Back to FDA Applications sponsored by MALLINCKRODT LLC

FDA Drug Application 018013 by MALLINCKRODT LLC

Application Number018013
Application Type New Drug Application
Sponsor ApplicantMALLINCKRODT LLC
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
AP08/1/1977N16531000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273 5/9/2007
AP08/1/1977N24046000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088671.pdf 11/20/2009
AP06/29/1978SES       
AP02/18/1982SES       
AP06/14/1979SCM       
AP09/17/1979SCP       
AP011/20/1979SLR       
AP07/24/1981SCP       
AP06/26/1981SCM       
AP03/25/1982SCP       
AP06/2/1982SCS       
AP05/1/1984SLR       
AP012/11/1984SCP       
AP06/27/1985SCF       
AP06/11/1985SLR       
AP08/25/1986SCS       
AP01/16/1990SCP       
AP011/7/1988SCP       
AP011/7/1989SCP       
AP03/26/1990SCM       
AP03/13/1991SLR       
AP08/26/1993SLR       
AP08/2/1991SCS       
AP03/12/1992SCP       
AP01/21/1992SCM       
AP07/23/1993SCS       
AP06/10/1993SCS       
AP06/16/1993SCS       
AP06/16/1993SCS       
AP08/17/1993SCF       
AP07/23/1993SCP       
AP010/6/1993SLR       
AP04/1/1994SCP       
AP04/15/1994SCM       
AP07/7/1994SCS       
AP09/18/1995SCS       
AP012/7/1995SCM       
AP04/28/1999SCM       
AP04/15/1999SCP       
AP04/27/2000SCM       
AP07/31/2001SLR23309053   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/018013_s053_PAMELOR CAPSULES.pdf 9/14/2009
AP06/7/2001SCM       
AP012/6/2004SCM       
AP01/12/2005SLR10978056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18012s026,18013s056ltr.pdf 1/13/2005
AP01/12/2005SLR10998056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18012s026,18013s056lbl.pdf 1/13/2005
AP07/13/2007SLR17286058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018013s58lbl.pdf 7/16/2007
AP07/13/2007SLR17347058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017090s74,18012s27,18013s58,19906s34ltr.pdf 7/24/2007
AP010/26/2012SLR34183061   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018012s029,018013s061lbl.pdf 10/26/2012
AP010/26/2012SLR34198061   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019906Orig1s037,018012Orig1029,018013Orig1s061,017090Orig1s076ltr.pdf 10/29/2012
AP07/10/2014SLR39842062   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018013s062lbl.pdf 7/11/2014
AP07/10/2014SLR39854062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018012Orig1s030,018013Orig1s062,017090Orig1s077,019906Orig1s038ltr.pdf 7/11/2014
AP07/28/2014SLR40031063   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018012Orig1s031,018013Orig1s063,017090Orig1s078,019906Orig1s039ltr.pdf 7/29/2014
AP07/28/2014SLR40037063   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018013s063lbl.pdf 7/29/2014




Back to FDA Applications sponsored by MALLINCKRODT LLC