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FDA Drug Application 021615 by JANSSEN PHARMS

Application Number021615
Application Type New Drug Application
Sponsor ApplicantJANSSEN PHARMS
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
AP012/22/2004N12382000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109350.htm 7/29/2005
AP012/22/2004N13196000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021615s000_RazadyneTOC.cfm 12/5/2005
AP012/22/2004N10808000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021615s000revLTR.pdf 12/29/2004
AP012/22/2004N10831000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021615lbl.pdf 12/29/2004
AP04/27/2006SLR14019001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021169s10s12s13s14,21224s8s10s11s12,21615s1s3s4s5LTR.pdf 5/1/2006
AP05/2/2005SLR11567002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021169s011,021224s009,021615s002ltr.pdf 5/3/2005
AP04/27/2006SLR14020003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021169s10s12s13s14,21224s8s10s11s12,21615s1s3s4s5LTR.pdf 5/1/2006
AP04/27/2006SLR14021004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021169s10s12s13s14,21224s8s10s11s12,21615s1s3s4s5LTR.pdf 5/1/2006
AP04/27/2006SLR14022005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021169s10s12s13s14,21224s8s10s11s12,21615s1s3s4s5LTR.pdf 5/1/2006
AP03/1/2012SLR32022008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021169s016,021224s014,021615s008ltr.pdf 3/5/2012
AP03/1/2012SLR32045008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021169s016,021224s014,021615s008lbl.pdf 3/6/2012
AP03/1/2012SLR32050009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021169s017,021224s015,021615s009lbl.pdf 3/6/2012
AP03/1/2012SLR32019009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021224s015,021169s017,021615s009ltr.pdf 3/5/2012
AP06/28/2013SLR36433016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021169Orig1s024,021224Orig1s022,021615Orig1s016ltr.pdf 7/2/2013
AP06/28/2013SLR36530016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021169s024,021224s022,021615s016lbl.pdf 7/11/2013
AP03/1/2012SLR32579018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021169s026,021224s025,021615s018lbl.pdf 5/1/2012
AP03/1/2012SLR32009018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021169s026,021224s025,021615s018ltr.pdf 3/5/2012
AP05/21/2013SCM       
AP02/9/2015SLR41818021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021615s021lbl.pdf 2/10/2015
AP02/9/2015SLR41829021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021615Orig1s21,021169Orig1s30,021224Orig1s28ltr.pdf 2/12/2015
AP012/15/2015SLR44793022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021169Orig1s031,021224Orig1s029,021615Orig1s022ltr.pdf 12/17/2015
AP012/15/2015SLR44804022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021169s031-021224s029-021615s022lbl.pdf 12/17/2015




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