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Court Suspends Approval of Enroflox 100 for Cattle

Posted Apr 16 2013 8:14am

April 16, 2013

On April 12, 2013, the United States District Court for the District of Columbia issued a temporary restraining order in Civil Action No. 13-487, suspending approval of Norbrook Inc.’s Abbreviated New Animal Drug Application No. 200-495 for Enroflox 100 for treating cattle, suspending approval of the label for Enroflox 100 for treating cattle, and directing the Food and Drug Administration to notify all interested parties of this suspension until this matter is resolved.


Contact FDA

240-276-9115 FAX
Issued by: FDA, Center for Veterinary Medicine

Communications Staff, HFV-12

7519 Standish Place

Rockville, MD 20855
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