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FDA Drug Application 021367 by APIL

Application Number021367
Application Type New Drug Application
Sponsor ApplicantAPIL
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New ester, new salt, or other noncovalent derivative
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/20/2003N4445000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021367lbl.pdf 3/21/2003
AP03/20/2003N4482000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21367ltr.pdf 3/26/2003
AP03/20/2003N6127000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021367TOC.cfm 7/16/2003
AP03/11/2005SLR11244002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21367s002ltr.pdf 3/14/2005
AP03/11/2005SLR11249002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21367s002lbl.pdf 3/14/2005
AP08/16/2005SLR12629005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021367s005ltr.pdf 8/19/2005
AP08/16/2005SLR12648005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021367s005lbl.pdf 8/19/2005
AP02/14/2007SLR15867007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021367s007lbl.pdf 2/21/2007
AP02/14/2007SLR15890007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021367s007ltr.pdf 2/23/2007
AP05/20/2009SLR22614009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021367s009lbl.pdf 5/25/2009
AP05/20/2009SLR22631009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021367s009ltr.pdf 5/27/2009
AP05/29/2014SLR39400013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021367s013lbl.pdf 5/30/2014
AP05/29/2014SLR39419013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021367Orig1s013ltr.pdf 6/2/2014




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