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FDA Drug Application 015197 by CLOVER PHARMS

Application Number015197
Application Type New Drug Application
Sponsor ApplicantCLOVER PHARMS
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
AP06/3/1964N       
AP02/9/1977SCF       
AP06/30/1981SCF       
AP010/22/1982SCS       
AP04/3/1990SLR       
AP09/22/1982SCP       
AP012/10/1982SLR       
AP06/6/1983SLR       
AP01/17/1986SLR       
AP08/13/1992SCE       
AP02/11/1992SCP       
AP04/16/1997SLR       
AP010/1/1999SCS       
AP010/2/2000SCS       
AP04/3/2000SLR       
AP011/27/2000SCM       
AP06/24/2004SCM9549036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/15197scm036,scf037,scp038,scm039ltr.pdf 6/25/2004
AP06/24/2004SCM9559036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/15197scm036,scf037,scp038,scm039_amicar_lbl.pdf 6/25/2004
AP06/24/2004SCF9560037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/15197scm036,scf037,scp038,scm039_amicar_lbl.pdf 6/25/2004
AP06/24/2004SCF9550037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/15197scm036,scf037,scp038,scm039ltr.pdf 6/25/2004
AP06/24/2004SCP9551038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/15197scm036,scf037,scp038,scm039ltr.pdf 6/25/2004
AP06/24/2004SCP9561038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/15197scm036,scf037,scp038,scm039_amicar_lbl.pdf 6/25/2004
AP06/24/2004SCM9562039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/15197scm036,scf037,scp038,scm039_amicar_lbl.pdf 6/25/2004
AP06/24/2004SCM9552039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/15197scm036,scf037,scp038,scm039ltr.pdf 6/25/2004
AP08/24/2004SLR10063040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/15197s040,15229s031,15230s031ltr.pdf 8/25/2004
AP08/19/2008SLR20658043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/015230s035, 015197s043ltr.pdf 8/22/2008
AP08/19/2008SLR20666043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/015197s043,015230s035lbl.pdf 8/26/2008




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