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FDA Drug Application 021546 by SCHERING

Application Number021546
Application Type New Drug Application
Sponsor ApplicantSCHERING
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/29/2003N6402000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21546ltr.pdf 8/6/2003
AP07/29/2003N9357000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21546_rebetol_lbl.pdf 6/14/2004
AP07/29/2003N11356000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-546_Rebetol.cfm 4/8/2005
AP07/29/2003N15845000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089017.pdf 2/20/2007
AP011/6/2009SLR23902001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021546s001,020903s042s043s044s045lbl.pdf 11/16/2009
AP011/6/2009SLR24559001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020903s042,043,044,045,021546s001ltr.pdf 1/20/2010
AP010/28/2010SLR26829002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020903s046,021546s002MedGuide.pdf 10/29/2010
AP010/28/2010SLR26830002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020903s046,021546s002lbl.pdf 10/29/2010
AP010/28/2010SLR26882002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020903s046,021546s002ltr.pdf 11/3/2010
AP05/6/2011SLR28773004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020903s048,021546s004ltr.pdf 5/10/2011
AP09/25/2013SCM       
AP02/6/2013SLR35102006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020903Orig1s050,021546Orig1s006ltr.pdf 2/8/2013
AP02/6/2013SLR35104006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020903s050,021546s006lbl.pdf 2/8/2013
AP05/31/2013SLR36200007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020903Orig1s051,021546Orig1s007ltr.pdf 6/4/2013
AP05/31/2013SLR36209007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020903s051,021546s007lbl.pdf 6/4/2013
AP011/15/2013SLR37844008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020903Orig1s052,021546Orig1s008ltr.pdf 11/18/2013
AP011/15/2013SLR37898008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020903s052,021546s008lbl.pdf 11/22/2013
AP05/21/2015SLR42883009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020903Orig1s053,021546Orig1s009ltr.pdf 5/22/2015
AP05/21/2015SLR42911009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020903s053,021546s009lbl.pdf 5/27/2015




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