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FDA Drug Application 021211 by ORGANON USA INC

Application Number021211
Application Type New Drug Application
Sponsor ApplicantORGANON USA INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/23/2004N8118000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21211ltr.pdf 3/28/2004
AP03/23/2004N8233000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21211_Follistim_lbl.pdf 4/5/2004
AP03/23/2004N14527000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021211s000_FollistimTOC.cfm 7/25/2006
AP02/11/2005SCS11123002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21211s002ltr.pdf 2/17/2005
AP02/11/2005SCS11131002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21211s002lbl.pdf 2/17/2005
AP06/28/2010SE125834007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021211s007lbl.pdf 6/28/2010
AP06/28/2010SE125882007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021211s007ltr.pdf 7/1/2010
AP08/22/2011SE829841011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021211s011lbl.pdf 8/22/2011
AP08/22/2011SE829848011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021211s011ltr.pdf 8/24/2011
AP011/9/2015SCM       




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