Document ID: FDA-2019-N-0002-0031
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications
Posted Date: 2020-04-01T04:00Z

[Federal Register Volume 85, Number 63 (Wednesday, April 1, 2020)]
[Rules and Regulations]
[Pages 18125-18126]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-06689]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520, 522, and 526

[Docket No. FDA-2019-N-0002]

New Animal Drugs; Withdrawal of Approval of New Animal Drug 
Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of withdrawal.

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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

FOR FURTHER INFORMATION CONTACT: Sujaya Dessai, Center for Veterinary 
Medicine (HFV-212), Food and Drug

[[Page 18126]]

Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5761, 
sujaya.dessai@fda.hhs.gov.

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 name        21 CFR  section
------------------------------------------------------------------------
055-036......................  PRINCILLIN             520.90c.
                                (ampicillin
                                trihydrate) Capsules.
055-050......................  PRINCILLIN             520.90e.
                                (ampicillin
                                trihydrate) Soluble
                                Powder.
055-056......................  PRINCILLIN             520.90f.
                                (ampicillin
                                trihydrate) Bolus.
055-061......................  PRINCILLIN ``125''     520.90d.
                                For Oral Suspension.
055-068......................  BOVICLOX (cloxacillin  526.464b.
                                benzathine).
065-013......................  Dihydrostreptomycin    522.650.
                                (dihydrostreptomycin
                                sulfate).
065-493......................  JETPEN (penicillin G   522.1696a.
                                benzathine and
                                penicillin G
                                procaine) Aqueous
                                Suspension.
065-500......................  TANDEM PEN             522.1696b.
                                (penicillin G
                                procaine).
------------------------------------------------------------------------

    Therefore, under authority delegated to the Commissioner of Food 
and Drugs and in accordance with Sec.  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.

    Dated: March 25, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-06689 Filed 3-30-20; 8:45 am]
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