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FDA Drug Application 018461 by BAXTER HLTHCARE

Application Number018461
Application Type New Drug Application
Sponsor ApplicantBAXTER HLTHCARE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/22/1981N       
AP07/22/1981SCS       
AP07/27/1981SLR       
AP012/21/1981SCS       
AP04/16/1982SCS       
AP010/1/1981SCS       
AP010/1/1981SLR       
AP06/3/1982SCS       
AP02/22/1982SCS       
AP02/22/1982SLR       
AP011/20/1981SCS       
AP05/25/1982SLR       
AP03/16/1984SCS       
AP01/24/1985SCS       
AP03/14/1983SCS       
AP06/11/1985SCS       
AP04/30/1984SLR       
AP02/28/1984SCS       
AP09/4/1986SPF       
AP010/23/1984SCS       
AP06/13/1985SCS       
AP09/13/1985SLR       
AP04/15/1985SCS       
AP02/27/1986SCP       
AP05/28/1987SCS       
AP07/25/1987SCP       
AP01/12/1989SCS       
AP07/26/1989SCS       
AP02/15/1991SCS       
AP03/26/1991SCS       
AP05/24/1990SCS       
AP04/29/1991SCS       
AP04/3/1991SCS       
AP01/8/1993SLR       
AP03/16/1994SCS       
AP09/29/1994SCS       
AP09/18/1998SLR       
AP06/3/1999SCM       
AP011/23/1999SCP       
AP01/23/2002SLR3399050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18461s50ltr.pdf 1/23/2002
AP01/23/2002SLR3400050   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-461S050_Lidocaine.pdf 1/23/2002
AP01/23/2002SLR3401050   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-461S050_Lidocaine.pdf 9/10/2002
AP012/11/2003SLR7251052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18461slr052ltr.pdf 12/16/2003
AP02/27/2012SLR31971055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018461s055ltr.pdf 2/29/2012
AP03/5/2012SLR32057056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018461s056lbl.pdf 3/5/2012
AP03/5/2012SLR32081056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018461s056ltr.pdf 3/12/2012
AP04/7/2015SCM       




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