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FDA Drug Application 076314 by MYLAN

Application Number076314
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
TA04/23/2003TA14824000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/76314ltr.pdf 9/15/2006
TA19/11/2006TA14824000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/76314ltr.pdf 9/15/2006
AP29/11/2006N14824000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/76314ltr.pdf 9/15/2006
TA37/27/2007TA14824000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/76314ltr.pdf 9/15/2006
AP43/27/2009N14824000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/76314ltr.pdf 9/15/2006
TA04/23/2003TA17412000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/76314s000_TA_ltr.pdf 7/30/2007
TA19/11/2006TA17412000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/76314s000_TA_ltr.pdf 7/30/2007
AP29/11/2006N17412000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/76314s000_TA_ltr.pdf 7/30/2007
TA37/27/2007TA17412000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/76314s000_TA_ltr.pdf 7/30/2007
AP43/27/2009N17412000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/76314s000_TA_ltr.pdf 7/30/2007
TA04/23/2003TA19038000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107834.htm 2/1/2008
TA19/11/2006TA19038000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107834.htm 2/1/2008
AP29/11/2006N19038000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107834.htm 2/1/2008
TA37/27/2007TA19038000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107834.htm 2/1/2008
AP43/27/2009N19038000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107834.htm 2/1/2008
TA04/23/2003TA22250000   http://www.fda.gov/cder/drug/infopage/antiepileptics/default.htm 4/14/2009
TA19/11/2006TA22250000   http://www.fda.gov/cder/drug/infopage/antiepileptics/default.htm 4/14/2009
AP29/11/2006N22250000   http://www.fda.gov/cder/drug/infopage/antiepileptics/default.htm 4/14/2009
TA37/27/2007TA22250000   http://www.fda.gov/cder/drug/infopage/antiepileptics/default.htm 4/14/2009
AP43/27/2009N22250000   http://www.fda.gov/cder/drug/infopage/antiepileptics/default.htm 4/14/2009




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