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Lee-sogaard boehringer-ingelheim.com From CappelLynch Callie mailto Callie. CappelLynch fda.hhs. gov To Lee-Sogaard Dr. Lee-sogaard boehringer-ingelheim.com RE NDA 206073 empagliflozin linagliptin FDC Tuesday January 27 2015 4 46 00 PM image001. May be a refuse-to-file RTF issue. Based on current submission timelines the empagliflozin linagliptin FDC NDA will be FDA review period for empagliflozin linagliptin FDC NDA based on PDUFA V guidelines will be 10 months following submission. The...
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Suppl na is a supplementary document that provides additional information or clarifications for a primary document.
Individuals or entities who need to provide extra details or corrections related to a previously submitted document may be required to file a suppl na.
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The purpose of suppl na is to ensure that all relevant information is accurately provided and to address any discrepancies or missing details in the primary document.
The information that must be reported on a suppl na may vary depending on the nature of the primary document or the specific requirements of the requesting party.
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