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FDA Drug Application 014691 by APOTEX INC

Application Number014691
Application Type New Drug Application
Sponsor ApplicantAPOTEX INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/17/1964N       
AP06/16/1980SLR       
AP06/16/1980SLR       
AP03/24/1982SCF       
AP07/19/1984SPD       
AP09/19/1984SCS       
AP09/22/1986SLR       
AP04/9/1987SLR       
AP03/26/1990SCS       
AP09/26/1989SLR       
AP08/25/1994SLR       
AP07/22/1998SCS       
AP07/14/1999SCS       
AP05/24/2001SCS3461020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/14691s20ltr.pdf 5/24/2001
AP05/24/2001SCS6018020   http://www.accessdata.fda.gov/drugsatfda_docs/NDA/2001/14-691S20_Alkeran.cfm 7/5/2003
AP010/9/2001SCM       
AP010/9/2001SCS       
AP01/7/2002SLR3459023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/14691s23ltr.pdf 1/7/2002
AP05/14/2003SLR5655024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/14691slr024_alkeran_lbl.pdf 5/28/2003
AP05/14/2003SLR5786024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/14691slr024ltr.pdf 6/8/2003
AP06/9/2005SLR11798028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/014691s028ltr.pdf 6/14/2005
AP06/9/2011SLR29122029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/014691s029,020207s016ltr.pdf 6/14/2011
AP06/9/2011SLR29127029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/014691s029lbl.pdf 6/14/2011
AP05/2/2011SLR28682030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/014691s030lbl.pdf 5/2/2011
AP05/2/2011SLR28688030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/014691s030ltr.pdf 5/4/2011




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