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FDA Drug Application 205433 by PULMOFLOW INC

Application Number205433
Application Type New Drug Application
Sponsor ApplicantPULMOFLOW INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
TA08/22/2014TA40322000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205433Orig1s000TAltr.pdf 8/27/2014
AP112/2/2014N40322000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205433Orig1s000TAltr.pdf 8/27/2014
TA08/22/2014TA41132000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205433Orig1s000ltr.pdf 12/3/2014
AP112/2/2014N41132000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205433Orig1s000ltr.pdf 12/3/2014
TA08/22/2014TA41133000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205433s000lbl.pdf 12/3/2014
AP112/2/2014N41133000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205433s000lbl.pdf 12/3/2014
TA08/22/2014TA42433000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205433Orig1s000TOC.cfm 4/6/2015
AP112/2/2014N42433000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205433Orig1s000TOC.cfm 4/6/2015




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