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FDA Drug Application 021007 by GLAXOSMITHKLINE

Application Number021007
Application Type New Drug Application
Sponsor ApplicantGLAXOSMITHKLINE
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
AP04/15/1999N942000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21007lbl.pdf 4/15/1999
AP04/15/1999N2702000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-007_Agenerase_Approv.pdf 4/15/1999
AP04/15/1999N8590000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21007&21039_Agenerase.cfm 5/26/2004
AP09/22/1999SLR       
AP04/28/2000SLR       
AP04/24/2000SLR       
AP012/22/1999SCM       
AP012/19/2000SLR       
AP05/11/2001SE78593006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/N21-007S006_Agenerase.cfm 5/26/2004
AP05/11/2001SE73057006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/N21-007SE7006_Agenerase_Approv.pdf 5/11/2001
AP05/11/2001SE73058006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/N21-007SE7006_Agenerase_Prntlbl.pdf 5/11/2001
AP012/14/2000SCM       
AP05/9/2001SLR       
AP02/5/2002SE82698010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21039s9s12ltr.pdf 2/5/2002
AP08/2/2002SLR2694011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21007slr011and21039slr010ltr.pdf 8/2/2002
AP08/2/2002SLR2695011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21007s11,21039s10lbl.pdf 8/2/2002
AP02/5/2002SLR2699013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21039s9s12ltr.pdf 2/5/2002
AP010/2/2002SLR2686014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21007slr014,015,21039slr013,014ltr.pdf 10/2/2002
AP010/2/2002SLR2687014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21007s14s15,21039s13s14lbl.pdf 10/2/2002
AP010/2/2002SLR2688015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21007slr014,015,21039slr013,014ltr.pdf 10/2/2002
AP010/2/2002SLR2689015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21007s14s15,21039s13s14lbl.pdf 10/2/2002
AP02/12/2004SLR7765016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21007slr016,21039slr016ltr.pdf 3/2/2004
AP02/12/2004SLR8205016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21007slr016,21039slr016_agenerase_lbl.pdf 4/5/2004
AP011/4/2005SLR13053017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021007s017lbl.pdf 11/16/2005
AP011/4/2005SLR13097017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021007s017ltr.pdf 11/18/2005




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