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FDA Drug Application 022007 by MYLAN SPECLT

Application Number022007
Application Type New Drug Application
Sponsor ApplicantMYLAN SPECLT
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
TA04/27/2007TA16369000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022007s000TAltr.pdf 5/1/2007
TA04/27/2007TA16661000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022007s000ltr.pdf 5/31/2007
TA04/27/2007TA19553000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022007lbl.pdf 3/28/2008
TA04/27/2007TA19554000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm108111.htm 4/1/2008
TA04/27/2007TA22044000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022007_perforomist_toc.cfm 3/19/2009
TA04/27/2007TA25704000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM214444.pdf 6/4/2010
TA04/27/2007TA27999000REMS  http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM245184.pdf 3/1/2011
AP15/11/2007N16369000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022007s000TAltr.pdf 5/1/2007
AP15/11/2007N16661000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022007s000ltr.pdf 5/31/2007
AP15/11/2007N19553000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022007lbl.pdf 3/28/2008
AP15/11/2007N19554000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm108111.htm 4/1/2008
AP15/11/2007N22044000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022007_perforomist_toc.cfm 3/19/2009
AP15/11/2007N25704000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM214444.pdf 6/4/2010
AP15/11/2007N27999000REMS  http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM245184.pdf 3/1/2011
AP06/2/2010SLR25668004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022007s004lbl.pdf 6/2/2010
AP06/2/2010SLR25679004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022007s004ltr.pdf 6/3/2010
AP02/1/2011SLR27756005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022007s005ltr.pdf 2/7/2011
AP01/11/2012SLR31390006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022007s006ltr.pdf 1/17/2012
AP01/11/2012SLR31478006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022007s006lbl.pdf 1/23/2012
AP09/25/2012SLR33926007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022007Orig1s007,s008ltr.pdf 10/2/2012
AP09/25/2012SLR33927008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022007Orig1s007,s008ltr.pdf 10/2/2012
AP03/19/2014SCM       
AP08/29/2016SCM       




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