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FDA Drug Application 020519 by CNTY LINE PHARMS

Application Number020519
Application Type New Drug Application
Sponsor ApplicantCNTY LINE 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
AP07/21/1997N       
AP02/25/1998SCM       
AP02/25/2000SCF       
AP012/10/1999SCS       
AP07/1/1999SCP       
AP03/26/2003SLR4656005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20519slr005_loprox_lbl.pdf 3/28/2003
AP03/26/2003SLR5285005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20519slr005ltr.pdf 4/15/2003
AP06/28/2013SLR36413016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018748Orig1s024,019824Orig1s023,020519Orig1s016ltr.pdf 7/2/2013
AP06/28/2013SLR36527016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018748s024,019824s023,020519s016lbl.pdf 7/11/2013




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