Back to FDA Applications sponsored by SUN PHARMA GLOBAL

FDA Drug Application 205583 by SUN PHARMA GLOBAL

Application Number205583
Application Type New Drug Application
Sponsor ApplicantSUN PHARMA GLOBAL
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
AP01/28/2014N38398000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205583Orig1s000ltr.pdf 1/29/2014
AP01/28/2014N38417000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205583s000lbl.pdf 1/31/2014
AP01/28/2014N40752000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205583Orig1s000TOC.cfm 10/10/2014
AP01/28/2014N40753000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205583Orig1s000SumR.pdf 10/10/2014
AP07/18/2014SLR39953001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205583s001s003lbl.pdf 7/23/2014
AP07/18/2014SLR39941001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205583Orig1s001,s003ltr.pdf 7/23/2014
AP07/18/2014SLR39942003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205583Orig1s001,s003ltr.pdf 7/23/2014
AP07/18/2014SLR39954003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205583s001s003lbl.pdf 7/23/2014
AP02/3/2015SCM       




Back to FDA Applications sponsored by SUN PHARMA GLOBAL