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FDA Drug Application 017854 by ANI PHARMS

Application Number017854
Application Type New Drug Application
Sponsor ApplicantANI PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/30/1980N31080000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM235574.pdf 12/20/2011
AP05/13/1981SCP       
AP06/28/1982SES       
AP05/13/1981SCM       
AP05/13/1981SCS       
AP08/15/1984SES       
AP011/6/1981SCP       
AP02/18/1982SCP       
AP012/9/1981SCM       
AP02/19/1982SCM       
AP02/25/1982SCS       
AP09/23/1982SCS       
AP07/27/1983SCF       
AP09/8/1982SLR       
AP011/12/1982SLR       
AP04/13/1983SLR       
AP05/11/1983SCS       
AP07/5/1983SLR       
AP05/1/1984SCP       
AP05/1/1984SLR       
AP09/21/1984SCS       
AP03/12/1985SLR       
AP01/18/1985SCP       
AP08/20/1985SLR       
AP010/21/1985SLR       
AP01/16/1986SCS       
AP04/23/1986SLR       
AP04/15/1986SCP       
AP05/5/1987SCF       
AP010/21/1986SLR       
AP09/12/1988SCM       
AP08/31/1992SCS       
AP02/22/1989SLR       
AP05/31/1994SLR       
AP06/24/1996SLR       
AP06/1/2000SLR       
AP02/3/1998SCM       
AP03/9/1999SLR3126039   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18821-S018_Reglan.pdf 6/18/2001
AP04/22/2003SLR5719040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17854slr040ltr.pdf 5/29/2003
AP011/7/2001SLR3123041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17854s41ltr.pdf 11/25/2002
AP04/22/2003SLR5718044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17854slr044ltr.pdf 5/29/2003
AP04/22/2003SLR5720045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17854slr045ltr.pdf 5/29/2003
AP07/26/2004SLR9864047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17854s047ltr.pdf 7/28/2004
AP07/26/2004SLR9869047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17854s047lbl.pdf 7/28/2004
AP06/30/2009SLR22867051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017854s051,021793s004ltr.pdf 7/6/2009
AP06/30/2009SLR23445051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017854s051,021793s004lbl.pdf 9/22/2009
AP06/30/2009SLR27422051   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/017854_s051_reglan_tablets.pdf 1/4/2011
AP09/4/2009SLR23555052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017854s052lbl.pdf 10/8/2009
AP09/4/2009SLR23680052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017854s052_021793s005ltr.pdf 10/26/2009
AP09/4/2009SLR23431052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017854s052mg.pdf 9/21/2009
AP011/18/2010SLR27002055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017854s055,021793s008ltr.pdf 11/22/2010
AP011/18/2010SLR27021055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017854s055lbl.pdf 11/26/2010
AP011/18/2010SLR27022055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017854s055MedG.pdf 11/26/2010
AP08/2/2011SLR29680056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017854s056ltr.pdf 8/5/2011
AP09/22/2011SLR30068058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017854s058lbl.pdf 9/23/2011
AP09/22/2011SLR30079058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017854s058ltr.pdf 9/26/2011
AP01/12/2015SCM       
AP04/17/2015SCM       
AP06/15/2015SCM       




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