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FDA Drug Application 021551 by BRAINTREE

Application Number021551
Application Type New Drug Application
Sponsor ApplicantBRAINTREE
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
AP05/10/2004N8637000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21551ltr.pdf 5/26/2004
AP05/10/2004N8726000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21551_halflytely_lbl.pdf 5/27/2004
AP05/10/2004N13189000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021551s000_HalfLytelyTOC.cfm 12/1/2005
AP05/10/2004N26037000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM220644.pdf 7/30/2010
AP02/23/2005SCS11186003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21551s003ltr.pdf 3/3/2005
AP05/18/2006SLR14136005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021551s005ltr.pdf 5/21/2006
AP05/18/2006SLR14150005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021551s005lbl.pdf 5/22/2006
AP09/24/2007SE218031006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021551s006lbl.pdf 9/26/2007
AP09/24/2007SE218050006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021551s006ltr.pdf 9/26/2007
AP07/16/2010SE225981013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021551s013lbl.pdf 7/19/2010
AP07/16/2010SE225997013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021551s013ltr.pdf 7/23/2010
AP07/6/2011SLR29472016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021551s016ltr.pdf 7/12/2011
AP06/3/2013SCM       




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