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FDA Drug Application 019193 by METHAPHARM

Application Number019193
Application Type New Drug Application
Sponsor ApplicantMETHAPHARM
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/31/1986N       
AP06/17/1988SLR       
AP01/6/1995SCS       
AP09/29/1993SCS       
AP03/6/1996SCS       
AP03/5/1996SCM       
AP04/14/1998SCS       
AP05/21/1998SCM       
AP03/8/2002SCM       
AP07/28/2008SLR20325013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019193s013ltr.pdf 7/30/2008
AP07/28/2008SLR20596013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019193s013lbl.pdf 8/13/2008
AP08/29/2016SCM46951017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019193s017lbl.pdf 9/2/2016




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