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FDA Drug Application 021388 by BRYAN

Application Number021388
Application Type New Drug Application
Sponsor ApplicantBRYAN
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/15/2003N7257000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21388_SterileTalclbl.pdf 12/17/2003
AP012/15/2003N7288000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21388ltr.pdf 12/19/2003
AP012/15/2003N8522000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-388_SterileTalc.cfm 5/6/2004
AP06/13/2014SLR39551002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021388Orig1s002ltr.pdf 6/17/2014
AP06/13/2014SLR39564002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021388s002lbl.pdf 6/17/2014




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