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FDA Drug Application 018401 by INDIVIOR INC

Application Number018401
Application Type New Drug Application
Sponsor ApplicantINDIVIOR INC
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
AP012/29/1981N       
AP06/28/1985SLR       
AP010/19/1982SCM       
AP05/17/1985SCM       
AP02/13/1987SLR       
AP011/19/1987SLR       
AP03/9/1989SCM       
AP012/5/1989SCM       
AP04/29/1994SCS       
AP06/25/1993SLR       
AP02/13/1995SCS       
AP011/29/1995SCM       
AP02/11/2002SLR3823014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18401s014ltr.pdf 3/8/2002
AP02/11/2002SLR14078014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/018401_s014_BuprenexTOC.cfm 5/10/2006
AP06/10/2003SLR5950015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18401slr015ltr.pdf 6/22/2003
AP06/10/2003SLR15255015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/018401_S015_Buprenex Injectable_APPROVAL PACKAGE.pdf 10/26/2006
AP01/4/2013SCM       
AP02/6/2014SCM       
AP08/8/2013SCM       
AP05/11/2015SCM       




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