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FDA Drug Application 017558 by EUROHLTH INTL SARL

Application Number017558
Application Type New Drug Application
Sponsor ApplicantEUROHLTH INTL SARL
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/6/1975N15828000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/017558_S000_RobinulTOC.cfm 2/20/2007
AP011/5/1975SLR       
AP09/22/1976SCS       
AP011/2/1976SLR       
AP04/25/1978SLR       
AP08/17/1978SLR       
AP08/17/1978SLR       
AP011/30/1978SCS       
AP04/1/1980SCS       
AP04/1/1980SLR       
AP04/1/1980SCS       
AP04/1/1980SLR       
AP012/4/1980SLR       
AP09/26/1980SCS       
AP010/22/1981SCS       
AP010/22/1981SLR       
AP010/22/1981SLR       
AP09/24/1981SCS       
AP011/6/1981SCE       
AP01/19/1982SCS       
AP03/4/1982SCM       
AP03/2/1983SCS       
AP03/2/1983SCS       
AP07/24/1986SCS       
AP06/12/1986SCS       
AP06/12/1986SCS       
AP03/16/1987SCS       
AP04/18/1988SCS       
AP06/6/1988SCS       
AP09/6/1988SCF       
AP02/13/1998SCM       
AP04/26/2001SCM       
AP011/5/2004SLR10532045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17558s045,046,049,050ltr.pdf 11/8/2004
AP011/5/2004SLR10533046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17558s045,046,049,050ltr.pdf 11/8/2004
AP06/30/2003SLR6033047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17558slr047,048ltr.pdf 7/6/2003
AP06/30/2003SLR6034048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17558slr047,048ltr.pdf 7/6/2003
AP011/5/2004SLR10534049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17558s045,046,049,050ltr.pdf 11/8/2004
AP011/5/2004SLR10535050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17558s045,046,049,050ltr.pdf 11/8/2004
AP05/26/2005SLR11727053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017558s053ltr.pdf 5/27/2005
AP05/26/2005SLR11743053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017558s053lbl.pdf 5/27/2005
AP03/18/2014SCM       




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