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FDA Drug Application 021088 by ORTHO MCNEIL JANSSEN

Application Number021088
Application Type New Drug Application
Sponsor ApplicantORTHO MCNEIL JANSSEN
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
AP03/3/2000N1186000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21088ltr.pdf 3/3/2000
AP03/3/2000N1187000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21088lbl.pdf 3/3/2000
AP03/3/2000N2389000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/02-1088_Vidaur.cfm 3/3/2000
AP03/3/2000N31122000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm209848.htm 12/20/2011
AP09/18/2000SCM       
AP09/28/2000SCS       
AP010/16/2000SCM       
AP01/24/2001SCM       
AP06/8/2001SCM       
AP07/5/2001SCS       
AP09/8/2005SLR12763007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021088s007ltr.pdf 9/14/2005
AP09/8/2005SLR12779007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021088s007lbl.pdf 9/14/2005
AP08/13/2001SCS       
AP08/8/2001SCM       
AP05/17/2002SCS       
AP05/23/2002SCM       
AP08/23/2002SCS       
AP05/23/2002SCS       
AP08/1/2003SLR6523015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21088slr015ltr.pdf 8/15/2003
AP010/21/2002SCS       
AP09/15/2005SLR12805022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021088s022lbl.pdf 9/22/2005
AP09/15/2005SLR12815022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021088s022ltr.pdf 9/22/2005
AP01/14/2011SLR27547025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021088s025ltr.pdf 1/20/2011
AP01/14/2011SLR27566025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021088s025lbl.pdf 1/20/2011




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