2014-07702. Zoetis Inc., et al.; Withdrawal of Approval of New Animal Drug Applications for Combination Drug Medicated Feeds Containing an Arsenical Drug; Correction  

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    AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notification of withdrawal of approval; correction.

    SUMMARY:

    The Food and Drug Administration (FDA) published a document in the Federal Register of February 27, 2014, concerning the voluntary withdrawal of approval of new animal drug applications (NADAs). The document contained an incorrect list of NADAs.

    DATES:

    This correction is effective April 7, 2014.

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    FOR FURTHER INFORMATION CONTACT:

    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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    SUPPLEMENTARY INFORMATION:

    In FR Doc. 2014-02616, appearing on page 10974 in the Federal Register of February 27, 2014, the following corrections are made:

    On page 10974, in the third column, in the 2d line of the “SUMMARY” section remove “69” and add in its place “68”.

    On page 10975, the first bulleted text “Huvepharma AD, 5th Floor, 3A Nikolay Haitov Str., 1113 Sofia, Bulgaria has requested that FDA withdraw approval of the following 16 NADAs and 8 ANADAs” is corrected to read “Huvepharma AD, 5th Floor, 3A Nikolay Haitov Str., 1113 Sofia, Bulgaria, has requested that FDA withdraw approval of the following 15 NADAs and 8 ANADAs”; and on the same page in the table, the entry “013-461 3-NITRO (roxarsone)/AMPROL Plus (amprolium and ethopabate).” is removed.

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    Dated: April 2, 2014.

    Bernadette Dunham,

    Director, Center for Veterinary Medicine.

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    [FR Doc. 2014-07702 Filed 4-4-14; 8:45 am]

    BILLING CODE 4160-01-P

Document Information

Effective Date:
4/7/2014
Published:
04/07/2014
Department:
Food and Drug Administration
Entry Type:
Rule
Action:
Notification of withdrawal of approval; correction.
Document Number:
2014-07702
Dates:
This correction is effective April 7, 2014.
Pages:
18990-18990 (1 pages)
Docket Numbers:
Docket No. FDA-2014-N-0002
PDF File:
2014-07702.pdf
Supporting Documents:
» FREEDOM OF INFORMATION SUMMARY ANADA 200-512 TRIAMULOX tiamulin hydrogen fumarate, 12.3% Liquid Concentrate Swine re New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor
» FREEDOM OF INFORMATION SUMMARY NADA 034-267 GENTOCIN DURAFILM (Gentamicin Sulfate and Betamethasone) Sterile Ophthalmic Solution re New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor
» FREEDOM OF INFORMATION SUMMARY NADA 141-349 DRAXXIN 25 Injectable Solution Tulathromycin Injection Cattle (suckling calves, dairy calves, and veal calves) re New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor
» FREEDOM OF INFORMATION SUMMARY NADA 141-276 ZILMAX plus RUMENSIN plus TYLAN (zilpaterol hydrochloride 4.8%; monensin, USP; and tylosin phosphate) Type A Medicated Articles For Use in the Manufacture of Type B and C Medicated Feeds Cattle Fed in Confinemen
» FREEDOM OF INFORMATION SUMMARY NADA 141-258 ZILMAX Zilpaterol Hydrochloride 4.8% Type A medicated article to be used in the manufacture of Type B and C medicated feeds Cattle fed in confinement for slaughter re New Animal Drugs; Approval of New Animal Dru
» FREEDOM OF INFORMATION SUMMARY NADA 141-232 SIMPLICEF Cefpodoxime proxetil Chewable tablets Dogs re New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor
» FREEDOM OF INFORMATION SUMMARY NADA 141-068 BAYTRIL 100 Injectable Solution Enrofloxacin Swine re New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor
» FREEDOM OF INFORMATION SUMMARY NADA 141-034 GAINPRO bambermycins Type A Medicated Article to be used in the manufacture of Type C Medicated Feeds Pasture cattle (slaughter, stocker, and feeder cattle, and dairy and beef replacement heifers) re New Animal
» FREEDOM OF INFORMATION SUMMARY NADA 141-437 OSURNIA florfenicol, terbinafine, betamethasone acetate Otic gel Dogs re New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor
» FREEDOM OF INFORMATION SUMMARY ANADA 200-575 Carprofen Chewable Tablets Carprofen Dogs re New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor
CFR: (2)
21 CFR 556
21 CFR 558