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FDA Drug Application 017922 by FERRING PHARMS INC

Application Number017922
Application Type New Drug Application
Sponsor ApplicantFERRING PHARMS INC
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
AP02/21/1978N18616000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107924.htm 12/4/2007
AP02/28/1980SCM       
AP05/21/1981SCP       
AP06/8/1982SLR       
AP08/27/1982SCS       
AP03/24/1983SLR       
AP01/21/1983SLR       
AP06/1/1984SCP       
AP011/27/1984SLR       
AP011/7/1985SLR       
AP011/28/1989SE1       
AP02/6/1989SCP       
AP06/29/1988SCS       
AP05/25/1988SCM       
AP06/23/1989SCP       
AP07/19/1989SLR       
AP08/23/1990SLR       
AP04/22/1992SCM       
AP09/27/1991SLR       
AP01/26/1995SCS       
AP08/7/1996SCF       
AP01/16/1996SLR       
AP04/13/1998SLR       
AP09/24/1999SCS       
AP07/5/2000SCS       
AP010/31/2000SCS       
AP02/28/2001SCS       
AP011/12/2003SLR6940031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17922slr031,18938slr019,19955slr005ltr.pdf 11/25/2003
AP011/10/2005SLR13048034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017922s034,018938s023,019955s010ltr.pdf 11/16/2005
AP011/10/2005SLR13071034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017922s034,018938s023,019955s010ltr.pdf 11/17/2005
AP010/26/2007SLR18318038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017922s038,018938s027,019955s013lbl.pdf 11/7/2007
AP010/26/2007SLR18393038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017922s038, 018938s027, 019955s013ltr.pdf 11/8/2007
AP010/26/2007SLR       
AP011/5/2015SLR44430042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017922Orig1s042,018938Orig1s029ltr.pdf 11/9/2015
AP011/5/2015SLR44544042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017922s042,018938s029lbl.pdf 11/19/2015
AP02/28/2014SCM       
AP07/31/2015SCM       




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