-
Start Preamble
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice of withdrawal of approval.
SUMMARY:
The Food and Drug Administration (FDA) is withdrawing approval of a new animal drug application (NADA). This action is being taken at the sponsors' request because this product is no longer manufactured or marketed.
DATES:
Withdrawal of approval is effective June 15, 2015.
Start Further InfoFOR FURTHER INFORMATION CONTACT:
Sujaya Dessai, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9075, sujaya.dessai@fda.hhs.gov.
End Further Info End Preamble Start Supplemental InformationSUPPLEMENTARY INFORMATION:
The Hartz Mountain Corp., 400 Plaza Dr., Secaucus, NJ 07094 has requested that FDA withdraw approval of NADA 065-222 for KEET LIFE (chlortetracycline) Bird Seed because this product is no longer manufactured or marketed.
Therefore, under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, and in accordance with 21 CFR 514.116 Notice of withdrawal of approval of application, notice is given that approval of NADA 065-222, and all supplements and amendments thereto, is hereby withdrawn, effective June 15, 2015.
The animal drug regulations are not being amended to reflect the voluntary withdrawal of approval of this application because it is not codified.
Start SignatureDated: June 1, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2015-13633 Filed 6-3-15; 8:45 am]
BILLING CODE 4164-01-P
Document Information
- Effective Date:
- 6/15/2015
- Published:
- 06/04/2015
- Department:
- Food and Drug Administration
- Entry Type:
- Notice
- Action:
- Notice of withdrawal of approval.
- Document Number:
- 2015-13633
- Dates:
- Withdrawal of approval is effective June 15, 2015.
- Pages:
- 31909-31909 (1 pages)
- Docket Numbers:
- Docket No. FDA-2015-N-0002
- PDF File:
- 2015-13633.pdf
- Supporting Documents:
- » FONSI for sN 141-361, approved December 7, 2015
- » FONSI for oN 141-453, approved December 8, 2015
- » FOI Summary for sN 141-361, approved December 7, 2015
- » FOI Summary for sN 141-258, approved December 2, 2015
- » FOI Summary for oN 141-453, approved December 8, 2015
- » EA for sN 141-361, approved December 7, 2015
- » EA for oN 141-453, approved December 8, 2015
- » Finding of No Significant Impact (FONSI) for SAFE-GUARD AQUASOL (fenbendazole oral suspension) in Chickens
- » FREEDOM OF INFORMATION SUMMARY NADA 141-442 LUTALYSE HighCon Injection Dinoprost Tromethamine Injection Lactating dairy cows, beef cows, beef heifers, and replacement dairy heifers
- » FREEDOM OF INFORMATION SUMMARY NADA 141-449 SAFE-GUARD AquaSol Fenbendazole oral suspension Broiler chickens, replacement chickens intended to become breeding chickens, and breeding chickens