Back to FDA Applications sponsored by HERITAGE PHARMS INC

FDA Drug Application 016949 by HERITAGE PHARMS INC

Application Number016949
Application Type New Drug Application
Sponsor ApplicantHERITAGE PHARMS INC
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
AP012/23/1977N16514000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273 5/9/2007
AP012/23/1977N24008000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088622.pdf 11/19/2009
AP09/9/1980SCP       
AP09/9/1980SCS       
AP09/9/1980SCS       
AP04/17/1978SCF       
AP07/24/1978SCM       
AP08/22/1978SCP       
AP09/7/1979SCM       
AP09/25/1978SLR       
AP08/15/1979SCM       
AP01/21/1980SCF       
AP05/19/1980SCF       
AP03/28/1980SLR       
AP05/19/1980SCF       
AP03/22/1982SCM       
AP09/20/1982SCS       
AP09/20/1982SCS       
AP06/26/1984SCS       
AP04/17/1985SLR       
AP011/19/1985SLR       
AP06/9/1988SCS       
AP03/28/2000SLR       
AP01/16/1990SCP       
AP012/28/1992SCS       
AP03/28/2000SLR       
AP03/28/2000SLR       
AP06/5/2001SLR3405033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16949s33ltr.pdf 6/5/2001
AP012/19/2001SCM       
AP01/12/2005SLR10968035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/16949s035ltr.pdf 1/13/2005
AP01/12/2005SLR10988035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/16949s035lbl.pdf 1/13/2005
AP08/3/2007SLR17503038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016949s038lbl.pdf 8/6/2007
AP08/3/2007SLR17571038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016949s038ltr.pdf 8/7/2007
AP04/25/2016SLR45762039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/016949Orig1s039ltr.pdf 4/27/2016
AP04/25/2016SLR45773039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016949s039lbl.pdf 4/27/2016




Back to FDA Applications sponsored by HERITAGE PHARMS 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.