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FDA Drug Application 018748 by MEDIMETRIKS PHARMS

Application Number018748
Application Type New Drug Application
Sponsor ApplicantMEDIMETRIKS PHARMS
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
AP012/30/1982N       
AP01/16/1985SLR       
AP05/29/1986SCS       
AP04/26/1989SCP       
AP02/23/1995SLR       
AP09/15/1998SCM       
AP03/26/2003SLR4644010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18748slr010_loprox_lbl.pdf 3/28/2003
AP03/26/2003SLR4645010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18748slr010ltr.pdf 3/28/2003
AP08/17/2001SCF5254011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18748s11lbl.pdf 4/15/2003
AP06/28/2013SLR36410024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018748Orig1s024,019824Orig1s023,020519Orig1s016ltr.pdf 7/2/2013
AP06/28/2013SLR36525024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018748s024,019824s023,020519s016lbl.pdf 7/11/2013
AP01/14/2016SCM       




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