新兽药及新兽药申请的批准;赞助商的变更;新兽药申请批准的撤销(New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor; Withdrawal of Approval of New Animal Drug Applications)

　　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

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　　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

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　　Table 1—Original and Supplemental NADAs and ANADAs Approved During September and October 2014

　　DATES:

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　　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:

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　　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.

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