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FDA Drug Application 103575 by CENTOCOR INC

Application Number103575
Application Type Biologic License Application
Sponsor ApplicantCENTOCOR 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
AP012/16/1993N       
AP011/5/1997S81261008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1997/abcicen110597-ltr.pdf 3/29/2004
AP011/5/1997S81271008   http://www.accessdata.fda.gov/drugsatfda_docs/label/1997/abcicen110597-lab.pdf 3/29/2004
AP011/5/1997S81281008   http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm093336.htm 3/29/2004
AP011/5/1997S81291010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1997/abcicen110597-ltr.pdf 3/29/2004
AP011/5/1997S81301010   http://www.accessdata.fda.gov/drugsatfda_docs/label/1997/abcicen110597-lab.pdf 3/29/2004
AP011/5/1997S81311010   http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm093336.htm 3/29/2004
AP011/21/2003S70445022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103575-5022ltr.pdf 12/4/2003
AP011/21/2003S70455025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103575-5025ltr.pdf 12/4/2003
AP011/25/2013SLR379385126   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103575s5126lbl.pdf 11/26/2013
AP011/25/2013SLR379545126   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103575Orig1s5126ltr.pdf 11/27/2013




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