Back to FDA Applications sponsored by DEPOMED INC

FDA Drug Application 022544 by DEPOMED INC

Application Number022544
Application Type New Drug Application
Sponsor ApplicantDEPOMED INC
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
AP01/28/2011N30340000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022544_gralise_toc.cfm 10/18/2011
AP01/28/2011N30341000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022544Orig1s000SumR.pdf 10/18/2011
AP01/28/2011N27695000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022544s000ltr.pdf 2/3/2011
AP01/28/2011N27728000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022544s000lbl.pdf 2/4/2011
AP01/28/2011N28000000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM245196.pdf 3/1/2011
AP06/28/2011SLR29372002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022544s002lbl.pdf 6/30/2011
AP06/28/2011SLR29394002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022544s002ltr.pdf 7/5/2011
AP04/28/2011SLR28680003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022544s003ltr.pdf 5/3/2011
AP01/31/2012SLR31629006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022544s006lbl.pdf 2/1/2012
AP01/31/2012SLR31648006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022544s006ltr.pdf 2/3/2012
AP08/8/2012SLR33417008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022544s008lbl.pdf 8/9/2012
AP08/8/2012SLR33418008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022544s008mg.pdf 8/9/2012
AP08/8/2012SLR33422008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022544Orig1s008ltr.pdf 8/10/2012
AP011/30/2012SCM       
AP03/27/2013SCM35601012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022544s012lbl.pdf 4/1/2013
AP01/31/2013SCM       
AP03/25/2013SCM       
AP02/13/2013SCM       
AP03/28/2013SCM       
AP04/9/2013SCM       
AP07/31/2013SCM       
AP06/10/2013SCM       
AP09/9/2013SCM       




Back to FDA Applications sponsored by DEPOMED INC