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FDA Drug Application 022207 by ROXANE

Application Number022207
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
AP03/17/2008N19486000, 022207s000ltr.pdf 3/19/2008
AP03/17/2008N19516000,022207lbl.pdf 3/24/2008
AP03/17/2008N22151000 4/1/2009
AP03/17/2008N22152000 4/1/2009
AP04/15/2010SLR25323002 4/21/2010
AP01/23/2012SLR31494004 1/23/2012
AP01/23/2012SLR31515004 1/25/2012

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