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FDA Drug Application 020198 by ALVOGEN

Application Number020198
Application Type New Drug Application
Sponsor ApplicantALVOGEN
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
AP04/21/1993N       
AP07/23/1993SLR       
AP012/6/1993SCS       
AP07/7/1994SLR       
AP07/28/1994SCP       
AP03/29/1996SCP       
AP06/14/1995SCM       
AP01/24/1996SCP       
AP03/14/1996SCM       
AP07/23/1996SCM       
AP012/18/1998SCM       
AP04/13/1999SCM       
AP04/1/2005SLR11346017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20198s017ltr.pdf 4/6/2005
AP04/1/2005SLR11354017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20198s017lbl.pdf 4/6/2005
AP03/3/2010SLR24967022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020198s022lbl.pdf 3/5/2010
AP03/3/2010SLR24994022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020198s022ltr.pdf 3/8/2010
AP02/28/2011SLR27995023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020198s023lbl.pdf 2/28/2011
AP02/28/2011SLR28014023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020198s023ltr.pdf 3/2/2011
AP03/9/2015SCM       
AP05/17/2016SCM       
AP08/29/2016SCM       




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