Back to FDA Applications sponsored by ACTAVIS LABS UT INC

FDA Drug Application 020232 by ACTAVIS LABS UT INC

Application Number020232
Application Type New Drug Application
Sponsor ApplicantACTAVIS LABS UT INC
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
AP07/30/1992N       
AP012/1/1992SCS       
AP03/29/1994SCP       
AP01/18/1996SLR       
AP011/8/1995SCM       
AP05/20/1998SLR       
AP04/22/1999SCP       
AP08/3/1999SCM       
AP010/4/2001SLR       
AP05/30/2001SCS       
AP05/22/2001SCM       
AP01/3/2002SCS       
AP04/26/2002SCS       
AP03/21/2008SLR19509021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020232s021lbl.pdf 3/24/2008
AP03/21/2008SLR19527021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020232s021ltr.pdf 3/24/2008
AP06/22/2011SLR29299033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020232s033ltr.pdf 6/28/2011
AP06/22/2011SLR29347033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020232s033lbl.pdf 6/29/2011
AP05/9/2013SLR36042035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020232Orig1s035ltr.pdf 5/13/2013
AP05/9/2013SLR36060035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020232s035lbl.pdf 5/14/2013
AP010/18/2013SLR37488036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020232Orig1s036ltr.pdf 10/22/2013
AP010/18/2013SLR37526036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020232s036lbl.pdf 10/22/2013
AP06/5/2014SCM       
AP06/16/2015SCM       
AP07/31/2015SCM       
AP18/11/2015SCM       




Back to FDA Applications sponsored by ACTAVIS LABS UT INC

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.