Back to FDA Applications sponsored by BAXTER HLTHCARE

FDA Drug Application 019615 by BAXTER HLTHCARE

Application Number019615
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
AP03/27/1987N       
AP011/15/1988SCS       
AP07/28/1989SCS       
AP012/7/1989SCS       
AP011/9/1990SCS       
AP012/2/1991SCM       
AP02/7/1994SCS       
AP09/29/1994SCS       
AP08/30/1995SLR       
AP02/7/1996SLR       
AP03/27/1998SLR       
AP04/17/2001SE51349012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19615S12ltr.pdf 4/17/2001
AP04/17/2001SE51740012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19615S012_Dopamine.pdf 4/17/2001
AP011/23/1999SCP       
AP06/19/2007SLR16917014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019615s014ltr.pdf 7/5/2007
AP08/22/2001SCS       
AP06/20/2002SLR1739017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19615s017LTR.pdf 6/20/2002
AP03/13/2012SLR32109020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019615s020ltr.pdf 3/15/2012
AP06/15/2012SLR32921021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019615s021ltr.pdf 6/18/2012
AP06/15/2012SLR32924021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019615s021lbl.pdf 6/18/2012
AP05/21/2013SCM       




Back to FDA Applications sponsored by BAXTER HLTHCARE