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FDA Drug Application 008381 by ANI PHARMS

Application Number008381
Application Type New Drug Application
Sponsor ApplicantANI PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New ester, new salt, or other noncovalent derivative
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/11/1952N       
AP04/18/1984SPD       
AP04/18/1984SCF       
AP04/18/1984SE1       
AP05/29/1986SCS       
AP07/27/1985SCS       
AP011/4/1985SLR       
AP09/8/1986SLR       
AP03/2/1987SLR       
AP04/6/1988SLR       
AP06/30/1988SCS       
AP012/13/1989SCM       
AP012/12/1989SCM       
AP02/6/1992SCS       
AP03/30/1992SCM       
AP05/6/1998SCM       
AP06/27/2003S6029026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/08381slr027ltr.pdf 7/6/2003
AP06/27/2003SLR6028027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/08381slr027ltr.pdf 7/6/2003
AP04/2/2008SCM19630028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/08381s028,11265s029ltr.pdf 4/9/2008
AP04/2/2008SCM19660028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/008381s028,011265s029lbl.pdf 4/16/2008
AP011/10/2008SLR21206030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/008381s030lbl.pdf 11/12/2008
AP011/10/2008SLR21219030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/008381s030ltr.pdf 11/13/2008




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