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Home » 2020 Issues » 85 FR (01/24/2020) » 2020-00422. New Animal Drugs; Withdrawal of Approval of a New Animal Drug Application; Withdrawal of Approval of Abbreviated New Animal Drug Applications

  2020-00422. New Animal Drugs; Withdrawal of Approval of a New Animal Drug Application; Withdrawal of Approval of Abbreviated New Animal Drug Applications  

  • Start Preamble

    AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notification of withdrawal.

    Start Printed Page 4211

    SUMMARY:

    The Food and Drug Administration (FDA) is withdrawing approval of a new animal drug application (NADA) and two abbreviated new animal drug applications (ANADAs) at the sponsors' request because the products are no longer manufactured or marketed.

    DATES:

    Withdrawal of approval is applicable February 3, 2020.

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    FOR FURTHER INFORMATION CONTACT:

    Sujaya Dessai, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5761, sujaya.dessai@fda.hhs.gov.

    End Further Info End Preamble Start Supplemental Information

    SUPPLEMENTARY INFORMATION:

    Fleming Laboratories, Inc., P.O. Box 34384, Charlotte, NC 28234, has requested that FDA withdraw approval of NADA 010-005 for use of WAZINE (dipiperazine sulfate and piperazine hydrochloride) Soluble Powders because the product is no longer manufactured or marketed.

    Also, Halocarbon Products Corp., 6525 The Corners Pkwy., Suite 200, Peachtree Corners, GA 30092, has requested that FDA withdraw approval of ANADA 200-200 for use of Halothane USP (halothane) because the product is no longer manufactured or marketed.

    Lastly, Mylan Institutional LLC, 4901 Hiawatha Dr., Rockford, IL 61103, has requested that FDA withdraw approval of ANADA 200-472 for use of Fomepizole Injection because the product is no longer manufactured or marketed.

    Therefore, under authority delegated to the Commissioner of Food and Drugs and in accordance with § 514.116 Notice of withdrawal of approval of application (21 CFR 514.116), notice is given that approval of NADA 010-005 and ANADAs 200-200 and 200-472, and all supplements and amendments thereto, is hereby withdrawn, effective February 3, 2020.

    Elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to reflect the voluntary withdrawal of approval of these applications.

    Start Signature

    Dated: January 9, 2020.

    Lowell J. Schiller,

    Principal Associate Commissioner for Policy.

    End Signature End Supplemental Information

    [FR Doc. 2020-00422 Filed 1-23-20; 8:45 am]

    BILLING CODE 4164-01-P

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Document Information

Published:
01/24/2020
Department:
Food and Drug Administration
Entry Type:
Rule
Action:
Notification of withdrawal.
Document Number:
2020-00422
Dates:
Withdrawal of approval is applicable February 3, 2020.
Pages:
4210-4211 (2 pages)
Docket Numbers:
Docket No. FDA-2019-N-0002
PDF File:
2020-00422.pdf
Supporting Documents:
» FOI Summary oA 200-651, approved September 20, 2019 Re New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsor; Change of Sponsor’s Address
» FOI Summary oA 200-650, approved September 20, 2019 Re New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsor; Change of Sponsor’s Address
» FOI Summary oA 200-649, approved September 20, 2019 Re New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsor; Change of Sponsor’s Address
» FOI Summary oA 200-648, approved September 20, 2019 Re New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsor; Change of Sponsor’s Address
» FOI Summary oA 200-647, approved September 20, 2019 Re New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsor; Change of Sponsor’s Address
» FOI Summary oA 200-646, approved September 20, 2019 Re New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsor; Change of Sponsor’s Address
» FOI Summary oA 200-645, approved September 20, 2019 Re New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsor; Change of Sponsor’s Address
» FOI Summary oA 200-644, approved September 20, 2019 Re New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsor; Change of Sponsor’s Address
» FOI Summary oA 200-643, approved September 20, 2019 Re New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsor; Change of Sponsor’s Address
» FOI Summary oA 200-642, approved September 20, 2019 Re New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsor; Change of Sponsor’s Address
CFR: (3)
21 CFR 520
21 CFR 522
21 CFR 529