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

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055-050, 055-056, 055-061, 055-068, 065-013, 065-493, and 065-500, and all supplements and amendments thereto, is withdrawn, effective March 30, 2020.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

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