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FDA Drug Application 021648 by ROXANE

Application Number021648
Application Type New Drug Application
Sponsor ApplicantROXANE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type Drug already marketed, but without an approved NDA
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/26/2004N10096000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21648ltr.pdf 8/31/2004
AP08/26/2004N10097000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21648lbl.pdf 8/31/2004
AP08/26/2004N16703000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021648s000TOC.cfm 6/4/2007
AP09/26/2011SLR30087004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021648s004lbl.pdf 9/27/2011
AP09/26/2011SLR30185004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021648s004ltr.pdf 10/3/2011
AP09/26/2011SLR30471004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021648Orig1REVs004.pdf 11/2/2011
AP011/18/2011SLR30725005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021648s005ltr.pdf 11/22/2011
AP011/18/2011SLR30859005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021648s005lbl.pdf 12/2/2011
AP09/27/2012SLR33868006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021648s006lbl.pdf 9/28/2012
AP09/27/2012SLR33911006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021648Orig1s006ltr.pdf 10/2/2012
AP07/3/2014SCM       
AP07/28/2015SLR43514008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021648Orig1s008ltr.pdf 7/29/2015
AP07/28/2015SLR43541008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021648s008lbl.pdf 7/30/2015




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