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FDA Drug Application 020926 by GENZYME

Application Number020926
Application Type New Drug Application
Sponsor ApplicantGENZYME
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/30/1998N611000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20926ltr.pdf 10/30/1998
AP010/30/1998N612000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020926.cfm 7/4/1999
AP010/30/1998N613000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20926lbl.pdf 10/30/1998
AP010/1/1999SCM       
AP05/5/2000SE21378002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20926S2LTR.PDF 5/5/2000
AP010/13/2000SCM       
AP03/15/2002SCS       
AP08/8/2002SCM       
AP02/6/2004SE17802006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20926se1-006,21179se1-002ltr.pdf 3/3/2004




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