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FDA Drug Application 009402 by PAR STERILE PRODUCTS

Application Number009402
Application Type New Drug Application
Sponsor ApplicantPAR STERILE PRODUCTS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/15/1954N       
AP09/7/1982SCS       
AP07/18/1983SCS       
AP03/19/1984SPD       
AP07/31/1985SCM       
AP06/1/1984SCS       
AP011/16/1984SLR       
AP011/26/1984SLR       
AP01/15/1985SLR       
AP05/5/1986SCS       
AP03/2/1989SLR       
AP09/11/1987SCS       
AP012/28/1987SLR       
AP03/2/1989SLR       
AP05/5/1989SCP       
AP01/12/1990SLR       
AP06/17/1998SLR       
AP012/12/2003SLR7247037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/09402slr037ltr.pdf 12/16/2003
AP012/12/2003SLR8885037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/09402slr037_delestrogen_lbl.pdf 6/2/2004
AP07/17/2002SCM       
AP012/12/2003SLR7246039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/09402slr037ltr.pdf 12/16/2003
AP012/12/2003SLR7248039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/09402slr037_delestrogen_lbl.pdf 12/16/2003
AP07/26/2004SLR9865040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/09402s040ltr.pdf 7/28/2004
AP07/26/2004SLR9868040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/09402s040lbl.pdf 7/28/2004
AP010/11/2007SCM18237041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/009402s041ltr.pdf 10/15/2007
AP08/11/2015SCM       
AP010/20/2015SCM       
AP03/10/2016SCM       




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