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FDA Drug Application 018421 by ROXANE

Application Number018421
Application Type New Drug Application
Sponsor ApplicantROXANE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/23/1980N       
AP05/4/1981SCP       
AP04/29/1982SCP       
AP01/31/1983SLR       
AP03/24/1983SLR       
AP07/23/1984SCF       
AP09/29/1987SCM       
AP011/26/1987SLR3419011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18421s16ltr.pdf 11/26/2001
AP06/28/1988SCP       
AP011/26/1989SLR3420013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18421s16ltr.pdf 11/26/2001
AP011/26/2001SLR3421014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18421s16ltr.pdf 11/26/2001
AP011/26/2001SLR3422015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18421s16ltr.pdf 11/26/2001
AP011/26/2001SLR3423016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18421s16ltr.pdf 11/26/2001
AP06/16/1997SCM       
AP06/16/1997SCP       
AP07/29/1999SCM       
AP08/6/1999SCP       
AP01/31/2003SLR4763021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17812slr023,18421slr021ltr.pdf 1/31/2003
AP011/8/2002SCS       
AP010/25/2016SLR47507025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017812Orig1s027,018421Orig1s025,018558Orig1s021ltr.pdf 10/28/2016
AP110/25/2016SLR47507025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017812Orig1s027,018421Orig1s025,018558Orig1s021ltr.pdf 10/28/2016
AP010/20/2011SLR30404027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017812s028,018421s027ltr.pdf 10/25/2011
AP010/20/2011SLR30422027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017812s028,018421s027lbl.pdf 10/25/2011
AP07/1/2014SCM       
AP06/12/2015SCM       




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