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FDA Drug Application 019858 by BAYER PHARMS

Application Number019858
Application Type New Drug Application
Sponsor ApplicantBAYER PHARMS
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
AP012/26/1990N       
AP04/24/1991SCP       
AP04/24/1991SCP       
AP05/13/1992SCS       
AP04/23/1992SCS       
AP010/25/1995SLR       
AP010/21/1996SE1       
AP010/10/1996SE1       
AP09/26/1997SLR20561011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019858_S011_CIPRO.pdf 8/11/2008
AP04/3/1998SE5       
AP07/9/1996SCP       
AP08/9/1996SLR       
AP08/7/1997SE1       
AP09/24/1998SE1       
AP09/24/1998SLR       
AP09/24/1998SE1       
AP09/24/1998SLR       
AP06/28/2000SLR       
AP08/30/2000SE12440021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20780S08ltr.pdf 8/30/2000
AP08/30/2000SE12441021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20780S08lbl.pdf 8/30/2000
AP08/30/2000SE12442021   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19-537S038_Cipro.cfm 8/30/2000
AP04/17/2002SLR2431022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19847s26ltr.pdf 4/17/2002
AP04/17/2002SLR2432022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19847s26lbl.pdf 4/17/2002
AP04/17/2002SLR20446022   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019858_S022_CIPRO.pdf 8/4/2008




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