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FDA Drug Application 022474 by LAB HRA PHARMA

Application Number022474
Application Type New Drug Application
Sponsor ApplicantLAB HRA PHARMA
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
AP08/13/2010N26205000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022474s000lbl.pdf 8/13/2010
AP08/13/2010N26206000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022474s000ltr.pdf 8/13/2010
AP08/13/2010N26496000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022474s000TOC.cfm 9/17/2010
AP08/13/2010N26497000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022474s000SumR.pdf 9/17/2010
AP05/2/2012SLR32613002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022474s002ltr.pdf 5/4/2012
AP05/2/2012SLR32626002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022474s002lbl.pdf 5/7/2012
AP06/27/2014SCM       
AP06/12/2014SLR39545004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022474Orig1s004ltr.pdf 6/17/2014
AP06/12/2014SLR39569004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022474s004lbl.pdf 6/17/2014
AP08/28/2014SLR40327005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022474s005lbledt.pdf 8/28/2014
AP08/28/2014SLR40358005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022474Orig1s005ltr.pdf 9/3/2014
AP04/7/2015SCM       
AP03/10/2015SLR42102007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022474Orig1s007ltr.pdf 3/11/2015
AP03/10/2015SLR42121007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022474s007lbl.pdf 3/12/2015
AP03/10/2015SLR42329007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/022474Orig1s007TOC.cfm 3/31/2015




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