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FDA Drug Application 021197 by EMD SERONO INC

Application Number021197
Application Type New Drug Application
Sponsor ApplicantEMD SERONO INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/11/2000N1427000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21197ltr.pdf 8/11/2000
AP08/11/2000N1428000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21197lbl.pdf 8/11/2000
AP08/11/2000N2386000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-197_Cetrotide.cfm 8/11/2000
AP012/13/2000SCS       
AP04/30/2004SLR8539003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21197slr003,004,005ltr.pdf 5/7/2004
AP04/30/2004SLR8540004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21197slr003,004,005ltr.pdf 5/7/2004
AP04/30/2004SLR8541005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21197slr003,004,005ltr.pdf 5/7/2004
AP04/4/2008SLR19635010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021197s010ltr.pdf 4/10/2008
AP04/4/2008SLR19667010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021197s010lbl.pdf 4/16/2008
AP01/29/2013SCM       
AP03/15/2013SCM       
AP03/13/2013SCM       




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