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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   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21238ltr.pdf 6/27/2001
AP06/27/2001N2000000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21238lbl.pdf 6/27/2001
AP06/27/2001N2001000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-238_Kytril.cfm 6/27/2001
AP011/5/2002SCM       
AP011/25/2002SCS       
AP011/23/2005SLR13139005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020305s010,021238s005lbl.pdf 11/30/2005
AP011/23/2005SLR13154005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020305s010,021238s005ltr.pdf 11/30/2005
AP010/7/2009SLR23591007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020239s021,020305s014,021238s007lbl.pdf 10/14/2009
AP010/7/2009SLR23851007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020239s021,020305s014,021238s007ltr.pdf 11/12/2009




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