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FDA Drug Application 021241 by JANSSEN PHARMS

Application Number021241
Application Type New Drug Application
Sponsor ApplicantJANSSEN PHARMS
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
AP08/22/2002N3077000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21241ltr.pdf 8/22/2002
AP08/22/2002N3078000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21241lbl.pdf 8/22/2002
AP08/22/2002N10084000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021241_sooo_Orthotricyclene.cfm 8/26/2004
AP01/3/2003SCM14439003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021241_s003_OrthoTOC.cfm 7/11/2006
AP06/18/2012SLR32956017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017735s107,17919s089,018985s053,019653s048,19697s044,20301s027,21241s017ltr.pdf 6/20/2012
AP06/18/2012SLR33193017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021241s017lbl.pdf 7/13/2012
AP07/31/2015SLR43557025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021241Orig1s025ltr.pdf 8/3/2015
AP07/31/2015SLR43567025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021241s025lbl.pdf 8/4/2015




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