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FDA Drug Application 017681 by US PHARM HOLDINGS

Application Number017681
Application Type New Drug Application
Sponsor ApplicantUS PHARM HOLDINGS
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
AP09/9/1976N       
AP02/24/1978SCS       
AP02/27/1978SCM       
AP011/25/1980SLR       
AP011/25/1980SLR       
AP03/19/1981SDS       
AP05/26/1982SCS       
AP04/25/1984SCP       
AP05/3/1984SCM       
AP01/3/1989SCM       
AP04/28/1988SCP       
AP08/9/1988SCM       
AP06/10/2004SLR9367013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17681slr013ltr.pdf 6/15/2004
AP06/10/2004SLR9381013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17681slr013_hiprex_lbl.pdf 6/15/2004
AP011/21/2005SLR13141014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/17681s014lbl.pdf 11/30/2005
AP011/21/2005SLR13151014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/17681s014ltr.pdf 11/30/2005
AP08/1/2016SCM       




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