolac Capsules USP, 300 mg NDA 050081 ...... ANDA 061758 .... ANDA 061980 .... ANDA 063116 .... ANDA 071541 .... ANDA 071542 .... ANDA 071545 .... ANDA 071546 .... 071691 074633 074639 074929 .... .... .... .... 100 mg ............................... mg/mL (Single-dose Vials) mg/mL (Abboject Syringe) ............................................ Famotidine Injection, 10 mg/mL ............................................... Midazolam HCl Syrup, EQ 2 mg base/mL .............................. ANDA 083140 .... Hydrocortisone Tablets, 20 mg ................................................ ANDA ANDA ANDA ANDA ANDA ANDA .... .... .... .... .... .... Isoniazid Tablets, 300 mg ........................................................ Diphenhydramine HCl Capsules, 25 mg ................................. Isoniazid Tablets, 100 mg ........................................................ Meprobamate Tablets, 200 mg ................................................ Pentobarbital Sodium Tablets, 100 mg ................................... Phentermine HCl Capsules USP, 30 mg ................................. ANDA 084589 .... ANDA 084915 .... ANDA 085499 .... daltland on DSKBBV9HB2PROD with NOTICES ANDA 075870 .... ANDA 076058 .... Meprobamate Tablets, 400 mg ................................................ Folic Acid Tablets, 1 mg .......................................................... Potassium Chloride for Injection Concentrate USP, 2 milliequivalents/mL. Dimenhydrinate Tablets, 50 mg ............................................... Phendimetrazine Tartrate Tablets, 35 mg ............................... Brompheniramine Maleate Tablets, 4 mg ................................ Meclizine HCl Tablets, 25 mg (Chewable) .............................. Polaramine (dexchlorpheniramine maleate) Tablets, 2 mg ..... ANDA ANDA ANDA ANDA ANDA 083633 083634 084050 084220 084238 084487 085985 086020 086187 086392 086835 .... .... .... .... .... ANDA 086837 .... VerDate Sep<11>2014 Polaramine (dexchlorpheniramine maleate) Syrup, 2 mg/5 mL. 20:10 Feb 21, 2018 Jkt 244001 PO 00000 Frm 00086 Fmt 4703 Sfmt 4703 Do. Do. Do. Do. Do. Alcon Laboratories, Inc. Novartis Pharmaceuticals Corp. Bayer HealthCare Pharmaceuticals, Inc. Bayer HealthCare, LLC. Do. Do. Alcon Pharmaceuticals, Ltd., 6201 S. Freeway, TC–45, Fort Worth, TX 76134. Lantheus Medical Imaging, Inc., 331 Treble Cove Rd., Building 300–2, North Billerica, MA 01862. Allergan, Inc., 2525 Dupont Dr., P.O. Box 19534, Irvine, CA 92623–9534. Purepac Pharm., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. Do. Hospira, Inc. World Gen, LLC, 120 Route 17 North, Suite 127, Paramus, NJ 07652. AbbVie, Inc., Dept. PA77/Bldg. AP30, 1 N. Waukegan Rd., North Chicago, IL 60064. Sun Pharmaceutical Industries, Inc., 2 Independence Way, Princeton, NJ 08540. LPI Holdings, Inc., 5000 Plaza on the Lake, No. 270, Austin, TX 78746. Do. Janssen Pharmaceuticals, Inc., 1000 U.S. Highway 202, P.O. Box 300, Raritan, NJ 08869–0602. Do. Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. Do. Hospira, Inc. Do. ECI Pharmaceuticals, LLC, 5311 NW 35th Terrace, Fort Lauderdale, FL 33309. Hospira, Inc. Sun Pharmaceutical Industries, Ltd., c/o Sun Pharmaceutical Industries, Inc., 2 Independence Way, Princeton, NJ 08540. Nexgen Pharma, Inc., 46 Corporate Park, Suite 200, Irvine, CA 92606. Sun Pharmaceutical Industries, Inc. Nexgen Pharma, Inc. Do. Do. Do. Upsher-Smith Laboratories, LLC, 301 South Cherokee St., Denver, CO 80223. Nexgen Pharma, Inc. Do. Baxter Healthcare Corp., 1620 Waukegan Rd., McGaw Park, IL 60085. Nexgen Pharma, Inc. Do. Do. Do. Merck Sharp & Dohme Corp., Subsidiary of Merck & Co., Inc. Do. E:\FR\FM\22FEN1.SGM 22FEN1 7740 Federal Register / Vol. 83, No. 36 / Thursday, February 22, 2018 / Notices TABLE 1—Continued Application No. Drug Applicant ANDA 087766 .... Thioridazine HCl Oral Concentrate, 30 mg/mL ....................... ANDA 087858 .... Isoetharine Mesylate Metered Dose Inhaler, 0.34 mg/inhalation. Phentermine HCl Capsules USP, 30 mg ................................. Hydroxyzine HCl Tablets USP, 10 mg .................................... Hydroxyzine HCl Tablets USP, 25 mg .................................... Hydroxyzine HCl Tablets USP, 50 mg .................................... Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/15 mg. Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/30 mg. Diphenhydramine HCl Capsules, 50 mg ................................. Furosemide Tablets USP, 20 mg, 40 mg, and 80 mg ............ Dexilant Solutab (dexlansoprazole) Delayed-Release Orally Disintegrating Tablets, 30 mg. Alpharma US Pharms., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. Do. ANDA ANDA ANDA ANDA ANDA 088430 089381 089382 089383 089481 .... .... .... .... .... ANDA 089482 .... ANDA 089489 .... ANDA 091258 .... NDA 208056 ...... 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 15, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–03607 Filed 2–21–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–0405] Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Recall Authority AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each daltland on DSKBBV9HB2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 20:10 Feb 21, 2018 Jkt 244001 Upsher-Smith Laboratories, LLC. Sun Pharmaceutical Industries, Inc. Do. Do. American Therapeutics, Inc., 89 Carlough Rd., Bohemia, NY 11716. Do. Sun Pharmaceutical Industries, Inc. Do. Takeda Pharmaceuticals U.S.A., Inc., One Takeda Pkwy., Deerfield, IL 60015. proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection related to Medical Device Recall Authority. DATES: Submit either electronic or written comments on the collection of information by April 23, 2018. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before April 23, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of April 23, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that PO 00000 Frm 00087 Fmt 4703 Sfmt 4703 identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2018–N–0405 for ‘‘Medical Device Recall Authority.’’ Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS E:\FR\FM\22FEN1.SGM 22FEN1

Agencies

[Federal Register Volume 83, Number 36 (Thursday, February 22, 2018)]
[Notices]
[Pages 7738-7740]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-03607]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0508]


Parke-Davis, Subsidiary of Pfizer, Inc. et al.; Withdraw of 
Approval of 38 New Drug Applications and 43 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 38 new drug applications (NDAs) and 43 
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 March 26, 2018.

FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301-
796-3601.

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.

                                 Table 1
------------------------------------------------------------------------
    Application No.                Drug                  Applicant
------------------------------------------------------------------------
NDA 010151.............  Dilantin (phenytoin      Parke-Davis,
                          sodium) Injection USP,   Subsidiary of Pfizer,
                          50 milligrams (mg)/      Inc., 235 East 42nd
                          milliliter (mL).         St., New York, NY
                                                   10017.
NDA 011903.............  Zolyse (chymotrypsin)    Alcon Laboratories,
                          for Ophthalmic           Inc., 6201 S.
                          Solution, 750 units/     Freeway, TC-45, Fort
                          vial.                    Worth, TX 76134-2099.
NDA 012125.............  Carbocaine (mepivacaine  Hospira Inc., 8401 W.
                          hydrochloride (HCl))     102nd St., Pleasant
                          Injection USP, 3%.       Prairie, WI 53158.
                         Carbocaine with Neo-
                          Cobefrin (mepivacaine
                          HCl; levonordefrin)
                          Injection USP, 2%;
                          0.05 mg/mL.
NDA 012516.............  Sansert (methysergide    Novartis
                          maleate) Tablets, 2 mg.  Pharmaceuticals
                                                   Corp., One Health
                                                   Pl., East Hanover, NJ
                                                   07936-1080.
NDA 016774.............  Serentil (mesoridazine    Do.
                          besylate) Tablets,
                          Equivalent to (EQ) 10
                          mg base, 25 mg base,
                          50 mg base, and 100 mg
                          base.
NDA 016775.............  Serentil (mesoridazine    Do.
                          besylate) Injection,
                          EQ 25 mg base/mL.
NDA 016793.............  Cytosar-U (cytarabine)   Teva Pharmaceuticals
                          for Injection USP, 100   USA, Inc., 425 Privet
                          mg/vial, 500 mg/vial,    Rd., Horsham, PA
                          1 gram (g)/vial, and 2   19044.
                          g/vial.
NDA 016997.............  Serentil (mesoridazine   Novartis
                          besylate) Oral           Pharmaceuticals Corp.
                          Concentrate, EQ 25 mg
                          base/mL.
NDA 017364.............  Aquatensen               Meda Pharmaceuticals,
                          (methyclothiazide)       Inc., 265 Davidson
                          Tablets USP, 5 mg.       Ave., Suite 400,
                                                   Somerset, NJ 08873.
NDA 017575.............  DTIC-Dome (dacarbazine)  Bayer Healthcare
                          for Injection, 100 mg/   Pharmaceuticals,
                          vial and 200 mg/vial.    Inc., 100 Bayer
                                                   Blvd., Whippany, NJ
                                                   07981.
NDA 017717.............  Gyne-Lotrimin            Bayer HealthCare, LLC,
                          (clotrimazole) Vaginal   100 Bayer Blvd., P.O.
                          Tablets, 100 mg.         Box 915, Whippany, NJ
                                                   07981-0915.
NDA 017869.............  Funduscein-25            Novartis
                          (fluorescein sodium)     Pharmaceuticals Corp.
                          Injection, 25%.
NDA 017993.............  Hydergine (ergoloid       Do.
                          mesylates) Tablets,
                          0.5 mg and 1 mg.
NDA 018052.............  Gyne-Lotrimin            Bayer HealthCare, LLC.
                          (clotrimazole) Vaginal
                          Cream, 1%.
NDA 018128.............  Ovcon-50 (norethindrone  Warner Chilcott Co.,
                          and ethinyl estradiol)   LLC, c/o Warner
                          Tablets USP (21-Day      Chilcott (US), LLC,
                          Regimen), 1 mg and       100 Enterprise Dr.,
                          0.05 mg.                 Rockaway, NJ 07866.
NDA 018397.............  Chlor-Trimeton           Bayer HealthCare, LLC.
                          (chlorpheniramine
                          maleate and
                          pseudoephedrine
                          sulfate) Extended-
                          Release Tablets, 8 mg
                          and 120 mg.
NDA 018418.............  Hydergine (ergoloid      Novartis
                          mesylates) Oral          Pharmaceuticals Corp.
                          Solution, 1 mg/mL.
NDA 018439.............  Multi-Vitamins           Watson Laboratories,
                          Concentrate for          Inc., Subsidiary of
                          Infusion, Injection.     Teva Pharmaceuticals
                                                   USA, Inc., 425 Privet
                                                   Rd., Horsham, PA
                                                   19044.
NDA 018471.............  Ocuclear (oxymetazoline  Bayer HealthCare, LLC.
                          HCl) Ophthalmic
                          Solution, 0.025%.
NDA 018517.............  Metronidazole Tablets    IVAX Pharmaceuticals,
                          USP, 250 mg and 500 mg.  Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc., 425 Privet
                                                   Rd., Horsham, PA
                                                   19044.
NDA 018969.............  Liposyn III 10%          Hospira, Inc.
                          (soybean oil)
                          Injection, 10%.
NDA 020045.............  Shade UVAGuard           Bayer HealthCare, LLC.
                          (avobenzone,
                          octinoxate,
                          oxybenzone) Lotion, 3%/
                          7.5%/3%.
NDA 020289.............  Gyne-Lotrimin             Do.
                          Combination Pack
                          (clotrimazole) Vaginal
                          Cream and Vaginal
                          Tablets, 1% and 100 mg.

[[Page 7739]]

 
NDA 020421.............  Femstat-3 (butoconazole   Do.
                          nitrate) Vaginal
                          Cream, 2%.
NDA 020499.............  Actron (ketoprofen)       Do.
                          Tablets, 12.5 mg.
NDA 020525.............  Gyne-Lotrimin 3           Do.
                          (clotrimazole) Vaginal
                          Tablets, 200 mg.
NDA 020526.............  Gyne-Lotrimin 3           Do.
                          Combination Pack
                          (clotrimazole) Vaginal
                          Cream and Vaginal
                          Tablets, 1% and 200 mg.
NDA 020574.............  Gyne-Lotrimin 3           Do.
                          (clotrimazole) Vaginal
                          Cream, 2%.
NDA 020619.............  Betoptic Pilo            Alcon Laboratories,
                          (betaxolol HCl;          Inc.
                          pilocarpine HCl)
                          Ophthalmic Suspension,
                          EQ 0.25% base; 1.75%.
NDA 020665.............  Diovan (valsartan)       Novartis
                          Capsules, 80 mg and      Pharmaceuticals Corp.
                          160 mg.
NDA 020807.............  Refludan (lepirudin      Bayer HealthCare
                          recombinant) for         Pharmaceuticals, Inc.
                          Injection, 50 mg/vial.
NDA 020888.............  Lotrimin AF              Bayer HealthCare, LLC.
                          (clotrimazole) Cream,
                          1%.
NDA 020889.............  Lotrimin AF               Do.
                          (clotrimazole) Lotion,
                          1%.
NDA 020890.............  Lotrimin AF               Do.
                          (clotrimazole) Topical
                          Solution, 1%.
NDA 021257.............  Travatan (travoprost)    Alcon Pharmaceuticals,
                          Ophthalmic Solution,     Ltd., 6201 S.
                          0.004%.                  Freeway, TC-45, Fort
                                                   Worth, TX 76134.
NDA 021711.............  Ablavar (gadofosveset    Lantheus Medical
                          trisodium) Injection,    Imaging, Inc., 331
                          2440 mg/10 mL and 3660   Treble Cove Rd.,
                          mg/15 mL.                Building 300-2, North
                                                   Billerica, MA 01862.
NDA 050081.............  Poly-Pred (neomycin      Allergan, Inc., 2525
                          sulfate; polymyxin B     Dupont Dr., P.O. Box
                          sulfate; prednisolone    19534, Irvine, CA
                          acetate) Ophthalmic      92623-9534.
                          Suspension, EQ 0.35%
                          base; 10,000 units/mL;
                          0.5%.
ANDA 061758............  Penicillin V Potassium   Purepac Pharm.,
                          for Oral Solution USP,   Subsidiary of Teva
                          EQ 125 mg base/5 mL      Pharmaceuticals USA,
                          and EQ 250 mg base/5     Inc., 425 Privet Rd.,
                          mL.                      Horsham, PA 19044.
ANDA 061980............  Ampicillin Trihydrate     Do.
                          for Oral Suspension,
                          EQ 125 mg base/5 mL
                          and EQ 250 mg base/5
                          mL.
ANDA 063116............  Tobramycin Sulfate       Hospira, Inc.
                          Injection USP, EQ 40
                          mg base/mL (Pharmacy
                          Bulk Package).
ANDA 065057............  Cefaclor Extended-       World Gen, LLC, 120
                          Release Tablets, EQ      Route 17 North, Suite
                          500 mg base.             127, Paramus, NJ
                                                   07652.
ANDA 071295............  Atropine Injection, EQ   AbbVie, Inc., Dept.
                          2 mg sulfate/0.7 mL.     PA77/Bldg. AP30, 1 N.
                                                   Waukegan Rd., North
                                                   Chicago, IL 60064.
ANDA 071536............  Metoclopramide Tablets   Sun Pharmaceutical
                          USP, EQ 5 mg base and    Industries, Inc., 2
                          EQ 10 mg base.           Independence Way,
                                                   Princeton, NJ 08540.
ANDA 071541............  N.E.E. 1/35 21-day       LPI Holdings, Inc.,
                          (norethindrone and       5000 Plaza on the
                          ethinyl estradiol)       Lake, No. 270,
                          Tablets USP, 1 mg/       Austin, TX 78746.
                          0.035 mg.
ANDA 071542............  N.E.E. 1/35 28-day        Do.
                          (norethindrone and
                          ethinyl estradiol)
                          Tablets USP, 1 mg/
                          0.035 mg.
ANDA 071545............  Norcept-E 1/35 21-day    Janssen
                          (norethindrone and       Pharmaceuticals,
                          ethinyl estradiol)       Inc., 1000 U.S.
                          Tablets USP, 1 mg/       Highway 202, P.O. Box
                          0.035 mg.                300, Raritan, NJ
                                                   08869-0602.
ANDA 071546............  Norcept-E 1/35 28-day     Do.
                          (norethindrone and
                          ethinyl estradiol)
                          Tablets USP, 1 mg/
                          0.035 mg.
ANDA 071690............  Metoprolol Tartrate      Watson Laboratories,
                          Tablets USP, 50 mg.      Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 071691............  Metoprolol Tartrate       Do.
                          Tablets USP, 100 mg.
ANDA 074633............  Atracurium Besylate      Hospira, Inc.
                          Injection, 10 mg/mL
                          (Single-dose Vials).
ANDA 074639............  Atracurium Besylate       Do.
                          Injection, 10 mg/mL
                          (Abboject Syringe).
ANDA 074929............  Etodolac Capsules USP,   ECI Pharmaceuticals,
                          300 mg.                  LLC, 5311 NW 35th
                                                   Terrace, Fort
                                                   Lauderdale, FL 33309.
ANDA 075870............  Famotidine Injection,    Hospira, Inc.
                          10 mg/mL.
ANDA 076058............  Midazolam HCl Syrup, EQ  Sun Pharmaceutical
                          2 mg base/mL.            Industries, Ltd., c/o
                                                   Sun Pharmaceutical
                                                   Industries, Inc., 2
                                                   Independence Way,
                                                   Princeton, NJ 08540.
ANDA 083140............  Hydrocortisone Tablets,  Nexgen Pharma, Inc.,
                          20 mg.                   46 Corporate Park,
                                                   Suite 200, Irvine, CA
                                                   92606.
ANDA 083633............  Isoniazid Tablets, 300   Sun Pharmaceutical
                          mg.                      Industries, Inc.
ANDA 083634............  Diphenhydramine HCl      Nexgen Pharma, Inc.
                          Capsules, 25 mg.
ANDA 084050............  Isoniazid Tablets, 100    Do.
                          mg.
ANDA 084220............  Meprobamate Tablets,      Do.
                          200 mg.
ANDA 084238............  Pentobarbital Sodium      Do.
                          Tablets, 100 mg.
ANDA 084487............  Phentermine HCl          Upsher-Smith
                          Capsules USP, 30 mg.     Laboratories, LLC,
                                                   301 South Cherokee
                                                   St., Denver, CO
                                                   80223.
ANDA 084589............  Meprobamate Tablets,     Nexgen Pharma, Inc.
                          400 mg.
ANDA 084915............  Folic Acid Tablets, 1     Do.
                          mg.
ANDA 085499............  Potassium Chloride for   Baxter Healthcare
                          Injection Concentrate    Corp., 1620 Waukegan
                          USP, 2                   Rd., McGaw Park, IL
                          milliequivalents/mL.     60085.
ANDA 085985............  Dimenhydrinate Tablets,  Nexgen Pharma, Inc.
                          50 mg.
ANDA 086020............  Phendimetrazine           Do.
                          Tartrate Tablets, 35
                          mg.
ANDA 086187............  Brompheniramine Maleate   Do.
                          Tablets, 4 mg.
ANDA 086392............  Meclizine HCl Tablets,    Do.
                          25 mg (Chewable).
ANDA 086835............  Polaramine               Merck Sharp & Dohme
                          (dexchlorpheniramine     Corp., Subsidiary of
                          maleate) Tablets, 2 mg.  Merck & Co., Inc.
ANDA 086837............  Polaramine                Do.
                          (dexchlorpheniramine
                          maleate) Syrup, 2 mg/5
                          mL.

[[Page 7740]]

 
ANDA 087766............  Thioridazine HCl Oral    Alpharma US Pharms.,
                          Concentrate, 30 mg/mL.   Subsidiary of Teva
                                                   Pharmaceuticals USA,
                                                   Inc., 425 Privet Rd.,
                                                   Horsham, PA 19044.
ANDA 087858............  Isoetharine Mesylate      Do.
                          Metered Dose Inhaler,
                          0.34 mg/inhalation.
ANDA 088430............  Phentermine HCl          Upsher-Smith
                          Capsules USP, 30 mg.     Laboratories, LLC.
ANDA 089381............  Hydroxyzine HCl Tablets  Sun Pharmaceutical
                          USP, 10 mg.              Industries, Inc.
ANDA 089382............  Hydroxyzine HCl Tablets   Do.
                          USP, 25 mg.
ANDA 089383............  Hydroxyzine HCl Tablets   Do.
                          USP, 50 mg.
ANDA 089481............  Acetaminophen and        American Therapeutics,
                          Codeine Phosphate        Inc., 89 Carlough
                          Tablets USP, 300 mg/15   Rd., Bohemia, NY
                          mg.                      11716.
ANDA 089482............  Acetaminophen and         Do.
                          Codeine Phosphate
                          Tablets USP, 300 mg/30
                          mg.
ANDA 089489............  Diphenhydramine HCl      Sun Pharmaceutical
                          Capsules, 50 mg.         Industries, Inc.
ANDA 091258............  Furosemide Tablets USP,   Do.
                          20 mg, 40 mg, and 80
                          mg.
NDA 208056.............  Dexilant Solutab         Takeda Pharmaceuticals
                          (dexlansoprazole)        U.S.A., Inc., One
                          Delayed-Release Orally   Takeda Pkwy.,
                          Disintegrating           Deerfield, IL 60015.
                          Tablets, 30 mg.
------------------------------------------------------------------------

    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 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03607 Filed 2-21-18; 8:45 am]
 BILLING CODE 4164-01-P

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