83_FR_7774 83 FR 7738 - Parke-Davis, Subsidiary of Pfizer, Inc. et al.; Withdraw of Approval of 38 New Drug Applications and 43 Abbreviated New Drug Applications

83 FR 7738 - Parke-Davis, Subsidiary of Pfizer, Inc. et al.; Withdraw of Approval of 38 New Drug Applications and 43 Abbreviated New Drug Applications

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 36 (February 22, 2018)

Page Range7738-7740
FR Document2018-03607

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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

Federal Register, Volume 83 Issue 36 (Thursday, February 22, 2018) 
[Federal Register Volume 83, Number 36 (Thursday, February 22, 2018)]
[Notices]
[Pages 7738-7740]
From the Federal Register Online  [www.thefederalregister.org]
[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of the applications be withdrawn.

DATES: Approval is withdrawn as of March 26, 2018.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

7738 Federal Register / Vol. 83, No. 36 / Thursday, February 22, 2018 / Notices (i.e., the number of respondents, the DEPARTMENT OF HEALTH AND DATES:Approval is withdrawn as of number of recordkeepers, the number of HUMAN SERVICES March 26, 2018. NCIEs received, etc.) is derived from our Food and Drug Administration FOR FURTHER INFORMATION CONTACT: records. The burden for this information Florine P. Purdie, Center for Drug collection has changed since the last [Docket No. FDA–2018–N–0508] Evaluation and Research, Food and OMB approval. We estimate an overall Parke-Davis, Subsidiary of Pfizer, Inc. Drug Administration, 10903 New increase in burden that we attribute to et al.; Withdraw of Approval of 38 New Hampshire Ave., Bldg. 51, Rm. 6248, an increase in the number of annual Drug Applications and 43 Abbreviated Silver Spring, MD 20993–0002, 301– responses and records. New Drug Applications 796–3601. Dated: February 15, 2018. AGENCY: Food and Drug Administration, SUPPLEMENTARY INFORMATION: The Leslie Kux, HHS. holders of the applications listed in the Associate Commissioner for Policy. table have informed FDA that these drug ACTION: Notice. [FR Doc. 2018–03609 Filed 2–21–18; 8:45 am] products are no longer marketed and BILLING CODE 4164–01–P SUMMARY: The Food and Drug have requested that FDA withdraw Administration (FDA or Agency) is approval of the applications under the withdrawing approval of 38 new drug process in § 314.150(c) (21 CFR applications (NDAs) and 43 abbreviated 314.150(c)). The applicants have also, new drug applications (ANDAs) from by their requests, waived their multiple applicants. The holders of the opportunity for a hearing. Withdrawal applications notified the Agency in of approval of an application or writing that the drug products were no abbreviated application under longer marketed and requested that the § 314.150(c) is without prejudice to approval of the applications be withdrawn. refiling. TABLE 1 Application No. Drug Applicant NDA 010151 ...... Dilantin (phenytoin sodium) Injection USP, 50 milligrams Parke-Davis, Subsidiary of Pfizer, Inc., 235 East 42nd St., (mg)/milliliter (mL). New York, NY 10017. NDA 011903 ...... Zolyse (chymotrypsin) for Ophthalmic Solution, 750 units/vial Alcon Laboratories, Inc., 6201 S. Freeway, TC–45, Fort Worth, TX 76134–2099. NDA 012125 ...... Carbocaine (mepivacaine hydrochloride (HCl)) Injection USP, Hospira Inc., 8401 W. 102nd St., Pleasant Prairie, WI 53158. 3%. Carbocaine with Neo-Cobefrin (mepivacaine HCl; levonordefrin) Injection USP, 2%; 0.05 mg/mL. NDA 012516 ...... Sansert (methysergide maleate) Tablets, 2 mg ...................... Novartis Pharmaceuticals Corp., One Health Pl., East Han- over, NJ 07936–1080. NDA 016774 ...... Serentil (mesoridazine besylate) Tablets, Equivalent to (EQ) Do. 10 mg base, 25 mg base, 50 mg base, and 100 mg base. NDA 016775 ...... Serentil (mesoridazine besylate) Injection, EQ 25 mg base/ Do. mL. NDA 016793 ...... Cytosar-U (cytarabine) for Injection USP, 100 mg/vial, 500 Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, mg/vial, 1 gram (g)/vial, and 2 g/vial. PA 19044. NDA 016997 ...... Serentil (mesoridazine besylate) Oral Concentrate, EQ 25 Novartis Pharmaceuticals Corp. mg base/mL. NDA 017364 ...... Aquatensen (methyclothiazide) Tablets USP, 5 mg ................ Meda Pharmaceuticals, Inc., 265 Davidson Ave., Suite 400, Somerset, NJ 08873. NDA 017575 ...... DTIC-Dome (dacarbazine) for Injection, 100 mg/vial and 200 Bayer Healthcare Pharmaceuticals, Inc., 100 Bayer Blvd., mg/vial. Whippany, NJ 07981. NDA 017717 ...... Gyne-Lotrimin (clotrimazole) Vaginal Tablets, 100 mg ........... Bayer HealthCare, LLC, 100 Bayer Blvd., P.O. Box 915, Whippany, NJ 07981–0915. NDA 017869 ...... Funduscein-25 (fluorescein sodium) Injection, 25% ................ Novartis Pharmaceuticals Corp. NDA 017993 ...... Hydergine (ergoloid mesylates) Tablets, 0.5 mg and 1 mg .... Do. NDA 018052 ...... Gyne-Lotrimin (clotrimazole) Vaginal Cream, 1% ................... Bayer HealthCare, LLC. NDA 018128 ...... Ovcon-50 (norethindrone and ethinyl estradiol) Tablets USP Warner Chilcott Co., LLC, c/o Warner Chilcott (US), LLC, (21-Day Regimen), 1 mg and 0.05 mg. 100 Enterprise Dr., Rockaway, NJ 07866. NDA 018397 ...... Chlor-Trimeton (chlorpheniramine maleate and Bayer HealthCare, LLC. pseudoephedrine sulfate) Extended-Release Tablets, 8 mg and 120 mg. NDA 018418 ...... Hydergine (ergoloid mesylates) Oral Solution, 1 mg/mL ......... Novartis Pharmaceuticals Corp. NDA 018439 ...... Multi-Vitamins Concentrate for Infusion, Injection ................... Watson Laboratories, Inc., Subsidiary of Teva Pharma- ceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. daltland on DSKBBV9HB2PROD with NOTICES NDA 018471 ...... Ocuclear (oxymetazoline HCl) Ophthalmic Solution, 0.025% Bayer HealthCare, LLC. NDA 018517 ...... Metronidazole Tablets USP, 250 mg and 500 mg .................. IVAX Pharmaceuticals, Inc., Subsidiary of Teva Pharma- ceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. NDA 018969 ...... Liposyn III 10% (soybean oil) Injection, 10% .......................... Hospira, Inc. NDA 020045 ...... Shade UVAGuard (avobenzone, octinoxate, oxybenzone) Lo- Bayer HealthCare, LLC. tion, 3%/7.5%/3%. NDA 020289 ...... Gyne-Lotrimin Combination Pack (clotrimazole) Vaginal Do. Cream and Vaginal Tablets, 1% and 100 mg. VerDate Sep<11>2014 20:10 Feb 21, 2018 Jkt 244001 PO 00000 Frm 00085 Fmt 4703 Sfmt 4703 E:\FR\FM\22FEN1.SGM 22FEN1

Federal Register / Vol. 83, No. 36 / Thursday, February 22, 2018 / Notices 7739 TABLE 1—Continued Application No. Drug Applicant NDA 020421 ...... Femstat-3 (butoconazole nitrate) Vaginal Cream, 2% ............ Do. NDA 020499 ...... Actron (ketoprofen) Tablets, 12.5 mg ...................................... Do. NDA 020525 ...... Gyne-Lotrimin 3 (clotrimazole) Vaginal Tablets, 200 mg ........ Do. NDA 020526 ...... Gyne-Lotrimin 3 Combination Pack (clotrimazole) Vaginal Do. Cream and Vaginal Tablets, 1% and 200 mg. NDA 020574 ...... Gyne-Lotrimin 3 (clotrimazole) Vaginal Cream, 2% ................ Do. NDA 020619 ...... Betoptic Pilo (betaxolol HCl; pilocarpine HCl) Ophthalmic Alcon Laboratories, Inc. Suspension, EQ 0.25% base; 1.75%. NDA 020665 ...... Diovan (valsartan) Capsules, 80 mg and 160 mg ................... Novartis Pharmaceuticals Corp. NDA 020807 ...... Refludan (lepirudin recombinant) for Injection, 50 mg/vial ...... Bayer HealthCare Pharmaceuticals, Inc. NDA 020888 ...... Lotrimin AF (clotrimazole) Cream, 1% ..................................... Bayer HealthCare, LLC. NDA 020889 ...... Lotrimin AF (clotrimazole) Lotion, 1% ...................................... Do. NDA 020890 ...... Lotrimin AF (clotrimazole) Topical Solution, 1% ...................... Do. NDA 021257 ...... Travatan (travoprost) Ophthalmic Solution, 0.004% ................ Alcon Pharmaceuticals, Ltd., 6201 S. Freeway, TC–45, Fort Worth, TX 76134. NDA 021711 ...... Ablavar (gadofosveset trisodium) Injection, 2440 mg/10 mL Lantheus Medical Imaging, Inc., 331 Treble Cove Rd., Build- and 3660 mg/15 mL. ing 300–2, North Billerica, MA 01862. NDA 050081 ...... Poly-Pred (neomycin sulfate; polymyxin B sulfate; prednis- Allergan, Inc., 2525 Dupont Dr., P.O. Box 19534, Irvine, CA olone acetate) Ophthalmic Suspension, EQ 0.35% base; 92623–9534. 10,000 units/mL; 0.5%. ANDA 061758 .... Penicillin V Potassium for Oral Solution USP, EQ 125 mg Purepac Pharm., Subsidiary of Teva Pharmaceuticals USA, base/5 mL and EQ 250 mg base/5 mL. Inc., 425 Privet Rd., Horsham, PA 19044. ANDA 061980 .... Ampicillin Trihydrate for Oral Suspension, EQ 125 mg base/5 Do. mL and EQ 250 mg base/5 mL. ANDA 063116 .... Tobramycin Sulfate Injection USP, EQ 40 mg base/mL Hospira, Inc. (Pharmacy Bulk Package). ANDA 065057 .... Cefaclor Extended-Release Tablets, EQ 500 mg base .......... World Gen, LLC, 120 Route 17 North, Suite 127, Paramus, NJ 07652. ANDA 071295 .... Atropine Injection, EQ 2 mg sulfate/0.7 mL ............................. AbbVie, Inc., Dept. PA77/Bldg. AP30, 1 N. Waukegan Rd., North Chicago, IL 60064. ANDA 071536 .... Metoclopramide Tablets USP, EQ 5 mg base and EQ 10 mg Sun Pharmaceutical Industries, Inc., 2 Independence Way, base. Princeton, NJ 08540. ANDA 071541 .... N.E.E. 1/35 21-day (norethindrone and ethinyl estradiol) Tab- LPI Holdings, Inc., 5000 Plaza on the Lake, No. 270, Austin, lets USP, 1 mg/0.035 mg. TX 78746. ANDA 071542 .... N.E.E. 1/35 28-day (norethindrone and ethinyl estradiol) Tab- Do. lets USP, 1 mg/0.035 mg. ANDA 071545 .... Norcept-E 1/35 21-day (norethindrone and ethinyl estradiol) Janssen Pharmaceuticals, Inc., 1000 U.S. Highway 202, P.O. Tablets USP, 1 mg/0.035 mg. Box 300, Raritan, NJ 08869–0602. ANDA 071546 .... Norcept-E 1/35 28-day (norethindrone and ethinyl estradiol) Do. Tablets USP, 1 mg/0.035 mg. ANDA 071690 .... Metoprolol Tartrate Tablets USP, 50 mg ................................. Watson Laboratories, Inc., Subsidiary of Teva Pharma- ceuticals USA, Inc. ANDA 071691 .... Metoprolol Tartrate Tablets USP, 100 mg ............................... Do. ANDA 074633 .... Atracurium Besylate Injection, 10 mg/mL (Single-dose Vials) Hospira, Inc. ANDA 074639 .... Atracurium Besylate Injection, 10 mg/mL (Abboject Syringe) Do. ANDA 074929 .... Etodolac Capsules USP, 300 mg ............................................ ECI Pharmaceuticals, LLC, 5311 NW 35th Terrace, Fort Lau- derdale, FL 33309. ANDA 075870 .... Famotidine Injection, 10 mg/mL ............................................... Hospira, Inc. ANDA 076058 .... Midazolam HCl Syrup, EQ 2 mg base/mL .............................. Sun Pharmaceutical Industries, Ltd., c/o Sun Pharmaceutical Industries, Inc., 2 Independence Way, Princeton, NJ 08540. ANDA 083140 .... Hydrocortisone Tablets, 20 mg ................................................ Nexgen Pharma, Inc., 46 Corporate Park, Suite 200, Irvine, CA 92606. ANDA 083633 .... Isoniazid Tablets, 300 mg ........................................................ Sun Pharmaceutical Industries, Inc. ANDA 083634 .... Diphenhydramine HCl Capsules, 25 mg ................................. Nexgen Pharma, Inc. ANDA 084050 .... Isoniazid Tablets, 100 mg ........................................................ Do. ANDA 084220 .... Meprobamate Tablets, 200 mg ................................................ Do. ANDA 084238 .... Pentobarbital Sodium Tablets, 100 mg ................................... Do. ANDA 084487 .... Phentermine HCl Capsules USP, 30 mg ................................. Upsher-Smith Laboratories, LLC, 301 South Cherokee St., Denver, CO 80223. ANDA 084589 .... Meprobamate Tablets, 400 mg ................................................ Nexgen Pharma, Inc. ANDA 084915 .... Folic Acid Tablets, 1 mg .......................................................... Do. ANDA 085499 .... Potassium Chloride for Injection Concentrate USP, 2 milli- Baxter Healthcare Corp., 1620 Waukegan Rd., McGaw Park, equivalents/mL. IL 60085. daltland on DSKBBV9HB2PROD with NOTICES ANDA 085985 .... Dimenhydrinate Tablets, 50 mg ............................................... Nexgen Pharma, Inc. ANDA 086020 .... Phendimetrazine Tartrate Tablets, 35 mg ............................... Do. ANDA 086187 .... Brompheniramine Maleate Tablets, 4 mg ................................ Do. ANDA 086392 .... Meclizine HCl Tablets, 25 mg (Chewable) .............................. Do. ANDA 086835 .... Polaramine (dexchlorpheniramine maleate) Tablets, 2 mg ..... Merck Sharp & Dohme Corp., Subsidiary of Merck & Co., Inc. ANDA 086837 .... Polaramine (dexchlorpheniramine maleate) Syrup, 2 mg/5 Do. mL. VerDate Sep<11>2014 20:10 Feb 21, 2018 Jkt 244001 PO 00000 Frm 00086 Fmt 4703 Sfmt 4703 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 ....................... Alpharma US Pharms., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. ANDA 087858 .... Isoetharine Mesylate Metered Dose Inhaler, 0.34 mg/inhala- Do. tion. ANDA 088430 .... Phentermine HCl Capsules USP, 30 mg ................................. Upsher-Smith Laboratories, LLC. ANDA 089381 .... Hydroxyzine HCl Tablets USP, 10 mg .................................... Sun Pharmaceutical Industries, Inc. ANDA 089382 .... Hydroxyzine HCl Tablets USP, 25 mg .................................... Do. ANDA 089383 .... Hydroxyzine HCl Tablets USP, 50 mg .................................... Do. ANDA 089481 .... Acetaminophen and Codeine Phosphate Tablets USP, 300 American Therapeutics, Inc., 89 Carlough Rd., Bohemia, NY mg/15 mg. 11716. ANDA 089482 .... Acetaminophen and Codeine Phosphate Tablets USP, 300 Do. mg/30 mg. ANDA 089489 .... Diphenhydramine HCl Capsules, 50 mg ................................. Sun Pharmaceutical Industries, Inc. ANDA 091258 .... Furosemide Tablets USP, 20 mg, 40 mg, and 80 mg ............ Do. NDA 208056 ...... Dexilant Solutab (dexlansoprazole) Delayed-Release Orally Takeda Pharmaceuticals U.S.A., Inc., One Takeda Pkwy., Disintegrating Tablets, 30 mg. Deerfield, IL 60015. Therefore, approval of the proposed collection of information, identifies you in the body of your applications listed in the table, and all including each proposed extension of an comments, that information will be amendments and supplements thereto, existing collection of information, and posted on https://www.regulations.gov. is hereby withdrawn as of March 26, to allow 60 days for public comment in • If you want to submit a comment 2018. Introduction or delivery for response to the notice. This notice with confidential information that you introduction into interstate commerce of solicits comments on information do not wish to be made available to the products without approved new drug collection related to Medical Device public, submit the comment as a applications violates section 301(a) and Recall Authority. written/paper submission and in the (d) of the Federal Food, Drug, and DATES: Submit either electronic or manner detailed (see ‘‘Written/Paper Cosmetic Act (21 U.S.C. 331(a) and (d)). written comments on the collection of Submissions’’ and ‘‘Instructions’’). Drug products that are listed in the table information by April 23, 2018. Written/Paper Submissions that are in inventory on March 26, 2018 ADDRESSES: You may submit comments may continue to be dispensed until the as follows. Please note that late, Submit written/paper submissions as inventories have been depleted or the untimely filed comments will not be follows: drug products have reached their considered. Electronic comments must • Mail/Hand delivery/Courier (for expiration dates or otherwise become be submitted on or before April 23, written/paper submissions): Dockets violative, whichever occurs first. 2018. The https://www.regulations.gov Management Staff (HFA–305), Food and electronic filing system will accept Drug Administration, 5630 Fishers Dated: February 15, 2018. comments until midnight Eastern Time Lane, Rm. 1061, Rockville, MD 20852. Leslie Kux, • For written/paper comments Associate Commissioner for Policy. at the end of April 23, 2018. Comments received by mail/hand delivery/courier submitted to the Dockets Management [FR Doc. 2018–03607 Filed 2–21–18; 8:45 am] Staff, FDA will post your comment, as (for written/paper submissions) will be BILLING CODE 4164–01–P considered timely if they are well as any attachments, except for postmarked or the delivery service information submitted, marked and acceptance receipt is on or before that identified, as confidential, if submitted DEPARTMENT OF HEALTH AND as detailed in ‘‘Instructions.’’ HUMAN SERVICES date. Instructions: All submissions received Electronic Submissions must include the Docket No. FDA– Food and Drug Administration Submit electronic comments in the 2018–N–0405 for ‘‘Medical Device [Docket No. FDA–2018–N–0405] following way: Recall Authority.’’ Received comments, • Federal eRulemaking Portal: those filed in a timely manner (see Agency Information Collection https://www.regulations.gov. Follow the ADDRESSES), will be placed in the docket Activities; Proposed Collection; instructions for submitting comments. and, except for those submitted as Comment Request; Medical Device Comments submitted electronically, ‘‘Confidential Submissions,’’ publicly Recall Authority including attachments, to https:// viewable at https://www.regulations.gov AGENCY: Food and Drug Administration, www.regulations.gov will be posted to or at the Dockets Management Staff HHS. the docket unchanged. Because your between 9 a.m. and 4 p.m., Monday ACTION: Notice. comment will be made public, you are through Friday. solely responsible for ensuring that your • Confidential Submissions—To SUMMARY: The Food and Drug comment does not include any submit a comment with confidential Administration (FDA or Agency) is confidential information that you or a information that you do not wish to be daltland on DSKBBV9HB2PROD with NOTICES announcing an opportunity for public third party may not wish to be posted, made publicly available, submit your comment on the proposed collection of such as medical information, your or comments only as a written/paper certain information by the Agency. anyone else’s Social Security number, or submission. You should submit two Under the Paperwork Reduction Act of confidential business information, such copies total. One copy will include the 1995 (PRA), Federal Agencies are as a manufacturing process. Please note information you claim to be confidential required to publish notice in the that if you include your name, contact with a heading or cover note that states Federal Register concerning each information, or other information that ‘‘THIS DOCUMENT CONTAINS VerDate Sep<11>2014 20:10 Feb 21, 2018 Jkt 244001 PO 00000 Frm 00087 Fmt 4703 Sfmt 4703 E:\FR\FM\22FEN1.SGM 22FEN1


Document Created: 2018-02-22 02:50:58
Document Modified: 2018-02-22 02:50:58
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesApproval is withdrawn as of March 26, 2018.
ContactFlorine 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.
FR Citation83 FR 7738 
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