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FDA Drug Application 011265 by ANI PHARMS

Application Number011265
Application Type New Drug Application
Sponsor ApplicantANI PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/3/1957N       
AP04/2/1984SCF       
AP04/2/1984SES       
AP04/11/1984SPD       
AP05/29/1986SCS       
AP07/31/1985SCS       
AP09/16/1985SLR       
AP08/11/1988SE6       
AP06/30/1988SCS       
AP011/16/1989SCM       
AP03/30/1992SCM       
AP02/27/1996SLR       
AP05/6/1998SCM       
AP02/23/2001SLR17065027   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/011265_S027_PHERGAN_AP.pdf 7/6/2007
AP01/16/2004SLR7576028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/11265slr028ltr.pdf 1/22/2004
AP04/2/2008SCM19631029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/08381s028,11265s029ltr.pdf 4/9/2008
AP04/2/2008SCM19661029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/008381s028,011265s029lbl.pdf 4/16/2008
AP09/16/2009SLR23752031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/011265s031ltr.pdf 11/9/2009




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