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FDA Drug Application 018657 by BAXTER HLTHCARE

Application Number018657
Application Type New Drug Application
Sponsor ApplicantBAXTER HLTHCARE
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
AP012/24/1981N       
AP06/30/1982SLR       
AP012/20/1984SLR       
AP08/8/1984SCM       
AP08/21/1987SLR       
AP011/13/1984SCS       
AP02/17/1988SLR       
AP02/17/1988SE5       
AP04/24/1986SCS       
AP02/17/1988SLR       
AP08/26/1986SLR       
AP012/28/1987SLR       
AP04/13/1989SLR       
AP07/2/1991SCS       
AP09/25/1991SCE       
AP011/8/1991SCS       
AP04/2/1993SCS       
AP05/15/1992SCP       
AP08/9/1993SCM       
AP09/21/1994SCS       
AP02/28/1995SCS       
AP04/16/1996SCS       
AP05/13/1997SCP       
AP01/30/1998SCM       
AP06/2/2004SLR9106026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18657slr026,027ltr.pdf 6/7/2004
AP06/2/2004SLR9116026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18657slr026,027_metronidazole_lbl.pdf 6/7/2004
AP06/2/2004SLR9107027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18657slr026,027ltr.pdf 6/7/2004
AP06/2/2004SLR9118027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18657slr026,027_metronidazole_lbl.pdf 6/7/2004
AP05/25/2012SLR32778028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018657s028ltr.pdf 5/30/2012
AP08/6/2009SLR23373029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018657s029lbl.pdf 9/17/2009
AP08/6/2009SLR23962029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018657s029ltr.pdf 11/19/2009
AP08/5/2011SLR29725031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018657s031ltr.pdf 8/9/2011
AP08/5/2011SLR29770031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018657s031lbl.pdf 8/12/2011
AP010/24/2013SLR37565032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018657Orig1s032ltr.pdf 10/25/2013
AP010/24/2013SLR37581032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018657s032lbl.pdf 10/25/2013
AP07/13/2015SLR43365034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018657Orig1s034ltr.pdf 7/14/2015
AP07/13/2015SLR43384034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018657s034lbl.pdf 7/16/2015
AP01/13/2016SCM       




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