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FDA Drug Application 016320 by STI PHARMA LLC

Application Number016320
Application Type New Drug Application
Sponsor ApplicantSTI PHARMA LLC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/6/1967N       
AP02/21/1975SCS       
AP04/28/1976SCS       
AP06/10/1976SCS       
AP05/13/1977SCS       
AP07/5/1977SCF       
AP04/7/1978SCS       
AP05/3/1978SCM       
AP06/27/1978SCS       
AP06/26/1978SCS       
AP012/21/1978SLR       
AP04/3/1979SCM       
AP04/3/1979SCS       
AP01/9/1981SCM       
AP07/29/1981SCS       
AP08/18/1981SCS       
AP08/18/1981SCE       
AP011/3/1981SCM       
AP02/24/1982SCS       
AP06/25/1987SLR       
AP09/12/1985SCS       
AP01/3/1986SCS       
AP05/19/1987SCF       
AP011/23/1987SCS       
AP011/2/1987SCE       
AP06/20/1995SCS       
AP05/8/1998SCP       
AP05/14/1998SCS       
AP010/10/2001SLR5900056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/16320s56lbl.pdf 6/10/2003
AP02/6/2003SLR4778057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16320slr057,058ltr.pdf 2/6/2003
AP02/6/2003SLR4781057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/16320slr057_Myambutol_lbl.pdf 2/6/2003
AP02/6/2003SLR4779058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16320slr057,058ltr.pdf 2/6/2003
AP02/6/2003SLR4780058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/16320slr057_Myambutol_lbl.pdf 2/6/2003
AP03/24/2004SLR8125060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16320slr060ltr.pdf 3/28/2004
AP03/24/2004SLR8289060   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16320slr060_myambutol_lbl.pdf 4/5/2004
AP010/30/2008SCP21119063   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/016320s063ltr.pdf 11/3/2008
AP010/30/2008SCP21145063   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016320s063lbl.pdf 11/7/2008
AP02/22/2013SCM35255066   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016320s066lbl.pdf 2/26/2013




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