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FDA Drug Application 021098 by BAYER HLTHCARE

Application Number021098
Application Type New Drug Application
Sponsor ApplicantBAYER HLTHCARE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME); New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/11/2001N2020000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-098_Yasmin_Approv.pdf 5/11/2001
AP05/11/2001N2021000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21098lbl.pdf 5/11/2001
AP05/11/2001N2022000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-098_Yasmin.cfm 5/11/2001
AP05/11/2001N30586000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm257168.htm 11/16/2011
AP011/26/2001SCP       
AP011/30/2001SCM       
AP011/30/2001SCM       
AP012/12/2001SCS       
AP05/9/2003SE85629005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021098s005lbl.pdf 5/13/2003
AP05/9/2003SE85774005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21098se8-005ltr.pdf 5/30/2003
AP08/8/2002SCM       
AP04/7/2010SLR25250017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021098s017ltr.pdf 4/9/2010
AP04/7/2010SLR25275017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021098s017lbl.pdf 4/19/2010
AP02/13/2012SE831782019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021098s019lbl.pdf 2/13/2012
AP02/13/2012SE831813019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021098s019ltr.pdf 2/17/2012
AP01/31/2013SCM       
AP04/10/2012SLR32384022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021098s022lbl.pdf 4/10/2012
AP04/10/2012SLR32404022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021098s022,021676s012,022532s004,022574s004ltr.pdf 4/12/2012
AP04/10/2012SLR45094022   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021098Orig1s022.pdf 2/3/2016
AP06/1/2015SLR42970023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021098Orig1s023,022532Orig1s006,022574Orig1s006,021676Orig1s014ltr.pdf 6/3/2015
AP06/1/2015SLR42989023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021098s023lbl.pdf 6/4/2015
AP011/26/2014SCM       
AP09/30/2014SCM       
AP03/8/2016SCM       




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