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FDA Drug Application 021749 by HAMELN PHARMA PLUS

Application Number021749
Application Type New Drug Application
Sponsor ApplicantHAMELN PHARMA PLUS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/11/2004N9987000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021749lbl.pdf 8/11/2004
AP08/11/2004N9988000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21749,21751ltr.pdf 8/11/2004
AP08/11/2004N9990000Questions and Answers  http://www.fda.gov/Drugs/EmergencyPreparedness/BioterrorismandDrugPreparedness/ucm130314.htm 8/11/2004
AP08/11/2004N9991000   http://www.fda.gov/Drugs/EmergencyPreparedness/BioterrorismandDrugPreparedness/ucm130311.htm 8/11/2004
AP08/11/2004N10435000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-749_21-751_Pentetate.cfm 10/20/2004
AP08/4/2005SLR12556002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021749s002,021751s002ltr.pdf 8/8/2005
AP03/21/2013SLR35493008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021749Orig1s008ltr.pdf 3/22/2013
AP03/21/2013SLR35526008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021749s008lbl.pdf 3/26/2013
AP02/16/2015SCM       
AP07/8/2016SCM       




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