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FDA Drug Application 019824 by MEDIMETRIKS PHARMS

Application Number019824
Application Type New Drug Application
Sponsor ApplicantMEDIMETRIKS 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
AP012/30/1988N       
AP05/8/1989SLR       
AP09/11/1990SCS       
AP02/23/1995SLR       
AP011/17/1995SCS       
AP06/9/1998SCM       
AP03/26/2003SLR4648008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19824slr008_loprox_lbl.pdf 3/28/2003
AP03/26/2003SLR4649008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19824slr008ltr.pdf 3/28/2003
AP03/26/2003SLR4650009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19824slr009_loprox_lbl.pdf 3/28/2003
AP03/26/2003SLR4652009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19824slr009ltr.pdf 3/28/2003
AP06/28/2013SLR36411023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018748Orig1s024,019824Orig1s023,020519Orig1s016ltr.pdf 7/2/2013
AP06/28/2013SLR36526023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018748s024,019824s023,020519s016lbl.pdf 7/11/2013
AP010/5/2016SCM       




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