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FDA Drug Application 020793 by WEST-WARD PHARMS INT

Application Number020793
Application Type New Drug Application
Sponsor ApplicantWEST-WARD PHARMS INT
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New ester, new salt, or other noncovalent derivative
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/21/1999N262000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20793ltr.pdf 9/21/1999
AP09/21/1999N263000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20793lbl.pdf 9/21/1999
AP09/21/1999N12013000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020793_000_CafcitTOC.cfm 7/15/2005
AP04/12/2000SE31437001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20793s1ltr.pdf 4/12/2000
AP04/12/2000SE31438001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20793s1lbl.pdf 4/12/2000
AP04/14/2000SCM       
AP01/18/2002SLR2288003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20793s3ltr.pdf 1/18/2002
AP02/8/2002SLR2287004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20793s4ltr.pdf 2/8/2002
AP03/8/2002SCM       
AP06/11/2010SLR25748009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020793s009ltr.pdf 6/16/2010
AP06/11/2010SLR44833009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020793s009lbl.pdf 12/22/2015
AP012/23/2014SCM       




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