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kklar1

05/07/13 10:19 AM

#67907 RE: Aggie9518 #67906

RTF = Refusal To File

This is an FDA response to an application that does not contain the information required under FDA regulations. In the past there has been some history of companies submitting incomplete or inaccurate applications and subsequently 'repairing' it in the course of the extended review period.

Hope that helps...