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FDA Drug Application 022505 by THERATECHNOLOGIES

Application Number022505
Application Type New Drug Application
Sponsor ApplicantTHERATECHNOLOGIES
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/10/2010N26949000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022505s000lbl.pdf 11/12/2010
AP011/10/2010N26957000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022505s000ltr.pdf 11/15/2010
AP011/10/2010N27277000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022505Orig1s000TOC.cfm 12/14/2010
AP011/10/2010N27278000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022505Orig1s000SumR.pdf 12/14/2010
AP011/29/2011SCM30873001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022505s001s003lbl.pdf 12/2/2011
AP011/29/2011SLR30874003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022505s001s003lbl.pdf 12/2/2011
AP01/7/2013SCM34876004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022505s004lbl.pdf 1/11/2013
AP012/15/2014SCM       
AP02/9/2015SCM       
AP06/8/2015SLR43028007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022505s007lbl.pdf 6/10/2015
AP06/8/2015SLR43029007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022505Orig1s007ltr.pdf 6/10/2015




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