Back to FDA Applications sponsored by APOTEX INC

FDA Drug Application 022312 by APOTEX INC

Application Number022312
Application Type New Drug Application
Sponsor ApplicantAPOTEX INC
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
AP01/11/2012N31386000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022312s000lbl.pdf 1/12/2012
AP01/11/2012N31388000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022312s000ltr.pdf 1/17/2012
AP01/11/2012N36142000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022312_docetaxel_toc.cfm 5/24/2013
AP01/11/2012N36143000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022312Orig1s000SumR.pdf 5/24/2013




Back to FDA Applications sponsored by APOTEX INC