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FDA Drug Application 205636 by TEVA BRANDED PHARM

Application Number205636
Application Type New Drug Application
Sponsor ApplicantTEVA BRANDED PHARM
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
TA03/5/2015TA42071000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205636Orig1s000TAltr.pdf 3/10/2015
AP13/31/2015N42071000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205636Orig1s000TAltr.pdf 3/10/2015
TA03/5/2015TA42406000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205636Orig1s000ltr.pdf 4/3/2015
AP13/31/2015N42406000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205636Orig1s000ltr.pdf 4/3/2015
TA03/5/2015TA42684000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205636s000lbl.pdf 4/28/2015
AP13/31/2015N42684000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205636s000lbl.pdf 4/28/2015
TA03/5/2015TA45315000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205636Orig1s000TOC.cfm 3/2/2016
AP13/31/2015N45315000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205636Orig1s000TOC.cfm 3/2/2016
TA03/5/2015TA45316000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205636Orig1s000SumR.pdf 3/2/2016
AP13/31/2015N45316000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205636Orig1s000SumR.pdf 3/2/2016
AP07/30/2015SCM       
AP07/30/2015SCM       
AP012/11/2015SCM       
AP04/28/2016SE845809004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205636s004lbl.pdf 4/29/2016
AP04/28/2016SE845815004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205636Orig1s004ltr.pdf 5/2/2016
AP05/11/2016SCM       
AP09/8/2016SLR47017006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205636s006lbl.pdf 9/9/2016
AP09/8/2016SLR47026006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205636Orig1s006ltr.pdf 9/12/2016
AP09/7/2016SCM       
AP09/7/2016SCM       
AP010/17/2016SCM       
AP09/27/2016SCM       




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