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FDA Drug Application 020357 by BRISTOL MYERS SQUIBB

Application Number020357
Application Type New Drug Application
Sponsor ApplicantBRISTOL MYERS SQUIBB
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
AP03/3/1995N       
AP09/13/1995SCP       
AP04/30/1996SCS       
AP07/26/1996SCM       
AP06/6/1997SCM       
AP011/6/1997SLR4287006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020357a_s006.pdf 11/6/1997
AP05/15/1998SCM       
AP02/10/1998SLR       
AP07/2/1998SCM       
AP010/22/1998SE1872010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20357s10ltr.pdf 10/22/1998
AP010/22/1998SE1873010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020357s010.cfm 10/22/1998
AP011/5/1998SCF       
AP011/18/1998SCM       
AP012/4/1998SCS       
AP06/1/1999SCM       
AP03/12/1999SCM       
AP09/22/1999SE81252017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20357S17.PDF 9/22/1999
AP06/7/1999SCS       
AP012/15/2000SE51517019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20357S19LTR.PDF 12/15/2000
AP012/15/2000SE52140019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20357s19_glucophage.cfm 12/15/2000
AP012/15/2000SE54727019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20357S019_Glucophage_prntlbl.pdf 2/15/2000
AP04/19/2001SE85019020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20357S20ltr.pdf 4/23/2001
AP04/19/2001SE816214020   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020357_S020_GLUCOPHAGE_AP.pdf 4/11/2007
AP08/4/2000SCM       
AP02/8/2001SLR       
AP01/8/2002SLR2147024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21202s3ltr.pdf 1/8/2002
AP03/19/2004SLR8012026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20357slr026,027,21202slr011,013ltr.pdf 3/24/2004
AP03/19/2004SLR8013027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20357slr026,027,21202slr011,013ltr.pdf 3/24/2004
AP011/1/2006SLR15296030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020357s030,021202s015lbl.pdf 11/6/2006
AP011/1/2006SLR15312030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020357s030,021202s015ltr.pdf 11/6/2006
AP08/27/2008SLR20696031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020357s031, 021202s016ltr.pdf 8/28/2008
AP08/27/2008SLR20699031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020357s031,021202s016lbl.pdf 8/29/2008
AP03/14/2013SCM       
AP011/13/2013SCM       




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