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FDA Drug Application 020183 by BAXTER HLTHCARE

Application Number020183
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
AP012/4/1992N       
AP09/30/1994SCS       
AP02/18/1994SCS       
AP06/1/1994SCS       
AP011/22/1996SCP       
AP04/29/1997SCP       
AP08/22/2001SCS       
AP02/12/2002SCP       
AP08/9/2005SLR12579011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017512s104,106,020163s012,013,020183s011,012ltr.pdf 8/11/2005
AP08/9/2005SCP12580012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017512s104,106,020163s012,013,020183s011,012ltr.pdf 8/11/2005
AP08/8/2006S18552015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020183_S015_VIDEX.pdf 11/19/2007
AP04/19/2013SLR35783019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017512s113,020163s020,020183s019lbl.pdf 4/23/2013
AP04/19/2013SLR35837019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017512Orig1s113,020163Orig1s020,020183Orig1s019ltr.pdf 4/24/2013
AP04/26/2013SCM       
AP09/30/2014SCM       
AP02/9/2015SLR41813024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017512Orig1s118,020163Orig1s025,020183Orig1s024ltr.pdf 2/10/2015
AP02/9/2015SLR41815024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020183s024lbl.pdf 2/10/2015
AP09/1/2015SLR43799026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017512Orig1s122,020163Orig1s027,020183Orig1s026ltr.pdf 9/4/2015
AP09/1/2015SLR43812026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017512s122,020163s027,020183s026lbl.pdf 9/4/2015
AP08/16/2016SLR46783027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017512s123,020163s028,020183s027lbl.pdf 8/17/2016
AP08/16/2016SLR46803027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017512Orig1s123,020163Orig1s028,020183Orig1s027ltr.pdf 8/18/2016




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