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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 8/31/2004
AP08/26/2004N10097000 8/31/2004
AP08/26/2004N16703000 6/4/2007
AP09/26/2011SLR30087004 9/27/2011
AP09/26/2011SLR30185004 10/3/2011
AP09/26/2011SLR30471004 11/2/2011
AP011/18/2011SLR30725005 11/22/2011
AP011/18/2011SLR30859005 12/2/2011
AP09/27/2012SLR33868006 9/28/2012
AP09/27/2012SLR33911006 10/2/2012
AP07/28/2015SLR43514008 7/29/2015
AP07/28/2015SLR43541008 7/30/2015

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