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FDA Drug Application 020450 by PARKE DAVIS

Application Number020450
Application Type New Drug Application
Sponsor ApplicantPARKE DAVIS
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
AP08/5/1996N       
AP012/26/1996SLR5928001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020450a_s001.pdf 6/17/2003
AP011/20/1998SCM       
AP08/13/2001SLR5462004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20450s4s5lbl.pdf 4/25/2003
AP08/13/2001SLR16655004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020450_s004TOC.cfm 5/29/2007
AP08/13/2001SLR5623005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20450s4s5lbl.pdf 8/31/2001
AP08/13/2001SLR16657005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020450_s005TOC.cfm 5/30/2007
AP01/2/2002SLR       
AP011/13/2011SLR30630008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020450s008s009s016s019lbl.pdf 11/16/2011
AP011/13/2011SLR30645008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020450s008s009s016s019ltr.pdf 11/17/2011
AP011/13/2011SLR30631009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020450s008s009s016s019lbl.pdf 11/16/2011
AP011/13/2011SLR30646009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020450s008s009s016s019ltr.pdf 11/17/2011
AP011/13/2011SLR30632016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020450s008s009s016s019lbl.pdf 11/16/2011
AP011/13/2011SLR30647016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020450s008s009s016s019ltr.pdf 11/17/2011
AP011/13/2011SLR30633019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020450s008s009s016s019lbl.pdf 11/16/2011
AP011/13/2011SLR30648019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020450s008s009s016s019ltr.pdf 11/17/2011
AP03/6/2013SLR35357020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020450Orig1s020ltr.pdf 3/8/2013
AP03/6/2013SLR35380020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020450s020lbl.pdf 3/8/2013
AP08/30/2013SCM       
AP01/3/2014SLR38219023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020450Orig1s023ltr.pdf 1/7/2014
AP01/3/2014SLR38224023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020450s023lbl.pdf 1/7/2014
AP010/22/2013SLR37543024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020450Orig1s024ltr.pdf 10/24/2013
AP010/22/2013SLR37870024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020450Orig1s024lbl.pdf 11/20/2013
AP06/12/2014SLR39544025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020450Orig1s025ltr.pdf 6/17/2014
AP06/12/2014SLR39570025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020450s025lbl.pdf 6/17/2014
AP06/9/2014SCM       
AP06/4/2015SLR43007028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020450Orig1s028ltr.pdf 6/10/2015
AP06/4/2015SLR43026028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020450s028lbl.pdf 6/10/2015
AP03/3/2016SLR45376029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020450Orig1s029ltr.pdf 3/4/2016
AP03/3/2016SLR45377029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020450s029lbl.pdf 3/4/2016
AP06/1/2016SCM       
AP06/16/2016SLR46380031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020450s031lbledt.pdf 6/21/2016




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