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Date of Approval: July 28, 2015FREEDOM OF INFORMATION SUMMARY SUPPLEMENTAL ABBREVIATED NEW ANIMAL DRUG APPLICATIONANADA 200495 ENROLLED 100 Ciprofloxacin injectable solution Beef and nonlactating
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Supplemental abbreviated new animal is an application submitted to the FDA to request approval for adding a new animal species to an existing animal drug approval.
Manufacturers or sponsors of animal drugs are required to file supplemental abbreviated new animal applications.
Supplemental abbreviated new animal applications can be filled out online through the FDA's electronic submission portal.
The purpose of supplemental abbreviated new animal is to expand the approved animal species for use of an existing animal drug.
Supplemental abbreviated new animal must include information on the new animal species, proposed labeling, safety and efficacy data.
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