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FDA Drug Application 020207 by APOTEX INC

Application Number020207
Application Type New Drug Application
Sponsor ApplicantAPOTEX INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/18/1992N       
AP01/5/1994SLR       
AP03/3/2000SCM       
AP010/9/2001SCM       
AP010/9/2001SCS       
AP01/7/2002SLR3460005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/14691s23ltr.pdf 1/7/2002
AP04/29/2003SLR5736007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20207slr007ltr.pdf 5/29/2003
AP04/29/2003SLR7684007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20207slr007_alkeran_lbl.pdf 2/6/2004
AP06/14/2005SLR11819012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020207s012ltr.pdf 6/15/2005
AP06/9/2011SLR29124016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/014691s029,020207s016ltr.pdf 6/14/2011
AP06/9/2011SLR29128016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020207s016lbl.pdf 6/14/2011
AP05/2/2011SLR28686017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020207s017lbl.pdf 5/2/2011
AP05/2/2011SLR28691017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020207s017ltr.pdf 5/4/2011




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