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FDA Drug Application 020346 by J AND J CONSUMER INC

Application Number020346
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 formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/27/1996N       
AP04/18/1997SCS       
AP05/15/1998SE1444002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20346s002ltr.pdf 5/15/1998
AP05/15/1998SE1445002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19835-S005_Zyrtec.pdf 5/15/1998
AP010/21/1997SCP       
AP06/10/1998SCS       
AP03/4/1999SCS       
AP02/25/2000SLR       
AP010/21/2002SE521623008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020346_S008_ZYRTEC TABLETS.pdf 1/12/2009
AP010/21/2002SE52242008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19835se5-015,20346se5-008LTR.pdf 10/21/2002
AP010/21/2002SE52243008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19835s15,%2020346s8lbl.pdf 10/21/2002
AP07/19/2002SCS       
AP03/17/2004SLR21624011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020346_S011_ZYRTEC SYRUP.pdf 1/12/2009
AP03/17/2004SLR8023011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19835slr016,21150slr005,30346slr011ltr.pdf 3/24/2004
AP03/17/2004SLR8272011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19835slr016,21150slr005,30346slr011_zyrtec_lbl.pdf 4/5/2004




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