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FDA Drug Application 021324 by PERRIGO PHARMA INTL

Application Number021324
Application Type New Drug Application
Sponsor ApplicantPERRIGO PHARMA INTL
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
AP010/2/2001N4685000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-324_Entocort_Approv.pdf 10/2/2001
AP010/2/2001N4686000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21324lbl.pdf 10/2/2001
AP010/2/2001N4687000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-324_Entocort.cfm 10/2/2001
AP010/2/2001N5590000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21324PPIlbl.pdf 5/7/2003
AP08/9/2002SCS8964001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21324scs001ltr.pdf 6/3/2004
AP08/14/2002SCE       
AP010/3/2002SCS8963003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21324scs003ltr.pdf 6/3/2004
AP03/13/2003SCM4498004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21324scm004ltr.pdf 3/26/2003
AP04/29/2005SE511569005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021324s005ltr.pdf 5/3/2005
AP04/29/2005SE511573005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021324s005lbl.pdf 5/3/2005
AP06/22/2009SLR22815008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021324s008ltr.pdf 6/24/2009
AP06/22/2009SLR22818008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021324s008lbl.pdf 6/24/2009
AP012/20/2011SLR31213009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021324s009ltr.pdf 12/22/2011
AP012/20/2011SLR31230009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021324s009lbl.pdf 12/23/2011
AP04/29/2016SE845843012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021324s012s013lbl.pdf 5/3/2016
AP04/29/2016SE845848012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021324Orig1s012,s013ltr.pdf 5/3/2016
AP04/29/2016SE845844013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021324s012s013lbl.pdf 5/3/2016
AP04/29/2016SE845849013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021324Orig1s012,s013ltr.pdf 5/3/2016
AP010/5/2016SCM       




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