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FDA Drug Application 050405 by PRAGMA PHARMS LLC

Application Number050405
Application Type New Drug Application
Sponsor ApplicantPRAGMA PHARMS LLC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/4/1971N       
AP09/5/1984SCS       
AP02/8/1971SCS       
AP011/4/1985SCS       
AP011/22/1985SLR       
AP08/21/1986SE1       
AP07/7/1971SLR       
AP08/6/1971SLR       
AP08/29/1986SLR       
AP03/4/1987SCM       
AP03/4/1987SLR       
AP02/17/1987SE1       
AP09/21/1988SLR       
AP04/10/1990SLR       
AP08/27/1992SLR       
AP010/9/1991SCS       
AP01/7/1971SCM       
AP04/14/1971SLR       
AP05/13/1971SLR       
AP05/19/1971SLR       
AP07/1/1971SLR       
AP010/19/1971SCE       
AP010/6/1971SLR       
AP011/30/1971SCS       
AP012/13/1971SCS       
AP01/12/1972SCS       
AP02/24/1972SLR       
AP012/13/1972SLR       
AP07/19/1972SCS       
AP012/13/1972SLR       
AP01/18/1973SCS       
AP02/15/1973SCS       
AP04/27/1973SLR       
AP06/4/1973SLR       
AP06/19/1973SLR       
AP06/25/1973SLR       
AP07/25/1973SCS       
AP07/31/1973SLR       
AP010/2/1973SLR       
AP011/8/1973SCE       
AP01/15/1974SCS       
AP01/24/1974SCS       
AP02/20/1974SCE       
AP03/6/1974SLR       
AP06/28/1974SLR       
AP05/24/1974SLR       
AP07/10/1974SCF       
AP08/16/1974SLR       
AP08/22/1974SLR       
AP08/28/1974SLR       
AP010/4/1974SE1       
AP09/3/1974SLR       
AP010/2/1974SLR       
AP012/13/1974SLR       
AP04/7/1975SCE       
AP07/8/1975SLR       
AP07/31/1975SCS       
AP08/4/1975SLR       
AP08/12/1975SLR       
AP09/4/1975SLR       
AP09/8/1975SLR       
AP09/16/1975SLR       
AP010/24/1975SLR       
AP011/17/1975SLR       
AP03/10/1976SCS       
AP03/10/1976SCS       
AP04/9/1976SLR       
AP04/22/1976SLR       
AP06/8/1976SLR       
AP08/10/1976SCS       
AP09/2/1976SLR       
AP09/8/1976SLR       
AP09/8/1976SLR       
AP012/10/1976SCS       
AP012/10/1976SCS       
AP012/17/1976SLR       
AP02/28/1977SLR       
AP03/9/1977SCS       
AP03/15/1977SCS       
AP04/22/1977SLR       
AP04/28/1977SCE       
AP05/25/1977SCM       
AP011/4/1988SCM       
AP02/13/1995SLR       
AP05/15/1996SLR       
AP07/27/2001SCM       
AP011/19/2004SLR10665092   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50405s092ltr.pdf 12/2/2004
AP010/23/2002SCS       
AP01/15/2004SLR7594094   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50405slr094ltr.pdf 1/22/2004
AP01/15/2004SLR7616094   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50405slr094_keflex_lbl.pdf 1/22/2004
AP06/25/2004SLR9689095   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50405slr095ltr.pdf 7/1/2004
AP05/12/2006SE814102097   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050405s097lbl.pdf 5/16/2006
AP05/12/2006SE814104097   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050405s097ltr.pdf 5/16/2006
AP05/21/2008SLR19869099   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050405s099ltr.pdf 5/21/2008
AP09/16/2008SLR20789101   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050405s101ltr.pdf 9/17/2008
AP012/30/2013SCM       
AP010/30/2015SLR44361106   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050405Orig1s106ltr.pdf 11/4/2015
AP010/30/2015SLR44363106   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050405s106lbl.pdf 11/4/2015




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