ACTION
Final Rule, Technical Amendment.
SUMMARY
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during September and October 2014. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship of six NADAs and four ANADAs, the voluntary withdrawal of approval of an ANADA, and a correcting amendment.
TABLE OF CONTENTS
Back to Top
DATES:
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
List of Subjects
PART 510—NEW ANIMAL DRUGS
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
TABLES
Back to Top
Table 1—Original and Supplemental NADAs and ANADAs Approved During September and October 2014
DATES:
Back to Top
This rule is effective December 15, 2014, except for the amendment to 21 CFR 520.1660d, which is effective December 26, 2014.Show citation box
FOR FURTHER INFORMATION CONTACT:
Back to Top
George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9019, george.haibel@fda.hhs.gov.
全文下载： 
Federal Register _ New Animal Drugs; Approval of New Animal Drug Application.pdf
