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FDA Drug Application 021751 by HAMELN PHARMA PLUS

Application Number021751
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
AP08/11/2004N9994000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21749,21751ltr.pdf 8/11/2004
AP08/11/2004N9998000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021751lbl.pdf 8/11/2004
AP08/11/2004N10436000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-751_21-749_Pentetate.cfm 10/20/2004
AP08/4/2005SLR12555002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021749s002,021751s002ltr.pdf 8/8/2005
AP03/21/2013SLR35494008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021751Orig1s008ltr.pdf 3/22/2013
AP03/21/2013SLR35525008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021751s008lbl.pdf 3/26/2013




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