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FDA Drug Application 018938 by FERRING PHARMS INC

Application Number018938
Application Type New Drug Application
Sponsor ApplicantFERRING PHARMS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/30/1984N18617000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107924.htm 12/4/2007
AP012/20/1984SLR       
AP011/7/1985SLR       
AP05/25/1988SCM       
AP07/1/1988SCS       
AP04/3/1990SLR       
AP01/3/1991SCS       
AP04/22/1992SCM       
AP05/12/1993SLR       
AP01/11/1994SLR       
AP03/13/1995SLR       
AP04/25/1995SCS       
AP08/17/1998SLR       
AP09/24/1999SCS       
AP01/13/2000SCM       
AP010/31/2000SCS       
AP08/8/2002SLR1650017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18938slr017ltr.pdf 8/8/2002
AP08/8/2002SLR17155017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/018938_S017_DDAVP_AP.pdf 7/9/2007
AP011/12/2003SLR6944019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17922slr031,18938slr019,19955slr005ltr.pdf 11/25/2003
AP011/10/2005SLR13049023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017922s034,018938s023,019955s010ltr.pdf 11/16/2005
AP011/10/2005SLR13072023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017922s034,018938s023,019955s010ltr.pdf 11/17/2005
AP010/26/2007SLR18319027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017922s038,018938s027,019955s013lbl.pdf 11/7/2007
AP010/26/2007SLR18394027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017922s038, 018938s027, 019955s013ltr.pdf 11/8/2007
AP011/5/2015SLR44431029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017922Orig1s042,018938Orig1s029ltr.pdf 11/9/2015
AP011/5/2015SLR44543029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017922s042,018938s029lbl.pdf 11/19/2015
AP011/13/2013SCM       
AP02/28/2014SCM       
AP06/10/2014SCM       
AP04/22/2015SCM       
AP012/18/2015SCM       




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