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  1. Development & Approval Process

Public Master Files (PMFs) in Development to Support Applications for Major Use and Major Species Drugs

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The information in the following table represents publically available information to support approval of new animal drug applications (NADAs).

Note: While information in a PMF is generally expected to support or complete portions of an NADA, completeness will be determined when a sponsor references the PMF for CVM review under their Investigational New Animal Drug (INAD) file or NADA. The completeness of the information may also be affected by advancing scientific knowledge, changing requirements, or significant passages of time.

PMF # Drug Indication and Species Target Animal Safety Effectiveness Human Food Safety Environmental Impact
006-074 Potassium Bromide (KBr) Control of seizures associated with idiopathic epilepsy in dogs Article
Safety References
 		   N/A  

 

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