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FDA Drug Application 020756 by COLUMBIA RES LABS

Application Number020756
Application Type New Drug Application
Sponsor ApplicantCOLUMBIA RES LABS
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
AP05/13/1997N6422000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020756_crinone_toc.cfm 8/7/2003
AP012/22/1997SCS       
AP02/17/1998SCS       
AP012/11/1997SCS       
AP05/11/1998SLR       
AP012/16/1998SCE       
AP04/3/2001SLR5064009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20756S9ltr.pdf 4/11/2001
AP04/20/2001SCS5027010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20756S10ltr.pdf 4/23/2001
AP09/17/2003SLR6705012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20701slr011,20756slr012ltr.pdf 9/29/2003




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