
Get the free SUPPLEMENTAL ABBREVIATED NEW ANIMAL DRUG APPLICATION
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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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What is supplemental abbreviated new animal?
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.
Who is required to file supplemental abbreviated new animal?
Manufacturers or sponsors of animal drugs are required to file supplemental abbreviated new animal applications.
How to fill out supplemental abbreviated new animal?
Supplemental abbreviated new animal applications can be filled out online through the FDA's electronic submission portal.
What is the purpose of supplemental abbreviated new animal?
The purpose of supplemental abbreviated new animal is to expand the approved animal species for use of an existing animal drug.
What information must be reported on supplemental abbreviated new animal?
Supplemental abbreviated new animal must include information on the new animal species, proposed labeling, safety and efficacy data.
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