Back to FDA Applications sponsored by MYLAN

FDA Drug Application 076122 by MYLAN

Application Number076122
Application Type Abbreviated New Drug Application
Sponsor ApplicantMYLAN
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
TA01/15/2002TA5169000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76122tapd.pdf 4/10/2003
TA01/15/2002TA12065000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/076122.pdf 7/22/2005
TA01/15/2002TA12419000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109344.htm 8/1/2005
AP16/19/2003N5169000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76122tapd.pdf 4/10/2003
AP16/19/2003N12065000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/076122.pdf 7/22/2005
AP16/19/2003N12419000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109344.htm 8/1/2005




Back to FDA Applications sponsored by MYLAN