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FDA Drug Application 021065 by APIL

Application Number021065
Application Type New Drug Application
Sponsor ApplicantAPIL
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
AP010/15/1999N1088000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21065LTR.PDF 10/15/1999
AP010/15/1999N1089000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21065LBLA.PDF 10/15/1999
AP010/15/1999N1845000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21065_Femhrt.cfm 10/15/1999
AP010/15/1999N4718000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21065LBLPATIENT.PDF 10/15/1999
AP03/7/2000SCM       
AP07/3/2000SCM       
AP04/20/2000SLR       
AP07/14/2000SLR       
AP09/14/2000SCM       
AP012/19/2000SCS       
AP01/20/2004SLR7591009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21065slr009ltr.pdf 1/22/2004
AP01/20/2004SLR7615009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21065slr009_femhrt_lbl.pdf 1/22/2004
AP01/14/2005SE211006012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21065s012ltr.pdf 1/21/2005
AP01/14/2005SE211007012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21065s012lbl.pdf 1/21/2005
AP01/8/2014SLR38245020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021065Orig1s020ltr.pdf 1/10/2014
AP01/8/2014SLR38248020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021065s020lbl.pdf 1/10/2014
AP09/13/2013SCM       
AP07/15/2013SCM       
AP03/25/2014SCM       




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