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FDA Drug Application 020444 by GLAXOSMITHKLINE LLC

Application Number020444
Application Type New Drug Application
Sponsor ApplicantGLAXOSMITHKLINE LLC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/20/1995N       
AP03/18/1996SLR       
AP011/21/1997SCM       
AP04/14/2000SE11150003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20444S03LTR.PDF 4/14/2000
AP04/14/2000SE11151003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20444S03LBL.PDF 4/14/2000
AP04/14/2000SE11849003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-444S003_Flolan.cfm 4/14/2000
AP011/2/1999SLR       
AP09/21/2000SLR       
AP01/17/2002SCM       
AP04/5/2002SCM       
AP06/21/2002SCP       
AP06/21/2002SCM       
AP09/20/2002SCM       
AP03/12/2008SLR19469016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020444s016ltr.pdf 3/17/2008
AP03/12/2008SLR19474016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020444s016lbl.pdf 3/17/2008
AP03/29/2011SLR28407018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020444s018ltr.pdf 3/31/2011
AP03/29/2011SLR28428018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020444s018lbl.pdf 4/1/2011
AP04/17/2015SCM42622021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020444s021lbl.pdf 4/22/2015




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