Back to FDA Applications sponsored by SANDOZ INC

FDA Drug Application 203563 by SANDOZ INC

Application Number203563
Application Type Abbreviated New Drug Application
Sponsor ApplicantSANDOZ INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
TA02/24/2015TA42101000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203563Orig1s000TAltr.pdf 3/11/2015
TA02/24/2015TA42105000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203563Orig1s000ltr.pdf 3/11/2015
TA02/24/2015TA42129000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203563Orig1s000lbl.pdf 3/12/2015
AP13/9/2015N42101000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203563Orig1s000TAltr.pdf 3/11/2015
AP13/9/2015N42105000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203563Orig1s000ltr.pdf 3/11/2015
AP13/9/2015N42129000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203563Orig1s000lbl.pdf 3/12/2015




Back to FDA Applications sponsored by SANDOZ INC