Back to FDA Applications sponsored by SPECIALITY EUROPEAN

FDA Drug Application 021320 by SPECIALITY EUROPEAN

Application Number021320
Application Type New Drug Application
Sponsor ApplicantSPECIALITY EUROPEAN
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/25/2003N7027000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21320ltr.pdf 12/2/2003
AP011/25/2003N7033000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21320_plenaxis_lbl.pdf 12/2/2003
AP011/25/2003N7835000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-320_Plenaxis.cfm 3/8/2004
AP09/8/2005SLR12764002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021320s002ltr.pdf 9/14/2005
AP09/8/2005SLR12778002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021320s002lbl.pdf 9/14/2005




Back to FDA Applications sponsored by SPECIALITY EUROPEAN