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FDA Drug Application 022383 by NOVARTIS

Application Number022383
Application Type New Drug Application
Sponsor ApplicantNOVARTIS
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
AP07/1/2011N29381000 7/5/2011
AP07/1/2011N29382000 7/5/2011
AP07/1/2011N29441000 7/7/2011
AP07/1/2011N29647000REMS 8/2/2011
AP07/1/2011N29758000 8/12/2011
AP07/1/2011N29759000 8/12/2011
AP09/26/2012SLR33851002 9/26/2012
AP09/26/2012SLR33852002 9/26/2012
AP09/26/2012SLR33867002 9/27/2012
AP012/18/2012SLR34751004,s005ltr.pdf 12/26/2012
AP012/18/2012SLR34752005,s005ltr.pdf 12/26/2012

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