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FDA Drug Application 021640 by BAUSCH AND LOMB

Application Number021640
Application Type New Drug Application
Sponsor ApplicantBAUSCH AND LOMB
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/5/2004N8552000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21640ltr.pdf 5/7/2004
AP05/5/2004N8562000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21640_vitrase_lbl.pdf 5/7/2004
AP05/5/2004N10090000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-640_Vitrase.cfm 8/27/2004
AP05/5/2004N10880000Additional App Ltr  http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021640_additional_ltr.pdf 10/26/2004
AP012/21/2004SLR10826001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21640s001ltr.pdf 12/29/2004
AP012/21/2004SLR10843001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21640s001lbl.pdf 12/29/2004
AP012/2/2004SLR10738002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21640s002,003lbl.pdf 12/6/2004
AP012/2/2004SLR10730002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21640s002,003ltr.pdf 12/6/2004
AP012/2/2004SCF10731003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21640s002,003ltr.pdf 12/6/2004
AP012/2/2004SCF10739003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21640s002,003lbl.pdf 12/6/2004
AP04/12/2012SLR32436016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021640s016ltr.pdf 4/16/2012
AP04/12/2012SLR32441016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021640s016lbl.pdf 4/17/2012
AP02/11/2014SCM       
AP011/30/2015SCM       
AP02/16/2015SCM       




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