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FDA Drug Application 050588 by TELIGENT PHARMA INC

Application Number050588
Application Type New Drug Application
Sponsor ApplicantTELIGENT PHARMA INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/27/1985N       
AP011/25/1991SE2       
AP011/25/1991SLR       
AP011/25/1991SLR       
AP011/25/1991SLR       
AP05/18/1992SLR       
AP09/29/1992SLR       
AP07/30/1993SLR       
AP09/12/1995SLR       
AP07/30/1993SLR       
AP09/15/1994SCS       
AP010/20/1995SLR       
AP08/5/1999SLR       
AP03/4/2003SLR4233027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50588slr027ltr.pdf 3/10/2003
AP03/4/2003SLR8810027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50588slr027_cefotan_lbl.pdf 5/28/2004
AP06/20/2003SLR6065029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50588slr029ltr.pdf 7/6/2003
AP06/20/2003SLR6073029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50588slr029_cefotan_lbl.pdf 7/8/2003
AP06/25/2004SLR9693030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50588slr030ltr.pdf 7/1/2004
AP06/25/2004SLR9697030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50588slr030_cefotan_lbl.pdf 7/1/2004
AP012/9/2015SCM       




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