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FDA Drug Application 019853 by ATON

Application Number019853
Application Type New Drug Application
Sponsor ApplicantATON
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/4/1970N       
AP08/21/1987SCE       
AP08/25/1987SLR       
AP01/5/1989SLR       
AP01/9/1989SLR       
AP010/4/1988SCM       
AP011/20/2003SLR6969007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19853slr007,011ltr.pdf 11/25/2003
AP08/18/1994SCS       
AP03/1/1996SCM       
AP011/20/2003SLR6970011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19853slr007,011ltr.pdf 11/25/2003
AP010/26/2004SLR10473012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19853s012,014ltr.pdf 10/29/2004
AP010/26/2004SLR10510012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19853s012,014lbl.pdf 11/1/2004
AP05/27/2003SLR5801013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19853slr013ltr.pdf 6/8/2003
AP05/27/2003SLR5874013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19853slr013_cuprimine_lbl.pdf 6/8/2003
AP010/26/2004SLR10511014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19853s012,014lbl.pdf 11/1/2004
AP010/26/2004SLR10474014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19853s012,014ltr.pdf 10/29/2004




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