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FDA Drug Application 021238 by ROCHE

Application Number021238
Application Type New Drug Application
Sponsor ApplicantROCHE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 

Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/27/2001N1999000 6/27/2001
AP06/27/2001N2000000 6/27/2001
AP06/27/2001N2001000 6/27/2001
AP011/23/2005SLR13139005,021238s005lbl.pdf 11/30/2005
AP011/23/2005SLR13154005,021238s005ltr.pdf 11/30/2005
AP010/7/2009SLR23591007,020305s014,021238s007lbl.pdf 10/14/2009
AP010/7/2009SLR23851007,020305s014,021238s007ltr.pdf 11/12/2009

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