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FDA Drug Application 021169 by JANSSEN PHARMS

Application Number021169
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
AP02/28/2001N3150000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21169ltr.pdf 2/28/2001
AP02/28/2001N3151000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21169lbl.pdf 2/28/2001
AP02/28/2001N3152000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-169_Reminyl.cfm 12/18/2001
AP02/28/2001N12380000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109350.htm 7/29/2005
AP08/15/2001SCM       
AP04/19/2002SLR3132003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21169s003.pdf 5/2/2002
AP07/31/2002SCM       
AP09/3/2003SLR6610007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21224slr005,21169slr007ltr.pdf 9/9/2003
AP04/27/2006SLR14011010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021169s10s12s13s14,21224s8s10s11s12,21615s1s3s4s5LTR.pdf 5/1/2006
AP05/2/2005SLR11565011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021169s011,021224s009,021615s002ltr.pdf 5/3/2005
AP04/27/2006SLR14012012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021169s10s12s13s14,21224s8s10s11s12,21615s1s3s4s5LTR.pdf 5/1/2006
AP04/27/2006SLR14013013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021169s10s12s13s14,21224s8s10s11s12,21615s1s3s4s5LTR.pdf 5/1/2006
AP04/27/2006SLR14014014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021169s10s12s13s14,21224s8s10s11s12,21615s1s3s4s5LTR.pdf 5/1/2006
AP03/1/2012SLR32020016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021169s016,021224s014,021615s008ltr.pdf 3/5/2012
AP03/1/2012SLR32047016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021169s016,021224s014,021615s008lbl.pdf 3/6/2012
AP03/1/2012SLR32052017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021169s017,021224s015,021615s009lbl.pdf 3/6/2012
AP03/1/2012SLR32018017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021224s015,021169s017,021615s009ltr.pdf 3/5/2012
AP06/28/2013SLR36431024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021169Orig1s024,021224Orig1s022,021615Orig1s016ltr.pdf 7/2/2013
AP06/28/2013SLR36528024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021169s024,021224s022,021615s016lbl.pdf 7/11/2013
AP03/1/2012SLR32581026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021169s026,021224s025,021615s018lbl.pdf 5/1/2012
AP03/1/2012SLR32007026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021169s026,021224s025,021615s018ltr.pdf 3/5/2012
AP05/21/2013SCM       
AP02/9/2015SLR41820030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021615s021lbl.pdf 2/10/2015
AP02/9/2015SLR41830030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021615Orig1s21,021169Orig1s30,021224Orig1s28ltr.pdf 2/12/2015
AP012/15/2015SLR44791031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021169Orig1s031,021224Orig1s029,021615Orig1s022ltr.pdf 12/17/2015
AP012/15/2015SLR44802031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021169s031-021224s029-021615s022lbl.pdf 12/17/2015




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