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FDA Drug Application 019308 by BAXTER HLTHCARE

Application Number019308
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
AP04/5/1985N       
AP05/28/1987SCS       
AP07/25/1987SCP       
AP01/12/1989SCS       
AP07/26/1989SCS       
AP02/15/1991SCS       
AP03/26/1991SCS       
AP04/29/1991SCS       
AP012/11/1991SCS       
AP09/30/1994SCS       
AP02/18/1994SCS       
AP04/29/1997SCP       
AP011/24/1999SCM       
AP04/14/2003SLR5682017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18008slr059,18037slr059,19308slr017ltr.pdf 5/29/2003
AP08/14/2001SCM       
AP06/2/2004SLR9111020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18008slr063,18037slr063,19308slr020ltr.pdf 6/7/2004
AP08/26/2005SCP12695022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et al_lbl.pdf 8/31/2005
AP08/26/2005SCP12696022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/013684s092,016677s139,et al_ltr.pdf 8/31/2005
AP04/20/2007SLR16296023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018008s066,018037s066,019308s023lbl.pdf 4/25/2007
AP04/20/2007SLR16423023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018008s066, 018037s066, 019308s023ltr.pdf 5/1/2007
AP09/10/2013SLR37064027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018008s070,018037s070,019308s027lbl.pdf 9/11/2013
AP09/10/2013SLR37078027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018008Orig1s070,018037Orig1s070,019308Orig1s027ltr.pdf 9/12/2013




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