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FDA Drug Application 021039 by GLAXOSMITHKLINE

Application Number021039
Application Type New Drug Application
Sponsor ApplicantGLAXOSMITHKLINE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority*
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/15/1999N2703000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-007_Agenerase_Approv.pdf 4/15/1999
AP04/15/1999N2704000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-007_Agenerase_prntlbl.pdf 4/15/1999
AP04/15/1999N8591000   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       
AP05/11/2001SE73059006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/N21-007SE7006_Agenerase_Approv.pdf 5/11/2001
AP05/11/2001SE73060006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/N21-007SE7006_Agenerase_Prntlbl.pdf 5/11/2001
AP05/11/2001SE78592006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/N21-007S006_Agenerase.cfm 5/26/2004
AP05/9/2001SLR       
AP02/5/2002SE82700009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21039s9s12ltr.pdf 2/5/2002
AP08/2/2002SLR2696010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21007slr011and21039slr010ltr.pdf 8/2/2002
AP08/2/2002SLR2697010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21007s11,21039s10lbl.pdf 8/2/2002
AP02/5/2002SLR2701012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21039s9s12ltr.pdf 2/5/2002
AP010/2/2002SLR2690013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21007slr014,015,21039slr013,014ltr.pdf 10/2/2002
AP010/2/2002SLR2691013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21007s14s15,21039s13s14lbl.pdf 10/2/2002
AP010/2/2002SLR2692014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21007slr014,015,21039slr013,014ltr.pdf 10/2/2002
AP010/2/2002SLR2693014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21007s14s15,21039s13s14lbl.pdf 10/2/2002
AP012/24/2002SCM       
AP02/12/2004SLR7766016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21007slr016,21039slr016ltr.pdf 3/2/2004
AP02/12/2004SLR8206016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21007slr016,21039slr016_agenerase_lbl.pdf 4/5/2004
AP011/4/2005SLR13030017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021039s017lbl.pdf 11/8/2005
AP011/4/2005SLR13096017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021039s017ltr.pdf 11/18/2005




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