85 FR 63 pgs. 18125-18126 - New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications
Type: RULEVolume: 85Number: 63Pages: 18125 - 18126
Pages: 18125, 18126Docket number: [Docket No. FDA-2019-N-0002]
FR document: [FR Doc. 2020-06689 Filed 3-30-20; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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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.
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:
[top] Sujaya Dessai, Center for Veterinary Medicine (HFV-212), Food and Drug
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055-050, 055-056, 055-061, 055-068, 065-013, 065-493, and 065-500, and all supplements and amendments thereto, is withdrawn, effective March 30, 2020.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]
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