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FDA Drug Application 203752 by NOVEN

Application Number203752
Application Type New Drug Application
Sponsor ApplicantNOVEN
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/29/2012N34214000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203752Orig1s000ltr.pdf 11/1/2012
AP010/29/2012N34264000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203752lbl.pdf 10/29/2012
AP010/29/2012N35560000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203752_minivelle_toc.cfm 3/28/2013
AP010/29/2012N35561000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203752Orig1s000SumR.pdf 3/28/2013
AP05/21/2014SCM       
AP09/23/2014SE840598004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203752Orig1s004ltr.pdf 9/25/2014
AP09/23/2014SE840618004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203752s004lbl.pdf 9/26/2014
AP04/18/2014SCM       
AP011/10/2014SCM       




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