Rules and Regulations. Notification of withdrawal

Agency: Food and Drug Administration, HHS
Action: Notification of withdrawal
Citation: FR Doc. 2020-06689 · Docket No. FDA-2019-N-0002 · 21 CFR 520, 522, 526

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

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 (ampicillin trihydrate) Capsules 520.90c. 055-050 PRINCILLIN (ampicillin trihydrate) Soluble Powder 520.90e. 055-056 PRINCILLIN (ampicillin trihydrate) Bolus 520.90f. 055-061 PRINCILLIN “125” For Oral Suspension 520.90d. 055-068 BOVICLOX (cloxacillin benzathine) 526.464b. 065-013 Dihydrostreptomycin (dihydrostreptomycin sulfate) 522.650. 065-493 JETPEN (penicillin G benzathine and penicillin G procaine) Aqueous Suspension 522.1696a. 065-500 TANDEM 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055-050, 055-056, 055-061, 055-068, 065-013, 065-493, and 065-500, and all supplements and amendments thereto, is withdrawn, effective March 30, 2020.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. Dated: March 25, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020-06689 Filed 3-30-20; 8:45 am]