Back to FDA Applications sponsored by CENTOCOR ORTHO BIOTECH INC

FDA Drug Application 125261 by CENTOCOR ORTHO BIOTECH INC

Application Number125261
Application Type Biologic License Application
Sponsor ApplicantCENTOCOR ORTHO BIOTECH INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/25/2009N23459000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125261lbl.pdf 9/29/2009
AP09/25/2009N23461000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM187066.pdf 9/29/2009
AP09/25/2009N23526000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125261s000ltr.pdf 10/5/2009
AP09/25/2009N23704000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=50 10/30/2009
AP09/25/2009N24587000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125261s000TOC.cfm 1/22/2010
AP09/25/2009N24588000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125261s000_SumR.pdf 1/22/2010
AP012/30/2009S246470001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125261s0001ltr.pdf 1/27/2010
AP012/30/2009S246760001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125261s001lbl.pdf 1/29/2010
AP05/31/2012SE8327920049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125261s0049ltr.pdf 6/4/2012
AP05/31/2012SE8328250049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125261s0049lbl.pdf 6/6/2012
AP05/31/2012SE8328260049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125261s0049mg.pdf 6/6/2012
AP04/6/2012S323940058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125261s0058ltr.pdf 4/11/2012
AP06/14/2012S329160059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125261s0059ltr.pdf 6/15/2012
AP06/14/2012S329280059   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125261s0059lbl.pdf 6/18/2012
AP06/14/2012S329290059   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125261s0059mg.pdf 6/18/2012
AP05/2/2012S326220063   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125261s0063ltr.pdf 5/4/2012
AP010/20/2010S27414013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125261s013ltr.pdf 12/28/2010
AP010/20/2010S32372013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125261s0013lbl.pdf 4/9/2012
AP010/20/2010S32373013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125261s0013mg.pdf 4/9/2012
AP05/21/2013SE836125086   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125261Orig1s086ltr.pdf 5/23/2013
AP05/21/2013SE836131086   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125261s086lbl.pdf 5/23/2013
AP01/25/2013SLR35006091   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125261Orig1s091ltr.pdf 1/30/2013
AP01/25/2013SLR35015091   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125261s091lbl.pdf 1/30/2013
AP04/29/2013SLR35896099   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125261Orig1s099ltr.pdf 5/1/2013
AP04/29/2013SLR35921099   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125261s099lbl.pdf 5/1/2013
AP09/20/2013SE837187103   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125261Orig1s103ltr.pdf 9/23/2013
AP09/20/2013SE837203103   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125261s103lbl.pdf 9/24/2013
AP03/4/2014SLR38667114   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125261s114lbl.pdf 3/5/2014
AP03/4/2014SLR38676114   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125261Orig1s114ltr.pdf 3/6/2014




Back to FDA Applications sponsored by CENTOCOR ORTHO BIOTECH INC