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FDA Drug Application 018261 by PAR STERILE PRODUCTS

Application Number018261
Application Type New Drug Application
Sponsor ApplicantPAR STERILE PRODUCTS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/19/1980N       
AP01/27/1984SCS       
AP09/19/1986SLR       
AP01/29/1987SCS       
AP02/16/1988SLR       
AP07/3/1990SLR       
AP08/9/1994SLR       
AP08/23/1994SLR       
AP05/27/1994SCS       
AP02/22/1996SLR       
AP07/29/1997SLR4320011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/18261-s011_pitocin.pdf 7/29/1997
AP07/10/1997SCS       
AP02/22/1999SLR       
AP011/10/1999SCS       
AP03/1/2000SCE       
AP03/23/2000SCP       
AP010/25/2000SCS       
AP03/8/2001SCS       
AP03/8/2001SCE       
AP03/8/2001SLR       
AP01/10/2002SLR3478021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18261s21ltr.pdf 1/10/2002
AP01/10/2002SLR19595021   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/018261_s021_PITOCIN_LBL.pdf 4/4/2008
AP09/24/2001SCS       
AP03/24/2003SLR19596023   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/018261_s023_PITOCIN_LBL.pdf 4/4/2008
AP03/24/2003SLR4507023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18261slr023ltr.pdf 3/26/2003
AP07/27/2007SCP17420028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018261s028lbl.pdf 7/30/2007
AP07/27/2007SCP17424028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018261s028ltr.pdf 7/31/2007
AP010/2/2014SLR40708031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018261Orig1s031ltr.pdf 10/3/2014
AP010/2/2014SLR40716031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018261s031lbl.pdf 10/3/2014
AP06/18/2014SCM       
AP08/15/2016SCM       
AP08/19/2016SCM       




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