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FDA Drug Application 050444 by REMPEX PHARMS INC

Application Number050444
Application Type New Drug Application
Sponsor ApplicantREMPEX PHARMS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/26/1972N       
AP07/25/1984SCS       
AP01/10/1986SLR       
AP010/6/1987SLR       
AP011/7/1988SCS       
AP08/28/1991SLR       
AP05/12/1992SLR       
AP02/8/1973SCF       
AP06/28/1973SCS       
AP08/31/1973SCF       
AP010/4/1973SLR       
AP011/4/1974SLR       
AP03/21/1975SE2       
AP05/12/1975SCF       
AP012/24/1975SCS       
AP06/25/1976SCS       
AP08/11/1976SCM       
AP01/14/1977SCS       
AP06/8/1978SCS       
AP07/12/1978SCS       
AP04/12/1978SLR       
AP06/27/1978SCS       
AP01/30/2002SLR3604029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50444s34ltr.pdf 1/30/2002
AP03/4/1996SCS       
AP03/29/1996SLR       
AP01/30/2002SLR3605033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50444s34ltr.pdf 1/30/2002
AP01/30/2002SLR3606034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50444s34ltr.pdf 1/30/2002
AP07/29/1997SCS       
AP05/31/2002SLR3597036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50444s036ltr.pdf 5/31/2002
AP05/31/2002SLR9593036   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/50-444S036_Minocin.cfm 6/29/2004
AP06/21/2001SCM       
AP02/17/2005SLR11119038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/50444s038,50445s022,50649s015ltr.pdf 2/17/2005
AP05/27/2004SLR8864042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50444slr042,043ltr.pdf 6/1/2004
AP05/27/2004SLR8865043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50444slr042,043ltr.pdf 6/1/2004
AP09/28/2005SLR12834044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050444s044lbl.pdf 9/30/2005
AP09/28/2005SLR12925044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050444s044,050445s026,050649s018ltr.pdf 10/20/2005
AP01/16/2007SLR15682045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050444s045,050445s027lbl.pdf 1/18/2007
AP01/16/2007SLR15687045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050444s045, 050445s027ltr.pdf 1/18/2007
AP09/14/2010SLR26494047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050444s047ltr.pdf 9/17/2010
AP09/14/2010SLR26508047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050444s047lbl.pdf 9/20/2010
AP010/23/2014SLR40880048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050444Orig1s048ltr.pdf 10/27/2014
AP010/23/2014SLR41021048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050444s048lbl.pdf 11/18/2014
AP04/17/2015SCM42626049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050444s049lbl.pdf 4/22/2015




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