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FDA Drug Application 021641 by TEVA

Application Number021641
Application Type New Drug Application
Sponsor ApplicantTEVA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/16/2006N14129000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021641lbl.pdf 5/18/2006
AP05/16/2006N14138000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021641s000LTR.pdf 5/21/2006
AP05/16/2006N14518000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021641s000_AzilectTOC.cfm 7/24/2006
AP012/9/2009SLR24234002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021641s002s003s004s005s007s008s010lbl.pdf 12/10/2009
AP012/9/2009SLR24621002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021641s002s003s004s005s006s007s008s010ltr.pdf 1/26/2010
AP012/9/2009SLR24235003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021641s002s003s004s005s007s008s010lbl.pdf 12/10/2009
AP012/9/2009SLR24622003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021641s002s003s004s005s006s007s008s010ltr.pdf 1/26/2010
AP012/9/2009SLR24236004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021641s002s003s004s005s007s008s010lbl.pdf 12/10/2009
AP012/9/2009SLR24623004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021641s002s003s004s005s006s007s008s010ltr.pdf 1/26/2010
AP012/9/2009SLR24237005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021641s002s003s004s005s007s008s010lbl.pdf 12/10/2009
AP012/9/2009SLR24624005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021641s002s003s004s005s006s007s008s010ltr.pdf 1/26/2010
AP012/9/2009SLR24238007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021641s002s003s004s005s007s008s010lbl.pdf 12/10/2009
AP012/9/2009SLR24625007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021641s002s003s004s005s006s007s008s010ltr.pdf 1/26/2010
AP012/9/2009SE824239008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021641s002s003s004s005s007s008s010lbl.pdf 12/10/2009
AP012/9/2009SE824580008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021641S008TOC.cfm 1/22/2010
AP012/9/2009SE824581008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021641S008_SumR.pdf 1/22/2010
AP012/9/2009SE824626008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021641s002s003s004s005s006s007s008s010ltr.pdf 1/26/2010
AP012/9/2009SLR24240010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021641s002s003s004s005s007s008s010lbl.pdf 12/10/2009
AP012/9/2009SLR24627010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021641s002s003s004s005s006s007s008s010ltr.pdf 1/26/2010
AP05/29/2014SLR39398016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021641s016s017lbl.pdf 5/30/2014
AP05/29/2014SLR39418016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021641Orig2s016,s017ltr.pdf 6/2/2014
AP05/29/2014SE839399017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021641s016s017lbl.pdf 5/30/2014
AP05/29/2014SE839417017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021641Orig2s016,s017ltr.pdf 6/2/2014
AP07/20/2015SCM       
AP012/9/2015SCM       




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