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FDA Drug Application 205613 by VALEANT PHARMS INTL

Application Number205613
Application Type New Drug Application
Sponsor ApplicantVALEANT PHARMS INTL
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
TA09/15/2014TA40505000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205613Orig1s000TAltr.pdf 9/17/2014
AP110/7/2014N40505000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205613Orig1s000TAltr.pdf 9/17/2014
TA09/15/2014TA40732000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205613Orig1s000ltr.pdf 10/8/2014
AP110/7/2014N40732000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205613Orig1s000ltr.pdf 10/8/2014
TA09/15/2014TA40739000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205613s000lbl.pdf 10/9/2014
AP110/7/2014N40739000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205613s000lbl.pdf 10/9/2014
TA09/15/2014TA43214000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205613Orig1s000TOC.cfm 7/2/2015
AP110/7/2014N43214000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205613Orig1s000TOC.cfm 7/2/2015
TA09/15/2014TA43216000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205613Orig1s000SumR.pdf 7/2/2015
AP110/7/2014N43216000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205613Orig1s000SumR.pdf 7/2/2015
AP011/13/2015SCM       




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