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FDA Drug Application 018553 by ANI PHARMS INC

Application Number018553
Application Type New Drug Application
Sponsor ApplicantANI PHARMS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/19/1983N       
AP01/9/1984SES       
AP03/6/1984SCM       
AP010/11/1984SCS       
AP08/9/1984SCE23312005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018553_s005_INDERAL LA.pdf 9/14/2009
AP03/21/1985SLR23313006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018553_s006_INDERAL LA.pdf 9/14/2009
AP08/20/1985SES       
AP01/7/1986SCS       
AP04/2/1985SCM       
AP011/20/1985SCS       
AP03/4/1986SCM23314012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018553_s012_INDERAL LA.pdf 9/14/2009
AP03/18/1987SE223315013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018553_s013_INDERAL LA.pdf 9/14/2009
AP05/27/1986SCF23316015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018553_s015_INDERAL LA.pdf 9/14/2009
AP09/2/1986SCS       
AP01/20/1987SCP       
AP05/25/1988SCP       
AP08/8/1988SCS       
AP01/25/1989SCP       
AP04/10/1989SCS       
AP06/5/1989SCM       
AP07/10/1989SCE       
AP02/9/1990SCF       
AP04/17/1990SCS       
AP011/7/1997SLR       
AP08/22/1999SLR       
AP03/31/2000SCM       
AP02/6/2002SLR       
AP06/9/2004SLR9312030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18553slr030ltr.pdf 6/10/2004
AP01/3/2007SLR15585034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018553s034ltr.pdf 1/8/2007
AP02/21/2007SLR15952035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018553s035ltr.pdf 3/6/2007
AP010/31/2007SLR18369036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018553s036ltr.pdf 11/8/2007
AP03/17/2011SLR28302037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018553s037lbl.pdf 3/21/2011
AP03/17/2011SLR28311037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018553s037ltr.pdf 3/23/2011
AP010/22/2015SCM       
AP012/21/2015SCM       




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