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FDA Drug Application 022534 by SUN PHARMA GLOBAL

Application Number022534
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
TA02/23/2010TA25092000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022534s000TAltr.pdf 3/22/2010
TA02/23/2010TA28702000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022534s000ltr.pdf 5/5/2011
TA02/23/2010TA28906000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022534s000lbl.pdf 5/24/2011
TA02/23/2010TA31726000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022534_docefrez_toc.cfm 2/10/2012
TA02/23/2010TA31727000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022534Orig1s000SumR.pdf 2/10/2012
AP15/3/2011N25092000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022534s000TAltr.pdf 3/22/2010
AP15/3/2011N28702000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022534s000ltr.pdf 5/5/2011
AP15/3/2011N28906000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022534s000lbl.pdf 5/24/2011
AP15/3/2011N31726000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022534_docefrez_toc.cfm 2/10/2012
AP15/3/2011N31727000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022534Orig1s000SumR.pdf 2/10/2012
AP07/20/2012SLR33252002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022534Orig1s002ltr.pdf 7/20/2012
AP07/20/2012SLR33276002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022534s002lbl.pdf 7/25/2012
AP06/21/2013SCM       
AP010/30/2014SLR40909004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022534Orig1s004ltr.pdf 10/31/2014
AP010/30/2014SLR40939004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022534s004lbl.pdf 11/4/2014
AP02/3/2015SCM       
AP05/5/2015SCM       




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