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FDA Drug Application 012223 by TELIGENT PHARMA INC

Application Number012223
Application Type New Drug Application
Sponsor ApplicantTELIGENT PHARMA INC
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
AP06/28/1960N       
AP09/1/1976SCS       
AP09/18/1979SCS       
AP011/28/1980SCS       
AP011/3/1981SCM       
AP07/14/1981SCP       
AP08/19/1986SPD       
AP08/18/1982SLR       
AP010/11/1984SCP       
AP08/27/1985SCP       
AP04/26/1990SLR       
AP06/28/1991SLR       
AP04/24/1995SLR       
AP06/8/1995SCP       
AP012/5/1995SCM       
AP06/25/1996SCM       
AP012/6/1996SCS       
AP012/6/1996SCS       
AP01/14/1997SCS       
AP05/28/1998SCS       
AP07/14/1998SCS       
AP05/18/2001SLR4458036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12223S36ltr.pdf 5/18/2001
AP08/16/2001SCS       
AP02/27/2003SLR4234038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/12223slr038ltr.pdf 3/10/2003
AP06/4/2003SLR5785039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/12223slr039ltr.pdf 6/8/2003
AP06/4/2003SLR43782039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/012223Orig1s039Lbl.pdf 9/3/2015




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