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FDA Drug Application 020677 by MYLAN

Application Number020677
Application Type New Drug Application
Sponsor ApplicantMYLAN
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
AP012/19/1996N       
AP010/19/1999SLR10914001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-677s001s002_Zagam.cfm 1/6/2005
AP010/19/1999SLR10915002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-677s001s002_Zagam.cfm 1/6/2005
AP012/10/1999SCM10913003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-677s003_Zagam.cfm 1/6/2005
AP010/2/2002SLR2024004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20677slr004ltr.pdf 10/2/2002
AP010/2/2002SLR2025004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20677s4lbl.pdf 10/2/2002
AP05/11/2001SCM       
AP04/4/2003SLR4932006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020677s006lbl.pdf 4/7/2003
AP04/4/2003SLR5380006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20677slr006ltr.pdf 4/18/2003




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