Back to FDA Applications sponsored by ANI PHARMS INC

FDA Drug Application 018027 by ANI PHARMS INC

Application Number018027
Application Type New Drug Application
Sponsor ApplicantANI PHARMS 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
AP04/27/1979N       
AP09/13/1979SLR       
AP010/3/1979SCP       
AP01/4/1980SLR       
AP010/3/1979SLR       
AP010/3/1979SCP       
AP03/26/1984SCM       
AP05/13/1980SCM       
AP010/2/1980SLR       
AP04/6/1981SCM       
AP08/6/1981SCP       
AP09/25/1981SLR       
AP02/19/1982SCP       
AP04/19/1982SCM       
AP02/25/1983SCP       
AP02/25/1983SCP       
AP05/29/1985SCS       
AP03/26/1985SCM       
AP05/1/1986SCS       
AP010/7/2002SLR       
AP010/7/2002SLR       
AP04/7/1989SCP       
AP08/24/1988SCM       
AP010/13/1988SCP       
AP010/13/1988SCP       
AP04/20/1990SLR       
AP010/7/2002SLR       
AP05/2/1990SCF       
AP010/7/2002SLR3436040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18027slr040,046,049ltr.pdf 10/7/2002
AP010/7/2002SLR3439040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18027s40s46s49lbl.pdf 10/7/2002
AP05/26/1995SCS       
AP07/11/1997SCM       
AP010/7/2002SLR3440046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18027s40s46s49lbl.pdf 10/7/2002
AP010/7/2002SLR3437046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18027slr040,046,049ltr.pdf 10/7/2002
AP012/22/2000SCE       
AP010/16/2001SCE       
AP010/7/2002SLR3438049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18027slr040,046,049ltr.pdf 10/7/2002
AP010/7/2002SLR3441049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18027s40s46s49lbl.pdf 10/7/2002
AP04/7/2006SLR13903051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018027s051ltr.pdf 4/13/2006
AP010/1/2006SLR15054055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018027s055LTR.pdf 10/5/2006
AP010/1/2006SLR19591055   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/018027_s055_lithobid_LBL.pdf 4/2/2008
AP010/20/2011SLR30395056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018027s056ltr.pdf 10/24/2011
AP010/20/2011SLR30423056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018027s056lbl.pdf 10/25/2011
AP01/5/2015SCM       
AP05/11/2015SCM       
AP05/27/2016SLR46208059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018027Orig1s059ltr.pdf 6/1/2016
AP05/27/2016SLR46225059   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018027s059lbl.pdf 6/1/2016




Back to FDA Applications sponsored by ANI 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.