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FDA Drug Application 021135 by LUITPOLD

Application Number021135
Application Type New Drug Application
Sponsor ApplicantLUITPOLD
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
AP011/6/2000N2262000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21135ltr.pdf 11/13/2000
AP011/6/2000N9613000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21135lbl.pdf 6/29/2004
AP011/6/2000N9614000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21135_Venofer.cfm 6/29/2004
AP02/13/2001SLR       
AP01/22/2002SCS       
AP012/5/2002SCS       
AP07/26/2002SCS5838005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21135se2-005ltr.pdf 6/8/2003
AP07/26/2002SCS5890005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21135se2-005ltr.pdf 6/8/2003
AP06/2/2003SE26136006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21135se2-006ltr.pdf 7/24/2003
AP06/17/2005SE120332008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021135_S008_VENOFER.pdf 7/30/2008
AP16/17/2005S20332008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021135_S008_VENOFER.pdf 7/30/2008
AP06/17/2005SE111845008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021135s008ltr.pdf 6/21/2005
AP16/17/2005S11845008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021135s008ltr.pdf 6/21/2005
AP06/17/2005SE111850008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021135s008lbl.pdf 6/21/2005
AP16/17/2005S11850008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021135s008lbl.pdf 6/21/2005
AP03/29/2005SCP11341010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021135s010ltr.pdf 3/31/2005
AP010/17/2005SE112888013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021135s013ltr.pdf 10/19/2005
AP010/17/2005SE112900013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021135s013lbl.pdf 10/19/2005
AP12/9/2007SCP15864015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021135s015lbl.pdf 2/21/2007
AP012/3/2007SLR18663017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021135s017lbl.pdf 12/14/2007
AP012/3/2007SLR18864017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021135s017ltr.pdf 1/9/2008
AP06/22/2011SLR29303020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021135s020ltr.pdf 6/28/2011
AP06/22/2011SLR29349020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021135s020lbl.pdf 6/29/2011
AP03/29/2013SCM35622023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021135s023lbl.pdf 4/1/2013
AP09/21/2012S33822024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021135Orig1s024ltr.pdf 9/24/2012
AP09/21/2012S33839024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021135s024lbl.pdf 9/25/2012
AP03/2/2016SCM       
AP06/13/2014SCM       
AP05/13/2015SCM       
AP06/13/2016SCM       
AP05/27/2016SCM       




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