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FDA Drug Application 021457 by TEVA BRANDED PHARM

Application Number021457
Application Type New Drug Application
Sponsor ApplicantTEVA BRANDED PHARM
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/29/2004N10551000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21457ltr.pdf 11/8/2004
AP010/29/2004N10564000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21457lbl.pdf 11/8/2004
AP010/29/2004N16327000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021457s000TOC.cfm 4/30/2007
AP05/2/2005SCS11583001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021457s001ltr.pdf 5/4/2005
AP05/2/2005SCS11586001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021457s001lbl.pdf 5/4/2005
AP011/21/2005SLR13149002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021457s002,004lbl.pdf 11/30/2005
AP011/21/2005SLR13170002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021457s002,004ltr.pdf 11/30/2005
AP02/3/2006SE113601003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021457s003Exclultr.pdf 2/8/2006
AP02/3/2006SE115670003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021457s003lbl.pdf 1/17/2007
AP011/21/2005SLR13171004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021457s002,004ltr.pdf 11/30/2005
AP011/21/2005SLR13150004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021457s002,004lbl.pdf 11/30/2005
AP09/16/2008SE520788013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021457s013ltr.pdf 9/17/2008
AP09/16/2008SE520856013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021457s013lbl.pdf 9/19/2008
AP08/17/2010SLR26244021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021457s021lbl.pdf 8/19/2010
AP08/17/2010SLR26266021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021457s021ltr.pdf 8/20/2010
AP012/8/2010SLR27286022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021457s022ltr.pdf 12/15/2010
AP012/10/2010SCM       
AP03/7/2012SCM34494026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021457s026lbl.pdf 11/29/2012
AP012/10/2012SCM       
AP01/9/2013SCM       
AP03/23/2013SCM       
AP01/8/2014SCM       
AP05/20/2016SCM       




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