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FDA Drug Application 021199 by SANTEN

Application Number021199
Application Type New Drug Application
Sponsor ApplicantSANTEN
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/18/2000N1424000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21199ltr.pdf 8/18/2000
AP08/18/2000N1425000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21199lbl.pdf 8/18/2000
AP08/18/2000N8028000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-199_Quixin.cfm 3/24/2004
AP010/10/2000SCS       
AP04/18/2002SLR3495002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21199s2ltr.pdf 4/18/2002
AP04/18/2002SLR3496002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21199s2lbl.pdf 4/18/2002
AP06/4/2002SCP3493003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21199s003ltr.pdf 6/4/2002
AP06/4/2002SCP3494003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21199s003lbl.pdf 6/4/2002
AP04/11/2005SLR11388004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021199s004,005ltr.pdf 4/12/2005
AP04/11/2005SLR11393004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021199s004,005lbl.pdf 4/12/2005
AP04/11/2005SCP11394005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021199s004,005lbl.pdf 4/12/2005
AP04/11/2005SCP11389005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021199s004,005ltr.pdf 4/12/2005
AP012/3/2014SLR41160014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021199Orig1s014ltr.pdf 12/4/2014
AP012/3/2014SLR41194014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021199s014lbl.pdf 12/10/2014




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