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Home » 2020 Issues » 85 FR (04/01/2020) » 2020-06689. New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications

  2020-06689. New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications  

  • Start Preamble

    AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notification of withdrawal.

    SUMMARY:

    The Food and Drug Administration (FDA) is withdrawing approval of eight new animal drug applications (NADAs) at the sponsor's request because the products are no longer manufactured or marketed.

    DATES:

    Withdrawal of approval is effective March 30, 2020

    Start Further Info

    FOR FURTHER INFORMATION CONTACT:

    Sujaya Dessai, Center for Veterinary Medicine (HFV-212), Food and Drug Start Printed Page 18126Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5761, sujaya.dessai@fda.hhs.gov.

    End Further Info End Preamble Start Supplemental Information

    SUPPLEMENTARY INFORMATION:

    Norbrook Laboratories, Ltd., Station Works, Newry BT35 6JP, Northern Ireland, has requested that FDA withdraw approval of the NADAs listed in the following table because the products are no longer manufactured or marketed:

    File No.Product name21 CFR section
    055-036PRINCILLIN (ampicillin trihydrate) Capsules520.90c.
    055-050PRINCILLIN (ampicillin trihydrate) Soluble Powder520.90e.
    055-056PRINCILLIN (ampicillin trihydrate) Bolus520.90f.
    055-061PRINCILLIN “125” For Oral Suspension520.90d.
    055-068BOVICLOX (cloxacillin benzathine)526.464b.
    065-013Dihydrostreptomycin (dihydrostreptomycin sulfate)522.650.
    065-493JETPEN (penicillin G benzathine and penicillin G procaine) Aqueous Suspension522.1696a.
    065-500TANDEM PEN (penicillin G procaine)522.1696b.

    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 NADAs 055-036, 055-050, 055-056, 055-061, 055-068, 065-013, 065-493, and 065-500, and all supplements and amendments thereto, is withdrawn, effective March 30, 2020.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: March 25, 2020.

    Lowell J. Schiller,

    Principal Associate Commissioner for Policy.

    End Signature End Supplemental Information

    [FR Doc. 2020-06689 Filed 3-30-20; 8:45 am]

    BILLING CODE 4164-01-P

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Document Information

Effective Date:
3/30/2020
Published:
04/01/2020
Department:
Food and Drug Administration
Entry Type:
Rule
Action:
Notification of withdrawal.
Document Number:
2020-06689
Dates:
Withdrawal of approval is effective March 30, 2020
Pages:
18125-18126 (2 pages)
Docket Numbers:
Docket No. FDA-2019-N-0002
PDF File:
2020-06689.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 526