Determination That CORTONE (Cortisone Acetate) Tablets and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 43388-43390 [2017-19611]

Download as PDF 43388 Federal Register / Vol. 82, No. 178 / Friday, September 15, 2017 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–3137] Advisory Committee; Nonprescription Drugs Advisory Committee, Renewal AGENCY: Food and Drug Administration, HHS. Notice; renewal of advisory committee. ACTION: The Food and Drug Administration (FDA) is announcing the renewal of the Nonprescription Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Nonprescription Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until August 27, 2019. DATES: Authority for the Nonprescription Drugs Advisory Committee will expire on August 27, 2017, unless the Commissioner formally determines that renewal is in the public interest. FOR FURTHER INFORMATION CONTACT: Moon Hee 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, email: NDAC@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102–3.65 and approval by the Department of Health and Human Services pursuant to 45 CFR part 11 and by the General Services Administration, FDA is announcing the renewal of the Nonprescription Drugs Advisory Committee (Committee). The Committee is a discretionary Federal advisory committee established to provide advice to the Commissioner. The Committee advises the Commissioner or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs for human use and, as required, any other product for which FDA has regulatory responsibility. The Committee reviews and evaluates data concerning the safety and effectiveness of over-the-counter (nonprescription) human drug products, or any other FDA-regulated product, for use in the treatment of a broad spectrum of human symptoms and diseases and advises the Commissioner either on the issuance of monographs establishing conditions under which these drugs are generally recognized as safe and effective and not misbranded or on the mstockstill on DSK30JT082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:07 Sep 14, 2017 Jkt 241001 approval of new drug applications for such drugs. The Committee serves as a forum for the exchange of views regarding the prescription and nonprescription status, including switches from one status to another, of these various drug products and combinations thereof. The Committee may also conduct peer review of Agency sponsored intramural and extramural scientific biomedical programs in support of FDA’s mission and regulatory responsibilities. The Committee shall consist of a core of 10 voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of internal medicine, family practice, clinical toxicology, clinical pharmacology, pharmacy, dentistry, and related specialties. Members will be invited to serve for overlapping terms of up to 4 years. Almost all non-Federal members of this committee serve as Special Government Employees. The core of voting members may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests and is recommended by either a consortium of consumer-oriented organizations or other interested persons. In addition to the voting members, the Committee may include one non-voting member who is identified with industry interests. Further information regarding the most recent charter and other information can be found at https:// www.fda.gov/AdvisoryCommittees/ CommitteesMeetingMaterials/ Drugs/Nonprescription DrugsAdvisoryCommittee/default.htm or by contacting the Designated Federal Officer (see FOR FURTHER INFORMATION CONTACT). In light of the fact that no change has been made to the committee name or description of duties, no amendment will be made to 21 CFR 14.100. This document is issued under the Federal Advisory Committee Act (5 U.S.C. app.). For general information related to FDA advisory committees, please visit us at https://www.fda.gov/ AdvisoryCommittees/default.htm. Dated: September 11, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–19670 Filed 9–14–17; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–N–4758] Determination That CORTONE (Cortisone Acetate) Tablets and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements. SUMMARY: FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 20993–0002, 301–796–8363, Stacy.Kane@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98–417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products approved under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the ‘‘listed drug,’’ which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the ‘‘Approved Drug Products With Therapeutic Equivalence Evaluations,’’ which is generally known as the ‘‘Orange Book.’’ Under FDA regulations, a drug is removed from the list if the Agency withdraws or suspends E:\FR\FM\15SEN1.SGM 15SEN1 43389 Federal Register / Vol. 82, No. 178 / Friday, September 15, 2017 / Notices approval of the drug’s NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). Under § 314.161(a) (21 CFR 314.161(a)), the Agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness: (1) Before an ANDA that refers to that listed drug may be approved, (2) whenever a listed drug is voluntarily withdrawn from sale and ANDAs that refer to the listed drug have been approved, and (3) when a person petitions for such a determination under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if FDA determines that a listed drug was withdrawn from sale for safety or effectiveness reasons, the Agency will initiate proceedings that could result in the withdrawal of approval of the ANDAs that refer to the listed drug. FDA has become aware that the drug products listed in the table are no longer being marketed. Application No. Drug name Active ingredient(s) Strength(s) Dosage form/route NDA 007750 .......... NDA 008662 .......... NDA 010571 .......... CORTONE ........................... NYDRAZID ........................... COMPAZINE ........................ Cortisone Acetate ....... Isoniazid ...................... Prochlorperazine Maleate. Tablet; Oral ................. Injectable; Injection ..... Tablet; Oral ................. NDA 010670 .......... NDA 011127 .......... ORINASE ............................. COMPAZINE ........................ Tolbutamide ................ Prochlorperazine ......... 25 milligrams (mg) ............... 100 mg/milliliter (mL) ............ Equivalent to (EQ) 5 mg Base; EQ 10 mg Base; EQ 25 mg Base. 250 mg; 500 mg ................... 2.5 mg; 5 mg; 25 mg ........... NDA 011808 .......... MELLARIL ............................ 30 mg/mL; 100 mg/mL ......... Concentrate; Oral ....... NDA 012145 .......... PROLIXIN ............................. Thioridazine Hydrochloride (HCl). Fluphenazine HCl ....... 2.5 mg/5 mL ......................... Elixir; Oral ................... NDA 014713 .......... Perphenazine; Amitriptyline HCl. 2 mg/10 mg; 2 mg/25 mg; 4 mg/10 mg; 4 mg/25 mg. Tablet; Oral ................. Perphenazine; Amitriptyline HCl. 2 mg/10 mg; 2 mg/25 mg; 4 mg/10 mg; 4 mg/25 mg; 4 mg/50 mg. Tablet; Oral ................. New River Pharmaceuticals Inc. NDA 015539 .......... ETRAFON 2–10; ETRAFON 2–25; ETRAFON–A; ETRAFON–FORTE. TRIAVIL 2–10; TRIAVIL 2– 25; TRIAVIL 4–10; TRIAVIL 4–25; TRIAVIL 4–50. SERAX ................................. Oxazepam ................... NDA 015922 .......... HALDOL ............................... Haloperidol Lactate ..... 10 mg; 15 mg; 30 mg; 15 mg. EQ 2 mg Base/mL ............... Capsule; Oral .............. Tablet; Oral ................. Concentrate; Oral ....... NDA 016584 .......... NAVANE ............................... Thiothixene ................. Capsule; Oral .............. NDA 016721 .......... DALMANE ............................ Flurazepam HCl .......... 1 mg; 2 mg; 5 mg; 10 mg; 20 mg. 15 mg; 30 mg ....................... Alpharma U.S. Pharmaceuticals Division. Ortho-McNeil Pharmaceutical. Pfizer Inc. NDA 017923 .......... MELLARIL–S ........................ Thioridazine ................ NDA 018374 .......... BACTRIM ............................. NDA 018485 .......... ISOPTIN ............................... Sulfamethoxazole; Trimethoprim. Verapamil HCl ............. NDA NDA NDA NDA .......... .......... .......... .......... INTAL ................................... WELLBUTRIN ...................... DIZAC ................................... ZEBETA ............................... NDA 020007 .......... NDA 014715 .......... Tablet; Oral ................. Suppository; Rectal ..... Merck & Co., Inc. Sandoz Canada Inc. SmithKline Beecham Corporation d/b/a GlaxoSmithKline. Pharmacia and Upjohn Co. SmithKline Beecham Corporation d/b/a GlaxoSmithKline. Novartis Pharmaceuticals Corp. Apothecon Inc., Division of Bristol Myers Squibb. Schering Corp. Injectable; Injection ..... 2.5 mg/mL ............................ Injectable; Injection ..... Cromolyn Sodium ....... Bupropion HCl ............ Diazepam .................... Bisoprolol Fumarate .... 10 mg/mL ............................. 50 mg; 75 mg; 100 mg ........ 5 mg/mL ............................... 5 mg; 10 mg ......................... Solution; Inhalation ..... Tablet; Oral ................. Injectable; Injection ..... Tablet; Oral ................. ZOFRAN; ZOFRAN PRESERVATIVE FREE. PSORCON ........................... Ondansetron HCl ........ EQ 2 mg Base/mL ............... Injectable; Injection ..... NDA 020205 .......... Diflorasone Diacetate 0.05% ................................... Cream; Topical ........... NDA 020947 .......... NDA 021575 .......... PENNSAID ........................... FOSAMAX ............................ Diclofenac Sodium ...... Alendronate Sodium ... 1.5% ..................................... EQ 70 mg Base/75 mL ........ Solution; Topical ......... Solution; Oral .............. NDA 050542 .......... AMOXIL ................................ Amoxicillin ................... 125 mg; 250 mg ................... Chewable Tablet; Oral NDA 050564 .......... AUGMENTIN ‘250’; AUGMENTIN ‘500‘. Tablet; Oral ................. EQ 20 mg Base/mL; EQ 40 mg Base/mL; EQ 20 mg Base/mL; EQ 40 mg Base/ mL. Injectable; Injection ..... Merck & Co., Inc. NDA 050591 .......... MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER; MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER. BACTROBAN ....................... Amoxicillin; Clavulanate Potassium. Cefoxitin Sodium ......... 250 mg/EQ 125 mg Base; 500 mg/EQ 125 mg Base. NDA 050581 .......... mstockstill on DSK30JT082PROD with NOTICES EQ 25 mg HCl/5 mL; EQ 100 mg HCl/5mL. 80 mg/mL; 16 mg/mL ........... Valeant Pharmaceuticals International. Novartis Pharmaceuticals Corp. Sun Pharmaceutical Industries, Inc. Mt. Adams Technologies LLC. King Pharmaceuticals LLC. GlaxoSmithKline LLC. Pharmacia and Upjohn Co. Teva Branded Pharmaceutical Products R&D, Inc. Novartis Pharmaceuticals Corp. Taro Pharmaceuticals North America Inc. Nuvo Pharmaceuticals Inc. Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Dr. Reddy’s Laboratories, Inc. Do. Mupirocin .................... 2% ........................................ Ointment; Topical ........ NDA 050594 .......... ERYCETTE .......................... Erythromycin ............... 2% ........................................ Swab; Topical ............. NDA 050754 .......... AMOXIL ................................ Amoxicillin ................... 500 mg; 875 mg ................... Tablet; Oral ................. NDA 050760 .......... AMOXIL ................................ Amoxicillin ................... 200 mg/5 mL; 400 mg/5 mL For Suspension; Oral .. SmithKline Beecham (Cork) Ltd., Ireland. Johnson & Johnson Consumer Inc. Dr. Reddy’s Laboratories, Inc. Do. 018596 018644 019287 019982 VerDate Sep<11>2014 17:07 Sep 14, 2017 Jkt 241001 PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 Capsule; Oral .............. Applicant Suspension; Oral ........ E:\FR\FM\15SEN1.SGM 15SEN1 43390 Federal Register / Vol. 82, No. 178 / Friday, September 15, 2017 / Notices FDA has reviewed its records and, under § 314.161, has determined that the drug products listed were not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list the drug products in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. The ‘‘Discontinued Drug Product List’’ identifies, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. Approved ANDAs that refer to the NDAs and ANDAs listed are unaffected by the discontinued marketing of the products subject to those NDAs and ANDAs. Additional ANDAs that refer to these products may also be approved by the Agency if they comply with relevant legal and regulatory requirements. If FDA determines that labeling for these drug products should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. Dated: September 11, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–19611 Filed 9–14–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–D–4886] Utilizing Animal Studies To Evaluate Organ Preservation Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ‘‘Utilizing Animal Studies to Evaluate Organ Preservation Devices.’’ The intent of this draft guidance is to provide recommendations regarding best practices for utilizing animal studies for the evaluation of organ preservation devices. This draft guidance is not final nor is it in effect at this time. DATES: Submit either electronic or written comments on the draft guidance by November 14, 2017 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. mstockstill on DSK30JT082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:16 Sep 14, 2017 Jkt 241001 You may submit comments on any guidance at any time as follows: ADDRESSES: 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 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– 2017–D–4886 for ‘‘Utilizing Animal Studies to Evaluate Organ Preservation Devices.’’ Received comments 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 PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). An electronic copy of the guidance document is available for download from the internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the draft guidance document entitled ‘‘Utilizing Animal Studies to Evaluate Organ Preservation Devices’’ to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993–0002. Send one selfaddressed adhesive label to assist that office in processing your request. FOR FURTHER INFORMATION CONTACT: Elizabeth Kunkoski, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1504, Silver Spring, MD 20993–0002, 301–796–6439. SUPPLEMENTARY INFORMATION: E:\FR\FM\15SEN1.SGM 15SEN1

Agencies

[Federal Register Volume 82, Number 178 (Friday, September 15, 2017)]
[Notices]
[Pages 43388-43390]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-19611]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-4758]


Determination That CORTONE (Cortisone Acetate) Tablets and Other 
Drug Products Were Not Withdrawn From Sale for Reasons of Safety or 
Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) has 
determined that the drug products listed in this document were not 
withdrawn from sale for reasons of safety or effectiveness. This 
determination means that FDA will not begin procedures to withdraw 
approval of abbreviated new drug applications (ANDAs) that refer to 
these drug products, and it will allow FDA to continue to approve ANDAs 
that refer to the products as long as they meet relevant legal and 
regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363, 
Stacy.Kane@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price 
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) 
(the 1984 amendments), which authorized the approval of duplicate 
versions of drug products approved under an ANDA procedure. ANDA 
applicants must, with certain exceptions, show that the drug for which 
they are seeking approval contains the same active ingredient in the 
same strength and dosage form as the ``listed drug,'' which is a 
version of the drug that was previously approved. ANDA applicants do 
not have to repeat the extensive clinical testing otherwise necessary 
to gain approval of a new drug application (NDA).
    The 1984 amendments include what is now section 505(j)(7) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which 
requires FDA to publish a list of all approved drugs. FDA publishes 
this list as part of the ``Approved Drug Products With Therapeutic 
Equivalence Evaluations,'' which is generally known as the ``Orange 
Book.'' Under FDA regulations, a drug is removed from the list if the 
Agency withdraws or suspends

[[Page 43389]]

approval of the drug's NDA or ANDA for reasons of safety or 
effectiveness, or if FDA determines that the listed drug was withdrawn 
from sale for reasons of safety or effectiveness (21 CFR 314.162).
    Under Sec.  314.161(a) (21 CFR 314.161(a)), the Agency must 
determine whether a listed drug was withdrawn from sale for reasons of 
safety or effectiveness: (1) Before an ANDA that refers to that listed 
drug may be approved, (2) whenever a listed drug is voluntarily 
withdrawn from sale and ANDAs that refer to the listed drug have been 
approved, and (3) when a person petitions for such a determination 
under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if 
FDA determines that a listed drug was withdrawn from sale for safety or 
effectiveness reasons, the Agency will initiate proceedings that could 
result in the withdrawal of approval of the ANDAs that refer to the 
listed drug.
    FDA has become aware that the drug products listed in the table are 
no longer being marketed.

----------------------------------------------------------------------------------------------------------------
                                               Active                           Dosage form/
    Application No.         Drug name       ingredient(s)      Strength(s)          route           Applicant
----------------------------------------------------------------------------------------------------------------
NDA 007750............  CORTONE.........  Cortisone         25 milligrams     Tablet; Oral....  Merck & Co.,
                                           Acetate.          (mg).                               Inc.
NDA 008662............  NYDRAZID........  Isoniazid.......  100 mg/           Injectable;       Sandoz Canada
                                                             milliliter (mL).  Injection.        Inc.
NDA 010571............  COMPAZINE.......  Prochlorperazine  Equivalent to     Tablet; Oral....  SmithKline
                                           Maleate.          (EQ) 5 mg Base;                     Beecham
                                                             EQ 10 mg Base;                      Corporation d/b/
                                                             EQ 25 mg Base.                      a
                                                                                                 GlaxoSmithKline
                                                                                                 .
NDA 010670............  ORINASE.........  Tolbutamide.....  250 mg; 500 mg..  Tablet; Oral....  Pharmacia and
                                                                                                 Upjohn Co.
NDA 011127............  COMPAZINE.......  Prochlorperazine  2.5 mg; 5 mg; 25  Suppository;      SmithKline
                                                             mg.               Rectal.           Beecham
                                                                                                 Corporation d/b/
                                                                                                 a
                                                                                                 GlaxoSmithKline
                                                                                                 .
NDA 011808............  MELLARIL........  Thioridazine      30 mg/mL; 100 mg/ Concentrate;      Novartis
                                           Hydrochloride     mL.               Oral.             Pharmaceuticals
                                           (HCl).                                                Corp.
NDA 012145............  PROLIXIN........  Fluphenazine HCl  2.5 mg/5 mL.....  Elixir; Oral....  Apothecon Inc.,
                                                                                                 Division of
                                                                                                 Bristol Myers
                                                                                                 Squibb.
NDA 014713............  ETRAFON 2-10;     Perphenazine;     2 mg/10 mg; 2 mg/ Tablet; Oral....  Schering Corp.
                         ETRAFON 2-25;     Amitriptyline     25 mg; 4 mg/10
                         ETRAFON-A;        HCl.              mg; 4 mg/25 mg.
                         ETRAFON-FORTE.
NDA 014715............  TRIAVIL 2-10;     Perphenazine;     2 mg/10 mg; 2 mg/ Tablet; Oral....  New River
                         TRIAVIL 2-25;     Amitriptyline     25 mg; 4 mg/10                      Pharmaceuticals
                         TRIAVIL 4-10;     HCl.              mg; 4 mg/25 mg;                     Inc.
                         TRIAVIL 4-25;                       4 mg/50 mg.
                         TRIAVIL 4-50.
NDA 015539............  SERAX...........  Oxazepam........  10 mg; 15 mg; 30  Capsule; Oral...  Alpharma U.S.
                                                             mg; 15 mg.       Tablet; Oral....   Pharmaceuticals
                                                                                                 Division.
NDA 015922............  HALDOL..........  Haloperidol       EQ 2 mg Base/mL.  Concentrate;      Ortho-McNeil
                                           Lactate.                            Oral.             Pharmaceutical.
NDA 016584............  NAVANE..........  Thiothixene.....  1 mg; 2 mg; 5     Capsule; Oral...  Pfizer Inc.
                                                             mg; 10 mg; 20
                                                             mg.
NDA 016721............  DALMANE.........  Flurazepam HCl..  15 mg; 30 mg....  Capsule; Oral...  Valeant
                                                                                                 Pharmaceuticals
                                                                                                 International.
NDA 017923............  MELLARIL-S......  Thioridazine....  EQ 25 mg HCl/5    Suspension; Oral  Novartis
                                                             mL; EQ 100 mg                       Pharmaceuticals
                                                             HCl/5mL.                            Corp.
NDA 018374............  BACTRIM.........  Sulfamethoxazole  80 mg/mL; 16 mg/  Injectable;       Sun
                                           ; Trimethoprim.   mL.               Injection.        Pharmaceutical
                                                                                                 Industries,
                                                                                                 Inc.
NDA 018485............  ISOPTIN.........  Verapamil HCl...  2.5 mg/mL.......  Injectable;       Mt. Adams
                                                                               Injection.        Technologies
                                                                                                 LLC.
NDA 018596............  INTAL...........  Cromolyn Sodium.  10 mg/mL........  Solution;         King
                                                                               Inhalation.       Pharmaceuticals
                                                                                                 LLC.
NDA 018644............  WELLBUTRIN......  Bupropion HCl...  50 mg; 75 mg;     Tablet; Oral....  GlaxoSmithKline
                                                             100 mg.                             LLC.
NDA 019287............  DIZAC...........  Diazepam........  5 mg/mL.........  Injectable;       Pharmacia and
                                                                               Injection.        Upjohn Co.
NDA 019982............  ZEBETA..........  Bisoprolol        5 mg; 10 mg.....  Tablet; Oral....  Teva Branded
                                           Fumarate.                                             Pharmaceutical
                                                                                                 Products R&D,
                                                                                                 Inc.
NDA 020007............  ZOFRAN; ZOFRAN    Ondansetron HCl.  EQ 2 mg Base/mL.  Injectable;       Novartis
                         PRESERVATIVE                                          Injection.        Pharmaceuticals
                         FREE.                                                                   Corp.
NDA 020205............  PSORCON.........  Diflorasone       0.05%...........  Cream; Topical..  Taro
                                           Diacetate.                                            Pharmaceuticals
                                                                                                 North America
                                                                                                 Inc.
NDA 020947............  PENNSAID........  Diclofenac        1.5%............  Solution;         Nuvo
                                           Sodium.                             Topical.          Pharmaceuticals
                                                                                                 Inc.
NDA 021575............  FOSAMAX.........  Alendronate       EQ 70 mg Base/75  Solution; Oral..  Merck Sharp &
                                           Sodium.           mL.                                 Dohme Corp., a
                                                                                                 subsidiary of
                                                                                                 Merck & Co.,
                                                                                                 Inc.
NDA 050542............  AMOXIL..........  Amoxicillin.....  125 mg; 250 mg..  Chewable Tablet;  Dr. Reddy's
                                                                               Oral.             Laboratories,
                                                                                                 Inc.
NDA 050564............  AUGMENTIN `250';  Amoxicillin;      250 mg/EQ 125 mg  Tablet; Oral....  Do.
                         AUGMENTIN `500`.  Clavulanate       Base; 500 mg/EQ
                                           Potassium.        125 mg Base.
NDA 050581............  MEFOXIN IN        Cefoxitin Sodium  EQ 20 mg Base/    Injectable;       Merck & Co.,
                         SODIUM CHLORIDE                     mL; EQ 40 mg      Injection.        Inc.
                         0.9% IN PLASTIC                     Base/mL; EQ 20
                         CONTAINER;                          mg Base/mL; EQ
                         MEFOXIN IN                          40 mg Base/mL.
                         DEXTROSE 5% IN
                         PLASTIC
                         CONTAINER.
NDA 050591............  BACTROBAN.......  Mupirocin.......  2%..............  Ointment;         SmithKline
                                                                               Topical.          Beecham (Cork)
                                                                                                 Ltd., Ireland.
NDA 050594............  ERYCETTE........  Erythromycin....  2%..............  Swab; Topical...  Johnson &
                                                                                                 Johnson
                                                                                                 Consumer Inc.
NDA 050754............  AMOXIL..........  Amoxicillin.....  500 mg; 875 mg..  Tablet; Oral....  Dr. Reddy's
                                                                                                 Laboratories,
                                                                                                 Inc.
NDA 050760............  AMOXIL..........  Amoxicillin.....  200 mg/5 mL; 400  For Suspension;   Do.
                                                             mg/5 mL.          Oral.
----------------------------------------------------------------------------------------------------------------


[[Page 43390]]

    FDA has reviewed its records and, under Sec.  314.161, has 
determined that the drug products listed were not withdrawn from sale 
for reasons of safety or effectiveness. Accordingly, the Agency will 
continue to list the drug products in the ``Discontinued Drug Product 
List'' section of the Orange Book. The ``Discontinued Drug Product 
List'' identifies, among other items, drug products that have been 
discontinued from marketing for reasons other than safety or 
effectiveness.
    Approved ANDAs that refer to the NDAs and ANDAs listed are 
unaffected by the discontinued marketing of the products subject to 
those NDAs and ANDAs. Additional ANDAs that refer to these products may 
also be approved by the Agency if they comply with relevant legal and 
regulatory requirements. If FDA determines that labeling for these drug 
products should be revised to meet current standards, the Agency will 
advise ANDA applicants to submit such labeling.

    Dated: September 11, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-19611 Filed 9-14-17; 8:45 am]
 BILLING CODE 4164-01-P

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