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FDA Drug Application 006134 by ROXANE

Application Number006134
Application Type New Drug Application
Sponsor ApplicantROXANE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/13/1947N33127000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17 http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17 7/11/2012
AP08/13/1947N33128000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM311370.pdf 7/11/2012
AP08/13/1947N23161000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm142827.htm 8/12/2009
AP01/5/1977SLR       
AP02/1/1980SCS       
AP010/16/1981SCM       
AP01/10/1986SLR       
AP08/13/1987SLR       
AP03/12/1999SLR       
AP05/11/1994SCP       
AP02/21/1995SCM       
AP010/17/2000SLR       
AP010/15/1996SCM       
AP011/12/1998SCM       
AP03/30/1999SCP       
AP05/5/2000SCS       
AP011/17/2006SLR27420028Approval Package  http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/006134_s028_dolophine_hydrochloride.pdf 11/17/2006
AP011/17/2006SLR15374028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/006134s028lbl.pdf 11/21/2006
AP011/17/2006SLR15444028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/06134s028ltr.pdf 12/4/2006
AP07/9/2012SLR33126030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/006134Orig1s030ltr.pdf 7/11/2012
AP07/9/2012SLR33140031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/006134Orig1s031ltr.pdf 7/11/2012
AP07/9/2012SLR33164031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/006134s031lbl.pdf 7/12/2012
AP04/15/2013SLR35707032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/006134Orig1s032ltr.pdf 4/16/2013
AP04/16/2014SLR39070035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/006134s035lbl.pdf 4/16/2014
AP04/16/2014SLR39073035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/006134Orig1s035ltr.pdf 4/17/2014
AP08/19/2014S40280036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/006134Orig1s036ltr.pdf 8/20/2014
AP06/26/2015S43133037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/006134Orig1s037ltr.pdf 6/29/2015
AP04/2/2015SLR42422038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/006134Orig1s038ltr.pdf 4/3/2015
AP04/2/2015SLR42454038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/006134s038lbl.pdf 4/7/2015
AP04/20/2016S45714039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/006134Orig1s039ltr.pdf 4/22/2016
AP09/30/2016S47262042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/006134Orig1s042ltr.pdf 10/4/2016




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