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FDA Drug Application 020114 by MEDA PHARMS

Application Number020114
Application Type New Drug Application
Sponsor ApplicantMEDA 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
AP011/1/1996N       
AP09/29/1997SLR       
AP02/16/1999SLR       
AP010/13/2000SCM       
AP05/30/2000SE11335005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20114S5LTR.PDF 5/30/2000
AP09/15/2000SE51464006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20114S06ltr.pdf 9/15/2000
AP09/15/2000SE58755006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20114S006_Astelin.cfm 5/27/2004
AP06/27/2001SCS       
AP02/17/2006SE2       
AP08/10/2007SLR17607017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020114s017ltr.pdf 8/14/2007
AP01/20/2012SLR31460023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020114s023ltr.pdf 1/23/2012
AP01/20/2012SLR31505023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020114s023lbl.pdf 1/24/2012
AP03/13/2014SCM       
AP010/23/2014SLR40875026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020114Orig1s026ltr.pdf 10/24/2014
AP010/23/2014SLR40984026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020114s026lbl.pdf 11/13/2014




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