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FDA Drug Application 017812 by ROXANE

Application Number017812
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
AP011/26/1980N       
AP09/9/1982SLR       
AP01/6/1982SCS       
AP01/31/1983SLR       
AP06/14/1983SLR       
AP01/28/1987SCF       
AP01/28/1987SCF       
AP01/28/1987SLR       
AP09/29/1987SCM       
AP011/26/2001SLR3414011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18421s16ltr.pdf 11/26/2001
AP02/10/1988SCS       
AP011/26/2001SLR3415013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18421s16ltr.pdf 11/26/2001
AP011/26/2001SLR3416014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18421s16ltr.pdf 11/26/2001
AP08/1/1994SCP       
AP011/26/2001SLR3417016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18421s16ltr.pdf 11/26/2001
AP011/26/2001SLR3418017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18421s16ltr.pdf 11/26/2001
AP06/3/1998SCM       
AP08/17/2000SCS       
AP012/6/2000SCS       
AP06/14/2001SCP3413021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17812s21ltr.pdf 6/14/2001
AP011/21/2001SCS       
AP01/31/2003SLR4762023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17812slr023,18421slr021ltr.pdf 1/31/2003
AP010/5/2007SLR       
AP010/25/2016SLR47506027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017812Orig1s027,018421Orig1s025,018558Orig1s021ltr.pdf 10/28/2016
AP110/25/2016SLR47506027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017812Orig1s027,018421Orig1s025,018558Orig1s021ltr.pdf 10/28/2016
AP010/20/2011SLR30405028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017812s028,018421s027ltr.pdf 10/25/2011
AP010/20/2011SLR30421028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017812s028,018421s027lbl.pdf 10/25/2011
AP02/26/2016SCM       




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