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FDA Drug Application 019835 by J AND J CONSUMER INC

Application Number019835
Application Type New Drug Application
Sponsor ApplicantJ AND J CONSUMER INC
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
AP012/8/1995N       
AP05/23/1996SCS       
AP09/23/1996SLR       
AP011/14/1996SCS       
AP011/1/1996SLR       
AP05/15/1998SE1467005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19835s005ltr.pdf 5/15/1998
AP05/15/1998SE1468005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19835-S005_Zyrtec.pdf 5/15/1998
AP05/22/1998SCS       
AP01/27/1999SCM       
AP07/9/1999SCM       
AP02/4/2000SCP       
AP02/25/2000SLR       
AP02/1/2000SCM       
AP09/19/2000SCS       
AP010/21/2002SE521615015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019835_S015_ZYRTEC TABLETS.pdf 1/12/2009
AP010/21/2002SE52240015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19835se5-015,20346se5-008LTR.pdf 10/21/2002
AP010/21/2002SE52241015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19835s15,%2020346s8lbl.pdf 10/21/2002
AP03/17/2004SLR8021016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19835slr016,21150slr005,30346slr011ltr.pdf 3/24/2004
AP03/17/2004SLR8270016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19835slr016,21150slr005,30346slr011_zyrtec_lbl.pdf 4/5/2004
AP03/17/2004SLR21616016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019835_S016_ZYRTEC SYRUP_.pdf 1/12/2009
AP04/4/2006SCF13880020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019835s020ltr.pdf 4/7/2006
AP011/16/2007SE618575022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019835s022_CKD.pdf 11/26/2007
AP011/16/2007SE619865022   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/019835s022_021621s005TOC.cfm 5/21/2008
AP011/25/2008SCM21295025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019835s025ltr.pdf 11/28/2008
AP02/26/2010SLR       
AP02/26/2010SLR24951028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019835s028ltr.pdf 3/4/2010
AP01/26/2012SLR31584029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019835s029ltr.pdf 1/30/2012
AP03/13/2012SLR32110030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019835s030ltr.pdf 3/15/2012
AP09/10/2012SLR33699032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019835Orig1s032ltr.pdf 9/11/2012
AP09/10/2012SLR34604032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019835s032lbl.pdf 12/12/2012
AP09/26/2014SCM       
AP01/20/2015SCM       
AP04/4/2016SCM       




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