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FDA Drug Application 074539 by PHARMACHEMIE

Application Number074539
Application Type Abbreviated New Drug Application
Sponsor ApplicantPHARMACHEMIE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/31/2003N5565000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/74539ta3.pdf 5/2/2003
AP03/31/2003N9441000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/74539ltr.pdf 6/18/2004
AP03/31/2003N12127000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/074539.PDF 7/22/2005
TA14/3/1997TA5565000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/74539ta3.pdf 5/2/2003
TA14/3/1997TA9441000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/74539ltr.pdf 6/18/2004
TA14/3/1997TA12127000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/074539.PDF 7/22/2005
TA23/9/1999TA5565000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/74539ta3.pdf 5/2/2003
TA23/9/1999TA9441000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/74539ltr.pdf 6/18/2004
TA23/9/1999TA12127000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/074539.PDF 7/22/2005
TA33/21/2002TA5565000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/74539ta3.pdf 5/2/2003
TA33/21/2002TA9441000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/74539ltr.pdf 6/18/2004
TA33/21/2002TA12127000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/074539.PDF 7/22/2005
AP45/31/2000N5565000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/74539ta3.pdf 5/2/2003
AP45/31/2000N9441000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/74539ltr.pdf 6/18/2004
AP45/31/2000N12127000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/074539.PDF 7/22/2005




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