Back to FDA Applications sponsored by MALLINCKRODT ARD

FDA Drug Application 008372 by MALLINCKRODT ARD

Application Number008372
Application Type New Drug Application
Sponsor ApplicantMALLINCKRODT ARD
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
AP04/29/1952N       
AP06/1/1977SLR       
AP010/5/1977SLR       
AP03/14/1978SLR       
AP06/26/1979SLR       
AP06/26/1979SDS       
AP06/26/1979SLR       
AP06/26/1979SCE       
AP03/26/1981SLR       
AP08/24/1983SLR       
AP08/29/1984SCE       
AP01/15/1985SCE       
AP03/25/1985SCM       
AP04/22/1992SLR       
AP03/26/1993SCP       
AP04/5/1994SCP       
AP012/15/1998SCP       
AP07/15/1999SCM       
AP011/6/2002SCE       
AP03/24/2015SLR42269044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/008372Orig1s044ltr.pdf 3/25/2015
AP03/24/2015SLR42760044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/008372s044lbl.pdf 5/8/2015
AP07/5/2012SLR33090045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/008372s045ltr.pdf 7/9/2012
AP01/17/2014SCM       
AP03/4/2016SCM       
AP03/11/2016SCM       
AP03/14/2016SCM       
AP04/19/2016SCM       




Back to FDA Applications sponsored by MALLINCKRODT ARD