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FDA Drug Application 021224 by JANSSEN PHARMS

Application Number021224
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
AP06/22/2001N3147000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21224ltr.pdf 6/22/2001
AP06/22/2001N3148000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21224lbl.pdf 6/22/2001
AP06/22/2001N3149000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-224_Reminyl.cfm 3/5/2002
AP06/22/2001N12381000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109350.htm 7/29/2005
AP04/24/2002SCM       
AP04/19/2002SLR3133003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21169s003.pdf 5/2/2002
AP09/3/2003SLR6611005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21224slr005,21169slr007ltr.pdf 9/9/2003
AP04/27/2006SLR14015008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021169s10s12s13s14,21224s8s10s11s12,21615s1s3s4s5LTR.pdf 5/1/2006
AP05/2/2005SLR11566009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021169s011,021224s009,021615s002ltr.pdf 5/3/2005
AP04/27/2006SLR14016010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021169s10s12s13s14,21224s8s10s11s12,21615s1s3s4s5LTR.pdf 5/1/2006
AP04/27/2006SLR14017011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021169s10s12s13s14,21224s8s10s11s12,21615s1s3s4s5LTR.pdf 5/1/2006
AP04/27/2006SLR14018012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021169s10s12s13s14,21224s8s10s11s12,21615s1s3s4s5LTR.pdf 5/1/2006
AP03/1/2012SLR32021014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021169s016,021224s014,021615s008ltr.pdf 3/5/2012
AP03/1/2012SLR32046014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021169s016,021224s014,021615s008lbl.pdf 3/6/2012
AP03/1/2012SLR32051015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021169s017,021224s015,021615s009lbl.pdf 3/6/2012
AP03/1/2012SLR32017015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021224s015,021169s017,021615s009ltr.pdf 3/5/2012
AP06/28/2013SLR36432022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021169Orig1s024,021224Orig1s022,021615Orig1s016ltr.pdf 7/2/2013
AP06/28/2013SLR36529022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021169s024,021224s022,021615s016lbl.pdf 7/11/2013
AP03/1/2012SLR32580025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021169s026,021224s025,021615s018lbl.pdf 5/1/2012
AP03/1/2012SLR32008025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021169s026,021224s025,021615s018ltr.pdf 3/5/2012
AP05/21/2013SCM       
AP02/9/2015SLR41819028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021615s021lbl.pdf 2/10/2015
AP02/9/2015SLR41831028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021615Orig1s21,021169Orig1s30,021224Orig1s28ltr.pdf 2/12/2015
AP012/15/2015SLR44792029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021169Orig1s031,021224Orig1s029,021615Orig1s022ltr.pdf 12/17/2015
AP012/15/2015SLR44803029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021169s031-021224s029-021615s022lbl.pdf 12/17/2015




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