Back to FDA Applications sponsored by JANSSEN PHARMS

FDA Drug Application 021001 by JANSSEN PHARMS

Application Number021001
Application Type New Drug Application
Sponsor ApplicantJANSSEN PHARMS
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
AP05/7/2001N4606000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21001_Axert_Approv.pdf 5/7/2001
AP05/7/2001N4607000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21001_Axert_prntlbl.pdf 5/7/2001
AP05/7/2001N7094000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101549.htm 12/8/2003
AP05/7/2001N8352000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21001_Axert.cfm 4/15/2004
AP06/1/2004SLR9088002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21001slr002ltr.pdf 6/7/2004
AP03/27/2009SLR22143008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021001s008,s009ltr.pdf 4/1/2009
AP03/27/2009SLR22176008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021001s008s009lbl.pdf 4/3/2009
AP03/27/2009SLR22144009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021001s008,s009ltr.pdf 4/1/2009
AP03/27/2009SLR22177009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021001s008s009lbl.pdf 4/3/2009
AP04/30/2009SLR22444010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021001s010,s011ltr.pdf 5/6/2009
AP04/30/2009SLR22487010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021001s010s011lbl.pdf 5/11/2009
AP04/30/2009SE522488011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021001s010s011lbl.pdf 5/11/2009
AP08/7/2014SLR40188014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021001s014lbl.pdf 8/8/2014
AP08/7/2014SLR40194014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021001Orig1s014ltr.pdf 8/11/2014




Back to FDA Applications sponsored by JANSSEN PHARMS