Back to FDA Applications sponsored by ANI PHARMS

FDA Drug Application 008306 by ANI PHARMS

Application Number008306
Application Type New Drug Application
Sponsor ApplicantANI PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/21/1952N       
AP04/2/1984SCF       
AP04/2/1984SES       
AP04/12/1984SPD       
AP05/29/1986SCS       
AP04/13/1987SCS       
AP07/29/1985SCS       
AP011/4/1985SLR       
AP06/30/1988SCS       
AP01/11/1989SLR       
AP012/12/1989SCM       
AP012/12/1989SCM       
AP03/30/1992SCM       
AP02/10/1998SCS       
AP05/6/1998SCM       
AP06/23/2000SCS       
AP02/23/2001SLR17066029   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/008306_S029_PHENERGA-CODEINE_AP.pdf 7/6/2007
AP011/26/2008SLR21293030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/008306s030ltr.pdf 11/28/2008
AP011/26/2008SLR21495030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/008306s030lbl.pdf 1/2/2009
AP05/9/2013SLR36038031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/008306Orig1s031ltr.pdf 5/13/2013
AP05/9/2013SLR36056031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/008306s031lbl.pdf 5/14/2013




Back to FDA Applications sponsored by ANI PHARMS

Problems, Comments, Suggestions? Click here to contact Greg Thatcher

Please read my Disclaimer





Copyright (c) 2013 Thatcher Development Software, LLC. All rights reserved. No claim to original U.S. Gov't works.