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FDA Drug Application 050261 by COREPHARMA

Application Number050261
Application Type New Drug Application
Sponsor ApplicantCOREPHARMA
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
AP09/22/1964N       
AP06/21/1983SCS       
AP02/10/1965SLR       
AP010/9/1986SLR       
AP012/17/1987SCF       
AP011/20/1991SLR       
AP03/11/1965SLR       
AP05/14/1965SCM       
AP05/14/1965SCM       
AP09/24/1965SCP       
AP08/19/1965SLR       
AP012/23/1965SE2       
AP012/13/1965SLR       
AP012/7/1965SLR       
AP01/13/1966SLR       
AP01/13/1966SLR       
AP012/22/1965SLR       
AP01/5/1966SLR       
AP01/5/1966SLR       
AP03/14/1966SLR       
AP02/18/1966SLR       
AP03/11/1966SLR       
AP03/25/1966SLR       
AP05/4/1966SLR       
AP05/4/1966SLR       
AP05/4/1966SLR       
AP05/4/1966SLR       
AP05/4/1966SLR       
AP05/4/1966SLR       
AP05/4/1966SLR       
AP05/4/1966SLR       
AP05/4/1966SLR       
AP05/4/1966SLR       
AP06/3/1966SLR       
AP07/6/1966SLR       
AP09/15/1966SCF       
AP012/5/1966SLR       
AP09/28/1966SLR       
AP09/28/1966SLR       
AP011/29/1966SLR       
AP012/29/1966SCP       
AP012/29/1966SCP       
AP02/20/1967SLR       
AP02/15/1967SLR       
AP04/25/1967SLR       
AP04/25/1967SLR       
AP04/25/1967SLR       
AP011/17/1967SLR       
AP012/7/1967SLR       
AP01/3/1969SCP       
AP04/14/1970SCF       
AP010/23/1970SCE       
AP010/23/1970SCE       
AP012/1/1970SCF       
AP06/14/1971SCF       
AP07/14/1971SLR       
AP01/10/1972SLR       
AP01/10/1972SLR       
AP01/10/1972SLR       
AP02/16/1972SLR       
AP02/16/1972SCP       
AP02/16/1972SCP       
AP010/1/1973SLR       
AP010/1/1973SLR       
AP010/1/1973SLR       
AP01/10/1974SCF       
AP02/28/1974SLR       
AP04/25/1974SCE       
AP07/8/1975SCS       
AP012/29/1975SCS       
AP03/22/1976SCS       
AP06/25/1976SCE       
AP08/25/1976SCS       
AP06/7/1978SLR       
AP09/14/1978SCE       
AP09/20/1978SCF       
AP05/16/1979SCS       
AP04/8/1980SCS       
AP03/26/1982SCP       
AP06/25/1997SCP       
AP06/25/1997SCM       
AP010/20/1999SCS       
AP012/7/2000SCS       
AP012/18/2003SLR7302094   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50261slr094ltr.pdf 12/22/2003
AP05/1/2003SLR5754095   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50261slr095ltr.pdf 5/30/2003
AP012/18/2003SLR7303097   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50261slr094ltr.pdf 12/22/2003
AP04/22/2008SLR19721100   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050261s100ltr.pdf 4/25/2008
AP04/22/2008SLR19954100   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050261s100lbl.pdf 6/5/2008
AP09/5/2012SLR33665101   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050261s101lbl.pdf 9/6/2012
AP09/5/2012SLR33682101   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050261Orig1s101ltr.pdf 9/7/2012




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