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FDA Drug Application 202088 by CITIUS PHARMS

Application Number202088
Application Type New Drug Application
Sponsor ApplicantCITIUS 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
AP06/13/2011N32065000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202088_suprenza_toc.cfm 3/9/2012
AP13/27/2012N32065000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202088_suprenza_toc.cfm 3/9/2012
AP06/13/2011N32066000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202088Origs1s000SumR.pdf 3/9/2012
AP13/27/2012N32066000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202088Origs1s000SumR.pdf 3/9/2012
AP06/13/2011N32269000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202088s000_2lbl.pdf 3/28/2012
AP13/27/2012N32269000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202088s000_2lbl.pdf 3/28/2012
AP06/13/2011N32283000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202088s000ltr.pdf 3/29/2012
AP13/27/2012N32283000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202088s000ltr.pdf 3/29/2012
AP06/13/2011N36138000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202088_suprenza_toc.cfm 5/24/2013
AP13/27/2012N36138000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202088_suprenza_toc.cfm 5/24/2013
AP06/13/2011N36139000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202088Orig2s000SumR.pdf 5/24/2013
AP13/27/2012N36139000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202088Orig2s000SumR.pdf 5/24/2013
AP06/13/2011N29160000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202088s000ltr.pdf 6/16/2011
AP13/27/2012N29160000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202088s000ltr.pdf 6/16/2011
AP06/13/2011N29181000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202088s000lbl.pdf 6/16/2011
AP13/27/2012N29181000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202088s000lbl.pdf 6/16/2011
AP010/13/2011SLR30337001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202088s001ltr.pdf 10/17/2011
AP010/13/2011SLR30374001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202088s001lbl.pdf 10/20/2011
AP03/27/2012SLR32297002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202088s002ltr.pdf 3/30/2012
AP012/5/2012SLR34567004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202088s004lbl.pdf 12/7/2012
AP012/5/2012SLR34590004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202088Orig1s004ltr.pdf 12/11/2012
AP06/11/2013SLR36280005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202088Orig1s005ltr.pdf 6/12/2013
AP06/11/2013SLR36321005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202088s005lbl.pdf 6/18/2013
AP07/11/2013SLR37433006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202088Orig1s006ltr.pdf 10/17/2013
AP07/11/2013SLR37871006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202088Orig1s006lbl.pdf 11/20/2013
AP02/18/2014SCM       




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